MedDataX Logo

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

NCT ID: NCT02771327

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Resection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CPAP plus gas

Treatment with Boussingnac valve CPAP during 6 hour, starting immediately after weaning

Group Type EXPERIMENTAL

CPAP plus Gas

Intervention Type DEVICE

Usual treatment(ventimask plus gas)

ventimask

Group Type ACTIVE_COMPARATOR

ventimask plus gas

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CPAP plus Gas

Intervention Type DEVICE

ventimask plus gas

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

Hospital General Universitario Gregorio Marañon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hopsital universitario La Princesa

Madrid, Madrid, Spain

Site Status

HGU Gregorio Marañón

Madrid, Madrid, Spain

Site Status

H. Ramón y Cajal

Madrid, Madrid, Spain

Site Status

HU 12 de octubre

Madrid, Madrid, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FIBHGM-ECNC010-2010

Identifier Type: -

Identifier Source: org_study_id