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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02771327

Enrollment

258

Registered

2016-05-13

Start date

2014-02-28

Completion date

2016-09-30

Last updated

2016-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Resection

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.

Interventions

DEVICECPAP plus Gas

DEVICEventimask plus gas

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

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

Secondary

Measure	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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026