General Versus Regional Anaesthesia in Peripheral Arterial Surgery: Incidence of Postoperative Pulmonary Complications.

Sponsor
Hospital de Clinicas de Porto Alegre (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04566016
Collaborator
(none)
120
1
2
41
2.9

Study Details

Study Description

Brief Summary

The study will be designed as a prospective clinical trial. Patients scheduled for lower limb arterial bypass surgery will be randomly allocated for treatment with spinal anesthesia associated with spontaneous ventilation (nasal cannula with supplemental oxygen - Group 1) or treatment with general anesthesia under controlled mechanical ventilation (tidal volume 6 to 8 ml / kg of the predicted body weight and PEEP of 5 cmH2O - Group 2).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Regional anesthesia
N/A

Detailed Description

In this prospective and randomized study, only adult ASA II to IV patients, aged over 18 years, scheduled to undergo lower limb arterial revascularization surgery at the Hospital de Clínicas in Porto Alegre and at the Hospital Nossa Senhora da Conceição will be included.

The study will be designed as a prospective clinical trial. Patients will be randomly allocated for treatment with spinal neuraxial anesthesia associated with spontaneous ventilation (nasal glasses with supplemental oxygen - Group 1) or treatment with general anesthesia under controlled mechanical ventilation (tidal volume from 6 to 8 ml / kg of the assumed weight and PEEP of 5 cmH2O - Group 2).

Sampling will be carried out for convenience, including patients routinely seen in the operating room of the hospitals involved and who meet the inclusion and exclusion criteria of this study. The allocation of patients will be performed through a table of random numbers generated prior to the beginning of the protocol. The process of randomization of patients in the groups will be carried out using random blocks. The method for blinding the study will be carried out using sealed envelopes and will include the blinding of the researchers, evaluators and those responsible for statistical analysis, but will not include the blinding of the attending physician and the patients.

The data will be stored in Excel and analyzed statistically using STATA 12.0 software. The statistical approach will be carried out through the "intention-to-treat" model. The assessment of ventilatory and hemodynamic parameters between the groups will be performed using ANOVA associated with Bonferroni for parametric data or the Kruskal-Wallis test associated with the Mann-Whitney test for nonparametric data. For categorical variables, we will use Fisher's exact test or Chi-square test. Repeated measures ANOVA will be used to assess outcomes between treatment groups over the follow-up period. In order to control important variables, such as surgical time, surgical complications, age, body mass index, and ASA classification (comorbidities), a statistical approach to assess confounding factors (linear regression model) will be performed after the period data collection. Results will be considered statistically significant when type I (P) error is less than 0.05.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized parallel controlled trial.Randomized parallel controlled trial.
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
General Versus Regional Anaesthesia in Peripheral Arterial Surgery: Effects on the Incidence of Postoperative Pulmonary Complications.
Actual Study Start Date :
Feb 28, 2019
Actual Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Regional anesthesia

Patients scheduled for lower limb arterial bypass surgery and allocated for treatment with spinal anesthesia associated with spontaneous ventilation (nasal cannula with supplemental oxygen - Group 1).

Procedure: Regional anesthesia
Patients scheduled for lower limb arterial bypass surgery will be randomly allocated for treatment with spinal anesthesia associated with spontaneous ventilation (nasal cannula with supplemental oxygen - Group 1) or treatment with general anesthesia under controlled mechanical ventilation (tidal volume 6 to 8 ml / kg of the predicted body weight and PEEP of 5 cmH2O - Group 2).
Other Names:
  • Spinal anesthesia
  • Active Comparator: General anesthesia

    Patients scheduled for lower limb arterial bypass surgery and allocated for treatment with general anesthesia under controlled mechanical ventilation (tidal volume 6 to 8 ml / kg of the predicted body weight and PEEP of 5 cmH2O - Group 2).

    Procedure: Regional anesthesia
    Patients scheduled for lower limb arterial bypass surgery will be randomly allocated for treatment with spinal anesthesia associated with spontaneous ventilation (nasal cannula with supplemental oxygen - Group 1) or treatment with general anesthesia under controlled mechanical ventilation (tidal volume 6 to 8 ml / kg of the predicted body weight and PEEP of 5 cmH2O - Group 2).
    Other Names:
  • Spinal anesthesia
  • Outcome Measures

    Primary Outcome Measures

    1. Incidence of postoperative pulmonary complications. [7 days]

      To evaluate the effects of spinal neuroaxial anesthesia under spontaneous ventilation (group 1) in relation to general anesthesia under mechanical ventilation (group 2) on the incidence of pulmonary complications (primary endpoint composed: mild respiratory failure / hypoxemia, severe respiratory failure, suspected pulmonary infection , atelectasis, acute lung injury, barotrauma, pulmonary infiltrate, pleural effusion, bronchospasm, cardiopulmonary edema, acute respiratory distress syndrome - ARDS) in the perioperative period of patients undergoing lower limb bypass surgery.

    Secondary Outcome Measures

    1. Incidence of hemodynamic complications (secondary outcome consisting of distributive shock or persistent hypotension requiring use of vasoactive drugs) [7 days]

      To evaluate the effects of spinal neuroaxial anesthesia under spontaneous ventilation (group 1) in relation to general anesthesia under mechanical ventilation (group 2) on the incidence of hemodynamic complications (secondary outcome consisting of distributive shock or persistent hypotension requiring use of vasoactive drugs) in the perioperative period of patients undergoing lower limb bypass surgery.

    2. Incidence of minor ventilatory complications related to the ventilation strategy (desaturation) in the intraoperative period. [7 days]

      To evaluate the effects of spinal neuroaxial anesthesia under spontaneous ventilation (group 1) in relation to general anesthesia under mechanical ventilation (group 2) on the incidence of minor ventilatory complications related to the ventilation strategy (desaturation) in the intraoperative period of patients undergoing lower limb bypass surgery.

    3. Perioperative pulmonary, gasometric and inflammatory physiological parameters. [7 days]

      To evaluate the effects of spinal neuraxial anesthesia under spontaneous ventilation (group 1) in relation to general anesthesia under mechanical ventilation (group 2) on perioperative pulmonary, gasometric and inflammatory physiological parameters of patients undergoing lower limb bypass surgery.

    4. Hemodynamic parameters in the perioperative period. [7 days]

      To evaluate the effects of spinal neuroaxial anesthesia under spontaneous ventilation (group 1) in relation to general anesthesia under mechanical ventilation (group 2) on hemodynamic parameters in the perioperative period of patients undergoing lower limb bypass surgery.

    5. Incidence of various extrapulmonary complications, in-hospital mortality, length of stay in the post-recovery room -anesthetic, and length of hospital stay. [7 days]

      To evaluate the effects of spinal neuraxial anesthesia under spontaneous ventilation (group 1) in relation to general anesthesia under mechanical ventilation (group 2) on the incidence of various extrapulmonary complications (Annex 2), in-hospital mortality, length of stay in the post-recovery room -anesthetic, and length of hospital stay in patients undergoing lower limb bypass surgery.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adult patients ASA II to IV; age greater than 18 years; scheduled for arterial revascularization surgery on lower limbs.
    Exclusion Criteria:
    • Patients with a body mass index above 40 kg / m2 who underwent emergency surgery, with a history of pulmonary surgery, persistent hemodynamic instability in the preoperative period, history of asthma or chronic use of corticotherapy, or patients with history neuromuscular disorder. Patients with a history of use of anticoagulants or antiplatelet agents in the preoperative period who contraindicate the performance of spinal anesthesia will also be excluded from the study. In this study, only patients with peripheral vascular disease with critical and symptomatic ischemia in the lower limbs and scheduled to undergo elective arterial revascularization of the lower limbs will be included, and all patients with acute vascular obstruction or other associated vascular complications will be excluded.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Andre Prato Schmidt Porto Alegre RS Brazil 90035903

    Sponsors and Collaborators

    • Hospital de Clinicas de Porto Alegre

    Investigators

    • Principal Investigator: Andre P Schmidt, Hospital de Clinicas de Porto Alegre
    • Study Chair: Cristiano F Andrade, Hospital de Clinicas de Porto Alegre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hospital de Clinicas de Porto Alegre
    ClinicalTrials.gov Identifier:
    NCT04566016
    Other Study ID Numbers:
    • 95165518.6.0000.5327
    • RBR-72fpz2
    First Posted:
    Sep 28, 2020
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Mar 1, 2022
    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 Hospital de Clinicas de Porto Alegre
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 7, 2022