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

Hospital General Universitario Gregorio Marañon

Status and phase

Completed

Phase 4

Conditions

Lung Resection

Treatments

Device: ventimask plus gas

Device: CPAP plus Gas

Study type

Interventional

Funder types

Other

Identifiers

NCT02771327

FIBHGM-ECNC010-2010

Details and patient eligibility

About

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.

Full 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.

Enrollment

258 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)