Trials / Completed
CompletedNCT02771327
Use of a Pressurized Face Mask for Preventing Respiratory Complications After Chest Surgery
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
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 258 (actual)
- Sponsor
- Hospital General Universitario Gregorio Marañon · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CPAP plus Gas | |
| DEVICE | ventimask plus gas |
Timeline
- Start date
- 2014-02-01
- Primary completion
- 2016-09-01
- Completion
- 2016-09-01
- First posted
- 2016-05-13
- Last updated
- 2016-11-18
Locations
4 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT02771327. Inclusion in this directory is not an endorsement.