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

Phase 4

Completed

• Conditions: Lung Resection
• Interventions: Device: ventimask plus gas; Device: CPAP plus Gas

• Registration Number: NCT02771327
• Lead Sponsor: Hospital General Universitario Gregorio Marañon

Brief 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.

Detailed 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 Timeline

• Study Start: 2014-02
• Study First Submitted: 2016-04-04
• Study First Submitted QC: 2016-05-11
• Study First Posted: 2016-05-13
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-17
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

Inclusion Criteria

• Undergoing thoracic surgery including resection of lung parenchyma.
• To have given signed consent to enter in the study.

Exclusion Criteria

Weaning in the first 4h after the intervention end.

• Suspected bronchopleural fistula at the admission to the surgical ICU.
• Patients with facial problems or a history of intolerance to CPAP masks.
• Having significant bullous emphysema defined as the presence of more than 5 contiguous bullae <2cm or the existence of a pulmonary bulla> 2 cm or dystrophy bullosa, not in the area to dry and having had a previous pneumothorax.
• Known Obstructive Apnea Hypopnea syndrome known or some form of noninvasive ventilation prescribed.
• Immunocompromised patients, or having used an immunosuppressor drug at least one month prior to surgery with potential (except corticosteroids administered by inhalation)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual treatment(ventimask plus gas)	ventimask plus gas	ventimask
CPAP plus gas	CPAP plus Gas	Treatment with Boussingnac valve CPAP during 6 hour, starting immediately after weaning

Primary Outcome Measures

Name	Time	Method
Frequency of atelectasis- Pneumonia, and other postoperative complications,	1 week after the surgical intervention

Secondary Outcome Measures

Name	Time	Method
Gas exchange ( Pa/FiO2)	1 week after the surgical intervention
Hospital stay comparison between arms	from the surgical intervention date to hospital discharge date up to 1month

Trial Locations

Locations (4)

H. Ramón y Cajal; 🇪🇸 Madrid, Spain

HGU Gregorio Marañón; 🇪🇸 Madrid, Spain

Hopsital universitario La Princesa; 🇪🇸 Madrid, Spain

HU 12 de octubre; 🇪🇸 Madrid, Spain