Use of a Pressurized Face Mask for Preventing Respiratory Complications After Chest Surgery

Lung Resection Clinical Trial

Official title: Phase 4, Randomized, Controlled Trial on the Efficacy as Prophylaxis of Postoperative Respiratory Complications and Safety of Continuous Positive Airways Pressure (CPAP) Applied Throughout Boussignac Mask During the Immediate Postoperative Period of Patients Undergoing Lung Resection

Status Completed

Clinical Trial Summary

Evaluation of efficacy and safety from 6hours of 7 cmH2O CPAP after weaning in patients undergoing lung resection, on the prevention of atelectasis / pneumonia and gas exchange improve.

Clinical Trial Description

Multicenter randomized clinical trial. 460 patients randomly assigned to treatment and control groups will be studied. The main variables are the frequency of atelectasis or pneumonia, defined by clinical and radiological criteria, the FiO2/PaO2 ratio, 7 and 24 h after weaning, and hospital stay. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lung Resection

• NCT number: NCT02771327
• Study type: Interventional
• Source: Hospital General Universitario Gregorio Marañon
• Status: Completed
• Phase: Phase 4
• Start date: February 2014
• Completion date: September 2016