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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lung Resection

Intervention / Treatment
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* Device: CPAP plus Gas
* Device: ventimask plus gas


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP plus gas<br>Treatment with Boussingnac valve CPAP during 6 hour, starting immediately after weaning | Device: CPAP plus Gas<br> <br> |
| Active Comparator: Usual treatment(ventimask plus gas)<br>ventimask | Device: ventimask plus gas<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of atelectasis- Pneumonia, and other postoperative complications, |  | 1 week after the surgical intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |