Protective Versus Conventional Mechanical Ventilation for Peripheral

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Lung Diseases

Clinical Trial Details

NCT number	NCT03616210
Study type	Interventional
Source	Hospital de Clinicas de Porto Alegre
Contact
Status	Completed
Phase	N/A
Start date	April 15, 2017
Completion date	April 16, 2018

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Protective Versus Conventional Mechanical Ventilation for Peripheral Vascular Surgery.

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms