Goal Directed Fluid Therapy Guided Fluid Management in Pneumoresection

Sponsor
ZhiHeng Liu (Other)
Overall Status
Completed
CT.gov ID
NCT03237351
Collaborator
(none)
60
1
3
30
2

Study Details

Study Description

Brief Summary

Perioperative fluid management is a key component of anesthetic management during thoracic surgery. On one hand, fluid restriction could compromise perfusion of vital organs and surgical anastomosis. On the other hand, fluid overload could lead to cardiopulmonary complications, notably pulmonary edema, which carries a high mortality rate. Perioperative fluid management to avoid postpneumonectomy pulmonary edema has been previously reviewed. Therefore, to achieve the balance between preventing fluid overload and optimising organ perfusion, the practical index to guide fluid management, which can predict whether fluid loading will improve haemodynamic conditions in an individual patient, would be very valuable during lung surgery. Perioperative goal-directed fluid therapy (GDFT) is a cornerstone of tissue perfusion and oxygenation, and it can improve surgical outcomes. Respiratory variations of arterial pressure [i.e. pulse pressure variation (PPV) and systolic pressure variation] can predict fluid responsiveness in mechanically ventilated patients under various conditions. Therefore, pressure variations are increasingly being advocated for fluid management.This study will discuss the effects of pulse pressure variation(PPV) in different level during anesthesia on patients with oxygenation index and short-term prognosis undergoing video-assisted thoracoscopic surgery for pneumoresection.

Condition or Disease Intervention/Treatment Phase
  • Device: Fluid therapy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Goal Directed Fluid Therapy Guided Fluid Management in Pneumoresection: a Randomized Controlled Trial
Actual Study Start Date :
Sep 1, 2017
Actual Primary Completion Date :
Jan 1, 2020
Actual Study Completion Date :
Mar 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Conventional therapy group

Patients in Conventional therapy group were received fluid therapy: intraoperative transfusion volume=maintenance fluids+deficit replacement+restoration of losses and with heart rate, mean arterial pressure, urine measurement ect.

Device: Fluid therapy
Conventional therapy group: conventional arterial blood pressure monitoring. Low value of PPV group and high value of PPV group:pulse pressure variation monitoring with arterial blood pressure monitoring.

Experimental: Low value of PPV group

Patients in low value of PPV group were received fluid therapy according to PPV (3% ≤PPV < 5%) .

Device: Fluid therapy
Conventional therapy group: conventional arterial blood pressure monitoring. Low value of PPV group and high value of PPV group:pulse pressure variation monitoring with arterial blood pressure monitoring.

Experimental: High value of PPV group

Patients in high value of PPV group were received fluid therapy according to PPV (5% ≤PPV < 8%) .

Device: Fluid therapy
Conventional therapy group: conventional arterial blood pressure monitoring. Low value of PPV group and high value of PPV group:pulse pressure variation monitoring with arterial blood pressure monitoring.

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline Oxygenation Index in 48 hours [Before induction, 5 minutes before the end of one-lung ventilation, 48 hours after the operation]

Secondary Outcome Measures

  1. The duration of surgery [During surgery period]

  2. The duration of mechanical ventilation [During surgery period]

  3. Crystalloid administered [During surgery period]

  4. Colloid administered [During surgery period]

  5. Blood loss [During surgery period]

  6. Urine output [During surgery period]

  7. Number of patients received vasopressor [During surgery period]

  8. Blood pressure [Before the surgery and 48 hours after surgery]

  9. Leukocyte [Before the surgery and 48 hours after surgery]

  10. Hematocrit [Before the surgery and 48 hours after surgery]

  11. Complication until hospital discharge [1 month after surgery]

  12. Hospital stay postoperatively [1 month after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • American Society of Anesthesiologists physical status I-III; aged 18-60 years old; BMI 18.5 ~ 28 kg/m2
Exclusion Criteria:
  • Refused to participate in the experiment, hepatic/renal/cardiac dysfunction, severe valvular disease, frequent arrhythmia, moderate anemia and severe electrolyte disturbance before operation.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shenzhen Second People's Hospital Shenzhen Guangdong China 518035

Sponsors and Collaborators

  • ZhiHeng Liu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
ZhiHeng Liu, Chair of Department of Anesthesiology, Shenzhen Second People's Hospital
ClinicalTrials.gov Identifier:
NCT03237351
Other Study ID Numbers:
  • 2017041102
First Posted:
Aug 2, 2017
Last Update Posted:
Apr 22, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ZhiHeng Liu, Chair of Department of Anesthesiology, Shenzhen Second People's Hospital

Study Results

No Results Posted as of Apr 22, 2020