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Lung protective mechanical ventilation versus regular mechanical ventilation in patients undergoing vascular surgery of the lower limbs.

Protective versus conventional mechanical ventilation for peripheral vascular surgery: a randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5stpwb
Enrollment
Unknown
Registered
2018-08-07
Start date
2017-04-15
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Diseases

Interventions

Control group: 28 patients scheduled to undergo lower limb bypass surgery submitted to conventional mechanical ventilation (tidal volume of 9 to 10 ml / kg of predicted body weight and PEEP between 3
Procedure/surgery

Sponsors

Hospital de Clinicas de Porto Alegre
Lead Sponsor
Hospital de Clinicas de Porto Alegre
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult ASA II to IV patients; older than 18 years; scheduled to undergo arterial bypass surgery in the lower limbs.

Exclusion criteria

Exclusion criteria: Patients with a body mass index above 40 kg / m2; submitted to emergency surgery; with a history of pulmonary surgery; persistent hemodynamic instability in the preoperative period; history of asthma or chronic use of corticosteroids; or patients with a history of neuromuscular disorder.

Design outcomes

Primary

MeasureTime frame
Evaluate the effects of mechanical ventilation with a protective strategy (treatment group - low tidal volume and high PEEP) in comparison to conventional mechanical ventilation (control group - high tidal volume and reduced PEEP) on the incidence of pulmonary complications (primary composite endpoint: insufficiency pulmonary infiltrates, pleural effusions, bronchospasm, cardiopulmonary edema, acute respiratory distress syndrome (ARDS)) in the perioperative period of patients undergoing coronary artery bypass graft surgery (CABG). Measures performed by clinical, laboratory or radiological means.

Secondary

MeasureTime frame
Evaluate the effects of mechanical ventilation with a protective strategy (treatment group - low tidal volume and high PEEP) compared to conventional mechanical ventilation (control group - high tidal volume and reduced PEEP) on the incidence of cardiovascular complications (secondary outcome composed of events coronary syndromes, non-fatal infarction and / or cardiogenic shock) in the perioperative period of patients submitted to lower limb bypass surgery. Measures performed by clinical or laboratory means.;Evaluate the effects of mechanical ventilation with a protective strategy (treatment group - low tidal volume and high PEEP) compared to conventional mechanical ventilation (control group - high tidal volume and reduced PEEP) on the incidence of hemodynamic complications (secondary outcome consisting of shock distributive or persistent hypotension requiring the use of vasoactive drugs) in the perioperative period of patients submitted to lower limb bypass surgery. Measures performed through clinical or laboratory means.;Evaluate the effects of mechanical ventilation with a protective strategy (treatment group - low tidal volume and high PEEP) compared to conventional mechanical ventilation (control group - high tidal volume and reduced PEEP) on pulmonary and gasometric parameters in the perioperative period of patients undergoing lower limb bypass surgery. Measures performed through laboratory means.

Countries

Brazil

Contacts

Public ContactAndre Schmidt

Hospital de Clinicas de Porto Alegre

apschmidtus@yahoo.com51996412212

Outcome results

None listed

Source: REBEC (via WHO ICTRP)