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

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ClinicalTrials.gov Identifier: NCT04566016
Recruitment Status : Recruiting
First Posted : September 28, 2020
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Tracking Information
First Submitted Date  ICMJE September 22, 2020
First Posted Date  ICMJE September 28, 2020
Last Update Posted Date September 28, 2020
Actual Study Start Date  ICMJE February 28, 2019
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2020)
Incidence of postoperative pulmonary complications. [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2020)
  • Incidence of hemodynamic complications (secondary outcome consisting of distributive shock or persistent hypotension requiring use of vasoactive drugs) [ Time Frame: 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.
  • Incidence of minor ventilatory complications related to the ventilation strategy (desaturation) in the intraoperative period. [ Time Frame: 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.
  • Perioperative pulmonary, gasometric and inflammatory physiological parameters. [ Time Frame: 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.
  • Hemodynamic parameters in the perioperative period. [ Time Frame: 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.
  • Incidence of various extrapulmonary complications, in-hospital mortality, length of stay in the post-recovery room -anesthetic, and length of hospital stay. [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE General Versus Regional Anaesthesia in Peripheral Arterial Surgery: Incidence of Postoperative Pulmonary Complications.
Official Title  ICMJE General Versus Regional Anaesthesia in Peripheral Arterial Surgery: Effects on the Incidence of Postoperative Pulmonary Complications.
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized parallel controlled trial.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Peripheral Vascular Diseases
Intervention  ICMJE 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 Name: Spinal anesthesia
Study Arms  ICMJE
  • 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).
    Intervention: Procedure: Regional 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).
    Intervention: Procedure: Regional anesthesia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 22, 2020)
118
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Andre P Schmidt, MD, MSc, PhD +5551996412212 apschmidt@hcpa.edu.br
Contact: Cristiano F Andrade +5551997393215 cfandrade@hcpa.edu.br
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04566016
Other Study ID Numbers  ICMJE 95165518.6.0000.5327
RBR-72fpz2 ( Other Identifier: Registro Brasileiro de Ensaios Clínicos (ReBEC) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hospital de Clinicas de Porto Alegre
Study Sponsor  ICMJE Hospital de Clinicas de Porto Alegre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andre P Schmidt Hospital de Clinicas de Porto Alegre
Study Chair: Cristiano F Andrade Hospital de Clinicas de Porto Alegre
PRS Account Hospital de Clinicas de Porto Alegre
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP