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Protective Versus Conventional Mechanical Ventilation for Peripheral Vascular Surgery.

Primary Purpose

Lung Diseases

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Protective ventilation
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Diseases focused on measuring mechanical ventilation, protective ventilation, vascular surgery, postoperative pulmonary complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • This study enrolled only patients displaying peripheral occlusive arterial disease and scheduled to undergo an elective peripheral artery bypass surgery.

Exclusion Criteria:

  • The illiterate or who do not understand Portuguese language, those who had a body-mass index (BMI) higher than 35 kg/m2, had severe pulmonary comorbidities or another disorder that might compromise a safe trial procedure and those who refused to participate of the study or who had already participated in other studies.

Sites / Locations

  • Andre P Schmidt

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Protective ventilation

Conventional ventilation

Arm Description

Protective ventilation strategy (tidal volume of 6 to 7 ml.kg-1 of predicted body weight and PEEP of 6 to 8 cmH2O)

Conventional mechanical ventilation (tidal volume between 9 to 10 ml.kg-1 of predicted body weight and PEEP between 3 and 5 cmH2O)

Outcomes

Primary Outcome Measures

Postoperative pulmonary complications
The main outcome was the presence of any pulmonary complication (composite endpoint) after surgery and until discharge. These pulmonary complications included severe hypoxemia, suspected pulmonary infection, documented atelectasis or pulmonary infiltrate, bronchospasm, pulmonary edema, pleural effusion, pneumothorax, or development of ARDS. The presence of at least one of the findings described above was considered as a positive primary outcome.

Secondary Outcome Measures

Perioperative hemodynamic complications
Hypotension and need for continuous vasopressors (i.e., systolic arterial blood pressure < 90 mmHg for more than 5 min).

Full Information

First Posted
April 26, 2018
Last Updated
July 31, 2018
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT03616210
Brief Title
Protective Versus Conventional Mechanical Ventilation for Peripheral Vascular Surgery.
Official Title
Protective Versus Conventional Mechanical Ventilation for Peripheral Vascular Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 15, 2017 (Actual)
Primary Completion Date
April 15, 2018 (Actual)
Study Completion Date
April 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background and goal of the study: Postoperative complications following major surgeries are associated with a significant increase in costs and mortality. There is increasing evidence that mechanical ventilation with a protective strategy using low tidal volume prevents postoperative pulmonary complications. Peripheral vascular surgeries include particularly surgeries for arterial revascularization of the lower limbs in patients with advanced peripheral vascular disease. These procedures are strongly associated with major cardiovascular morbidity postoperatively. In this specific group of patients, the presence of postoperative pulmonary complications (PPC) may be associated with worsening of clinical outcomes with a consequent significant increase in perioperative morbidity. Subjects and methods: In this study, the investigators aimed to compare the effects of controlled mechanical ventilation with the use of a protective strategy (low tidal volume associated with elevated PEEP) when compared to the conventional strategy (higher tidal volume associated with reduced PEEP levels) on the rate of PPC in patients undergoing peripheral vascular surgery. This study was delineated as a prospective trial, compared to the control group (conventional ventilation strategy). Patients and researchers were blinded during data collection. The investigators included adult patients, ASA status II to IV, aged over 18 years, scheduled to undergo lower limb arterial bypass surgery. Patients were randomized to treatment with conventional mechanical ventilation (tidal volume between 9 to 10 ml.kg-1 of predicted body weight and PEEP between 3 and 5 cmH2O - Group I or control) or treatment with protective ventilation strategy (tidal volume of 6 to 7 ml.kg-1 of predicted body weight and PEEP of 6 to 8 cmH2O - Group II or treatment). The primary outcome was PPC and the secondary endpoint included hemodynamic and metabolic changes perioperatively. Statistical analysis was performed using the intention-to-treat method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases
Keywords
mechanical ventilation, protective ventilation, vascular surgery, postoperative pulmonary complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Protective ventilation
Arm Type
Experimental
Arm Description
Protective ventilation strategy (tidal volume of 6 to 7 ml.kg-1 of predicted body weight and PEEP of 6 to 8 cmH2O)
Arm Title
Conventional ventilation
Arm Type
No Intervention
Arm Description
Conventional mechanical ventilation (tidal volume between 9 to 10 ml.kg-1 of predicted body weight and PEEP between 3 and 5 cmH2O)
Intervention Type
Procedure
Intervention Name(s)
Protective ventilation
Intervention Description
Protective ventilation strategy with tidal volume of 6 to 7 ml.kg-1 of predicted body weight and PEEP of 6 to 8 cmH2O.
Primary Outcome Measure Information:
Title
Postoperative pulmonary complications
Description
The main outcome was the presence of any pulmonary complication (composite endpoint) after surgery and until discharge. These pulmonary complications included severe hypoxemia, suspected pulmonary infection, documented atelectasis or pulmonary infiltrate, bronchospasm, pulmonary edema, pleural effusion, pneumothorax, or development of ARDS. The presence of at least one of the findings described above was considered as a positive primary outcome.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Perioperative hemodynamic complications
Description
Hypotension and need for continuous vasopressors (i.e., systolic arterial blood pressure < 90 mmHg for more than 5 min).
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: This study enrolled only patients displaying peripheral occlusive arterial disease and scheduled to undergo an elective peripheral artery bypass surgery. Exclusion Criteria: The illiterate or who do not understand Portuguese language, those who had a body-mass index (BMI) higher than 35 kg/m2, had severe pulmonary comorbidities or another disorder that might compromise a safe trial procedure and those who refused to participate of the study or who had already participated in other studies.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre P Schmidt, MD, PhD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Andre P Schmidt
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Protective Versus Conventional Mechanical Ventilation for Peripheral Vascular Surgery.

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