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Goal Directed Therapy Versus Standard Care in Lung Resection Surgery (GDT-thorax Study).

Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla (Other)
Overall Status
Completed
CT.gov ID
NCT03245372
Collaborator
(none)
31
Enrollment
1
Location
2
Arms
11.7
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary aim of this study is to quantify and compare the hemodynamic control of cardiac index in patients who receive either goal-directed therapy or standard hemodynamic management in lung resection surgery

Condition or Disease Intervention/Treatment Phase
  • Procedure: Standard care
  • Procedure: Goal directed therapy
 N/A

Detailed Description

The investigators hypothesize that the percentage of the intraoperative time in which the cardiac index is equal or superior to 2.2 l/min/m2 is higher in goal directed therapy

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Goal Directed Therapy Versus Standard Care in Lung Resection Surgery, a Randomized, Controlled Trial (GDT-thorax Study).
Actual Study Start Date :
Oct 10, 2017
Actual Primary Completion Date :
Mar 23, 2018
Actual Study Completion Date :
Sep 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard care

Basic intraoperative hemodynamic objectives

Procedure: Standard care
Heart rate 60-100 beats per minute, mean arterial pressure 65 mm Hg, serum lactate 2 mmol/L, oxygen saturation 95 % (90 % during one lung ventilation).
Other Names:
  • Conventional fluid and hemodynamic management

    		•
    Experimental: Goal directed therapy

    Target value is a cardiac index equal or superior to 2.2 l/min/m2.

    Procedure: Goal directed therapy
    The hemodynamic algorithm will be based on systolic volume index and fluid challenges. FloTrac sensor (this sensor connects to any existing arterial catheter and provides advanced hemodynamic parameters through pulse contour analysis) and EV1000 clinical platform (clinical platform from Edwards Lifesciences that provides advanced hemodynamic monitoring) will be used to calculate cardiac index and systolic volume index.
    Other Names:
  • Goal directed fluid and hemodynamic management

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of the Intraoperative Time in Which the Cardiac Index is Equal or Superior to 2.2 l/Min/m2 (%) [During the total duration of the surgery, on average 4 hours. We include the time from the start of maintenance of general anesthesia to the moment of extubation of the patient.]

      To compare the degree of hemodynamic control of cardiac index in both groups: Percentage of the intraoperative time in which the cardiac index is equal or superior to 2.2 l/min/m2.

    Secondary Outcome Measures

    1. Tissue Perfusion Marker: Lactate [Within 24 hours after lung surgery]

      To compare lactate in the first 24 hours in both groups

    2. Tissue Perfusion Marker: SvcO2 [Within 24 hours after lung surgery]

      To compare SvcO2 (central venous oxygen saturation) in the first 24 hours in both groups

    3. Oxygenation Marker: PaO2/FiO2 Ratio [Within 24 hours after lung surgery]

      To compare PaO2/FiO2 ratio (ratio of arterial oxygen partial pressure to fractional inspired oxygen) in the first 24 hours in both groups

    4. Fluid Balance [After 24 hours of finalization of lung surgery]

      To compare fluid balance (differences between the amount of water taken into the body and the amount excreted or lost) in the first 24 hours in both groups

    5. Observation of Acute Kidney Injury (AKI) [After 72 hours of finalization of lung surgery]

      To compare the Number of Participants with Acute Kidney Injury in both groups

    6. Observation of Acute Respiratory Distress Syndrome (ARDS) [Within 30 days after lung surgery]

      To compare the he Number of Participants with Acute Respiratory Distress Syndrome in both groups

    7. Duration of Hospital Stay [Within 30 days after lung surgery]

      To compare hospital stay in both groups

    8. Mortality [Within 30 days after lung surgery]

      To compare the mortality rate in both groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adults patients ( 18 years old)

    • Written informed consent

    • Elective lung resection surgery (open or thoracoscopic lung lobectomy)

    Exclusion Criteria:

    • Severe obesity

    • Moderate to severe aortic insufficiency

    • Renal failure requiring hemodialysis

    • Left ventricle ejection fraction less than 35 %

    • Urgent surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University hospital Virgen del Rocío Sevilla Spain 41013

    Sponsors and Collaborators

    • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    Investigators

    • Study Chair: Manuel Bertomeu, MD-PhD, Andaluz Health Service

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
    ClinicalTrials.gov Identifier:
    NCT03245372
    Other Study ID Numbers:
    • 2017/118
    First Posted:
    Aug 10, 2017
    Last Update Posted:
    Oct 20, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
    cardiac output
    perioperative care
    postoperative complications

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 31 patients signed informed consent, but there was a pre-randomization exclusion (a patient was selected and signed informed consent) because surgeons decided to carry out a less aggressive surgery from the start (atypical lung resection instead of lobectomy). That happened in only one case.
    Arm/Group Title Standard Care Goal Directed Therapy
    Arm/Group Description Basic intraoperative hemodynamic objectives Standard care: Heart rate 60-100 beats per minute, mean arterial pressure 65 mm Hg, serum lactate 2 mmol/L, oxygen saturation 95 % (90 % during one lung ventilation). Target value is a cardiac index equal or superior to 2.2 l/min/m2. Goal directed therapy: The hemodynamic algorithm will be based on systolic volume index and fluid challenges. FloTrac sensor (this sensor connects to any existing arterial catheter and provides advanced hemodynamic parameters through pulse contour analysis) and EV1000 clinical platform (clinical platform from Edwards Lifesciences that provides advanced hemodynamic monitoring) will be used to calculate cardiac index and systolic volume index.
    Period Title: Overall Study
    STARTED 15 15
    COMPLETED 15 15
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Standard Care Goal Directed Therapy Total
    Arm/Group Description Basic intraoperative hemodynamic objectives Standard care: Heart rate 60-100 beats per minute, mean arterial pressure 65 mm Hg, serum lactate 2 mmol/L, oxygen saturation 95 % (90 % during one lung ventilation). Target value is a cardiac index equal or superior to 2.2 l/min/m2. Goal directed therapy: The hemodynamic algorithm will be based on systolic volume index and fluid challenges. FloTrac sensor (this sensor connects to any existing arterial catheter and provides advanced hemodynamic parameters through pulse contour analysis) and EV1000 clinical platform (clinical platform from Edwards Lifesciences that provides advanced hemodynamic monitoring) will be used to calculate cardiac index and systolic volume index. Total of all reporting groups
    Overall Participants 15 15 30
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    67.4
    (9.91)
    67.33
    (8.64)
    67.37
    (9.137)
    Sex: Female, Male (Count of Participants)
    Female
    4
    26.7%
    2
    13.3%
    6
    20%
    Male
    11
    73.3%
    13
    86.7%
    24
    80%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    White
    15
    100%
    15
    100%
    30
    100%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    Spain
    15
    100%
    15
    100%
    30
    100%
    Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    25.96
    (4.35)
    24.64
    (3.39)
    25.3
    (3.89)
    Smoking history (Count of Participants)
    Count of Participants [Participants]
    12
    80%
    13
    86.7%
    25
    83.3%
    Smoking exposure (pack-years) [Median (Standard Deviation) ]
    Median (Standard Deviation) [pack-years]
    33.79
    (31.27)
    34.07
    (20.15)
    33.93
    (25.85)
    ASA Physical Status Classification System (Count of Participants)
    ASA II
    3
    20%
    8
    53.3%
    11
    36.7%
    ASA III
    12
    80%
    7
    46.7%
    19
    63.3%
    Hypertension (Count of Participants)
    Count of Participants [Participants]
    9
    60%
    11
    73.3%
    20
    66.7%
    Dyslipidemia (Count of Participants)
    Count of Participants [Participants]
    9
    60%
    7
    46.7%
    16
    53.3%
    Diabetes Mellitus (Count of Participants)
    Count of Participants [Participants]
    3
    20%
    4
    26.7%
    7
    23.3%
    Ischemic heart disease (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    3
    20%
    3
    10%
    Atrial fibrillation (Count of Participants)
    Count of Participants [Participants]
    2
    13.3%
    1
    6.7%
    3
    10%
    Chronic kidney disease (Count of Participants)
    Count of Participants [Participants]
    2
    13.3%
    3
    20%
    5
    16.7%
    COPD grade GOLD is equal or superior to 2 (Count of Participants)
    Count of Participants [Participants]
    2
    13.3%
    3
    20%
    5
    16.7%
    cerebrovascular disease (Count of Participants)
    Count of Participants [Participants]
    2
    13.3%
    1
    6.7%
    3
    10%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of the Intraoperative Time in Which the Cardiac Index is Equal or Superior to 2.2 l/Min/m2 (%)
    Description To compare the degree of hemodynamic control of cardiac index in both groups: Percentage of the intraoperative time in which the cardiac index is equal or superior to 2.2 l/min/m2.
    Time Frame During the total duration of the surgery, on average 4 hours. We include the time from the start of maintenance of general anesthesia to the moment of extubation of the patient.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Standard Care Goal Directed Therapy
    Arm/Group Description Basic intraoperative hemodynamic objectives Standard care: Heart rate 60-100 beats per minute, mean arterial pressure 65 mm Hg, serum lactate 2 mmol/L, oxygen saturation 95 % (90 % during one lung ventilation). Target value is a cardiac index equal or superior to 2.2 l/min/m2. Goal directed therapy: The hemodynamic algorithm will be based on systolic volume index and fluid challenges. FloTrac sensor (this sensor connects to any existing arterial catheter and provides advanced hemodynamic parameters through pulse contour analysis) and EV1000 clinical platform (clinical platform from Edwards Lifesciences that provides advanced hemodynamic monitoring) will be used to calculate cardiac index and systolic volume index.
    Measure Participants 15 15
    Median (Inter-Quartile Range) [percentage of time]
    97
    91
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Standard Care, Goal Directed Therapy
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.114
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    2. Secondary Outcome
    Title Tissue Perfusion Marker: Lactate
    Description To compare lactate in the first 24 hours in both groups
    Time Frame Within 24 hours after lung surgery

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Standard Care Goal Directed Therapy
    Arm/Group Description Basic intraoperative hemodynamic objectives Standard care: Heart rate 60-100 beats per minute, mean arterial pressure 65 mm Hg, serum lactate 2 mmol/L, oxygen saturation 95 % (90 % during one lung ventilation). Target value is a cardiac index equal or superior to 2.2 l/min/m2. Goal directed therapy: The hemodynamic algorithm will be based on systolic volume index and fluid challenges. FloTrac sensor (this sensor connects to any existing arterial catheter and provides advanced hemodynamic parameters through pulse contour analysis) and EV1000 clinical platform (clinical platform from Edwards Lifesciences that provides advanced hemodynamic monitoring) will be used to calculate cardiac index and systolic volume index.
    Measure Participants 15 15
    Median (Inter-Quartile Range) [mmol/L]
    0.70
    0.80
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Standard Care, Goal Directed Therapy
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.692
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    3. Secondary Outcome
    Title Tissue Perfusion Marker: SvcO2
    Description To compare SvcO2 (central venous oxygen saturation) in the first 24 hours in both groups
    Time Frame Within 24 hours after lung surgery

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Standard Care Goal Directed Therapy
    Arm/Group Description Basic intraoperative hemodynamic objectives Standard care: Heart rate 60-100 beats per minute, mean arterial pressure 65 mm Hg, serum lactate 2 mmol/L, oxygen saturation 95 % (90 % during one lung ventilation). Target value is a cardiac index equal or superior to 2.2 l/min/m2. Goal directed therapy: The hemodynamic algorithm will be based on systolic volume index and fluid challenges. FloTrac sensor (this sensor connects to any existing arterial catheter and provides advanced hemodynamic parameters through pulse contour analysis) and EV1000 clinical platform (clinical platform from Edwards Lifesciences that provides advanced hemodynamic monitoring) will be used to calculate cardiac index and systolic volume index.
    Measure Participants 15 15
    Mean (Standard Deviation) [percentage of saturation]
    66.03
    (7.16)
    70.16
    (5.14)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Standard Care, Goal Directed Therapy
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.082
    Comments
    Method t-test, 2 sided
    Comments
    4. Secondary Outcome
    Title Oxygenation Marker: PaO2/FiO2 Ratio
    Description To compare PaO2/FiO2 ratio (ratio of arterial oxygen partial pressure to fractional inspired oxygen) in the first 24 hours in both groups
    Time Frame Within 24 hours after lung surgery

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Standard Care Goal Directed Therapy
    Arm/Group Description Basic intraoperative hemodynamic objectives Standard care: Heart rate 60-100 beats per minute, mean arterial pressure 65 mm Hg, serum lactate 2 mmol/L, oxygen saturation 95 % (90 % during one lung ventilation). Target value is a cardiac index equal or superior to 2.2 l/min/m2. Goal directed therapy: The hemodynamic algorithm will be based on systolic volume index and fluid challenges. FloTrac sensor (this sensor connects to any existing arterial catheter and provides advanced hemodynamic parameters through pulse contour analysis) and EV1000 clinical platform (clinical platform from Edwards Lifesciences that provides advanced hemodynamic monitoring) will be used to calculate cardiac index and systolic volume index.
    Measure Participants 15 15
    Median (Inter-Quartile Range) [mm Hg]
    331.43
    339.05
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Standard Care, Goal Directed Therapy
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.443
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    5. Secondary Outcome
    Title Fluid Balance
    Description To compare fluid balance (differences between the amount of water taken into the body and the amount excreted or lost) in the first 24 hours in both groups
    Time Frame After 24 hours of finalization of lung surgery

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Standard Care Goal Directed Therapy
    Arm/Group Description Basic intraoperative hemodynamic objectives Standard care: Heart rate 60-100 beats per minute, mean arterial pressure 65 mm Hg, serum lactate 2 mmol/L, oxygen saturation 95 % (90 % during one lung ventilation). Target value is a cardiac index equal or superior to 2.2 l/min/m2. Goal directed therapy: The hemodynamic algorithm will be based on systolic volume index and fluid challenges. FloTrac sensor (this sensor connects to any existing arterial catheter and provides advanced hemodynamic parameters through pulse contour analysis) and EV1000 clinical platform (clinical platform from Edwards Lifesciences that provides advanced hemodynamic monitoring) will be used to calculate cardiac index and systolic volume index.
    Measure Participants 15 15
    Mean (Standard Deviation) [milliliters]
    647.17
    (700.57)
    748.83
    (579.46)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Standard Care, Goal Directed Therapy
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.668
    Comments
    Method t-test, 2 sided
    Comments
    6. Secondary Outcome
    Title Observation of Acute Kidney Injury (AKI)
    Description To compare the Number of Participants with Acute Kidney Injury in both groups
    Time Frame After 72 hours of finalization of lung surgery

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Standard Care Goal Directed Therapy
    Arm/Group Description Basic intraoperative hemodynamic objectives Standard care: Heart rate 60-100 beats per minute, mean arterial pressure 65 mm Hg, serum lactate 2 mmol/L, oxygen saturation 95 % (90 % during one lung ventilation). Target value is a cardiac index equal or superior to 2.2 l/min/m2. Goal directed therapy: The hemodynamic algorithm will be based on systolic volume index and fluid challenges. FloTrac sensor (this sensor connects to any existing arterial catheter and provides advanced hemodynamic parameters through pulse contour analysis) and EV1000 clinical platform (clinical platform from Edwards Lifesciences that provides advanced hemodynamic monitoring) will be used to calculate cardiac index and systolic volume index.
    Measure Participants 15 15
    Count of Participants [Participants]
    3
    20%
    5
    33.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Standard Care, Goal Directed Therapy
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.516
    Comments
    Method Chi-squared
    Comments
    7. Secondary Outcome
    Title Observation of Acute Respiratory Distress Syndrome (ARDS)
    Description To compare the he Number of Participants with Acute Respiratory Distress Syndrome in both groups
    Time Frame Within 30 days after lung surgery

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Standard Care Goal Directed Therapy
    Arm/Group Description Basic intraoperative hemodynamic objectives Standard care: Heart rate 60-100 beats per minute, mean arterial pressure 65 mm Hg, serum lactate 2 mmol/L, oxygen saturation 95 % (90 % during one lung ventilation). Target value is a cardiac index equal or superior to 2.2 l/min/m2. Goal directed therapy: The hemodynamic algorithm will be based on systolic volume index and fluid challenges. FloTrac sensor (this sensor connects to any existing arterial catheter and provides advanced hemodynamic parameters through pulse contour analysis) and EV1000 clinical platform (clinical platform from Edwards Lifesciences that provides advanced hemodynamic monitoring) will be used to calculate cardiac index and systolic volume index.
    Measure Participants 15 15
    Count of Participants [Participants]
    0
    0%
    0
    0%
    8. Secondary Outcome
    Title Duration of Hospital Stay
    Description To compare hospital stay in both groups
    Time Frame Within 30 days after lung surgery

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Standard Care Goal Directed Therapy
    Arm/Group Description Basic intraoperative hemodynamic objectives Standard care: Heart rate 60-100 beats per minute, mean arterial pressure 65 mm Hg, serum lactate 2 mmol/L, oxygen saturation 95 % (90 % during one lung ventilation). Target value is a cardiac index equal or superior to 2.2 l/min/m2. Goal directed therapy: The hemodynamic algorithm will be based on systolic volume index and fluid challenges. FloTrac sensor (this sensor connects to any existing arterial catheter and provides advanced hemodynamic parameters through pulse contour analysis) and EV1000 clinical platform (clinical platform from Edwards Lifesciences that provides advanced hemodynamic monitoring) will be used to calculate cardiac index and systolic volume index.
    Measure Participants 15 15
    Median (Inter-Quartile Range) [days]
    4
    5
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Standard Care, Goal Directed Therapy
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.229
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    9. Secondary Outcome
    Title Mortality
    Description To compare the mortality rate in both groups
    Time Frame Within 30 days after lung surgery

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Standard Care Goal Directed Therapy
    Arm/Group Description Basic intraoperative hemodynamic objectives Standard care: Heart rate 60-100 beats per minute, mean arterial pressure 65 mm Hg, serum lactate 2 mmol/L, oxygen saturation 95 % (90 % during one lung ventilation). Target value is a cardiac index equal or superior to 2.2 l/min/m2. Goal directed therapy: The hemodynamic algorithm will be based on systolic volume index and fluid challenges. FloTrac sensor (this sensor connects to any existing arterial catheter and provides advanced hemodynamic parameters through pulse contour analysis) and EV1000 clinical platform (clinical platform from Edwards Lifesciences that provides advanced hemodynamic monitoring) will be used to calculate cardiac index and systolic volume index.
    Measure Participants 15 15
    Count of Participants [Participants]
    1
    6.7%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Standard Care, Goal Directed Therapy
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 1
    Comments
    Method Fisher Exact
    Comments

    Adverse Events

    Time Frame 30 days
    Adverse Event Reporting Description
    Arm/Group Title Standard Care Goal Directed Therapy
    Arm/Group Description Basic intraoperative hemodynamic objectives Standard care: Heart rate 60-100 beats per minute, mean arterial pressure 65 mm Hg, serum lactate 2 mmol/L, oxygen saturation 95 % (90 % during one lung ventilation). Target value is a cardiac index equal or superior to 2.2 l/min/m2. Goal directed therapy: The hemodynamic algorithm will be based on systolic volume index and fluid challenges. FloTrac sensor (this sensor connects to any existing arterial catheter and provides advanced hemodynamic parameters through pulse contour analysis) and EV1000 clinical platform (clinical platform from Edwards Lifesciences that provides advanced hemodynamic monitoring) will be used to calculate cardiac index and systolic volume index.
    All Cause Mortality
    Standard Care Goal Directed Therapy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/15 (6.7%) 0/15 (0%)
    Serious Adverse Events
    Standard Care Goal Directed Therapy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/15 (20%) 4/15 (26.7%)
    Cardiac disorders
    Thoracic Pain 1/15 (6.7%) 1 0/15 (0%) 0
    Atrial Fibrillation Paroxysmal 1/15 (6.7%) 1 1/15 (6.7%) 1
    Respiratory, thoracic and mediastinal disorders
    Acute Pneumonia 2/15 (13.3%) 2 1/15 (6.7%) 1
    Haemothorax 0/15 (0%) 0 1/15 (6.7%) 1
    Skin and subcutaneous tissue disorders
    Severe Subcutaneous Emphysema 0/15 (0%) 0 1/15 (6.7%) 1
    Other (Not Including Serious) Adverse Events
    Standard Care Goal Directed Therapy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 12/15 (80%) 14/15 (93.3%)
    Cardiac disorders
    Arterial Hypotension 4/15 (26.7%) 4 9/15 (60%) 9
    Gastrointestinal disorders
    Postoperative Nausea and Vomiting 3/15 (20%) 3 4/15 (26.7%) 4
    General disorders
    Fever 1/15 (6.7%) 1 0/15 (0%) 0
    Renal and urinary disorders
    Acute Kidney Injury 3/15 (20%) 3 5/15 (33.3%) 5
    Skin and subcutaneous tissue disorders
    Exanthema 1/15 (6.7%) 1 0/15 (0%) 0
    Surgical Site Infection 1/15 (6.7%) 1 0/15 (0%) 0
    Mild-Moderate Subcutaneous Emphysema 0/15 (0%) 0 2/15 (13.3%) 2

    Limitations/Caveats

    This is a pilot study and the clinician (anesthesiologist) who performed the anesthetic procedure had to know the assignment of the arm. The intervention was limited to the intraoperative period. Postoperative morbidity and mortality surveillance was limited to one month. The study, therefore, was not designed to have sufficient power to detect significant differences in major postoperative complications.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Alejandro Domínguez-Blanco
    Organization Hospital Universitario Virgen del Rocío, Servicio Andaluz de Salud
    Phone 0034660762856
    Email aledguez@gmail.com
    Responsible Party:
    Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
    ClinicalTrials.gov Identifier:
    NCT03245372
    Other Study ID Numbers:
    • 2017/118
    First Posted:
    Aug 10, 2017
    Last Update Posted:
    Oct 20, 2021
    Last Verified:
    Oct 1, 2021