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

November 17, 2016 updated by: Hospital General Universitario Gregorio Marañon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

258

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28034
        • H. Ramón y Cajal
      • Madrid, Spain, 28006
        • Hopsital universitario La Princesa
      • Madrid, Spain, 28007
        • HGU Gregorio Marañon
      • Madrid, Spain, 28041
        • HU 12 de Octubre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Gas exchange ( Pa/FiO2)
Time Frame: 1 week after the surgical intervention
1 week after the surgical intervention
Hospital stay comparison between arms
Time Frame: from the surgical intervention date to hospital discharge date up to 1month
from the surgical intervention date to hospital discharge date up to 1month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Gregorio Marañon

Collaborators

Instituto de Salud Carlos III

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

April 4, 2016

First Submitted That Met QC Criteria

May 11, 2016

First Posted (Estimate)

May 13, 2016

Study Record Updates

Last Update Posted (Estimate)

November 18, 2016

Last Update Submitted That Met QC Criteria

November 17, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • FIBHGM-ECNC010-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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