Skip to main content
OpenTrials
Completed

NCT Number: NCT02771327

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lung Resection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

H. Ramón y Cajal, Madrid, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CPAP plus Gas

Device

ventimask plus gas

Device

Primary outcomes

  1. Frequency of atelectasis- Pneumonia, and other postoperative complications,

    Time frame: 1 week after the surgical intervention

Secondary outcomes

  1. Gas exchange ( Pa/FiO2)

    Time frame: 1 week after the surgical intervention

  2. Hospital stay comparison between arms

    Time frame: from the surgical intervention date to hospital discharge date up to 1month

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Gregorio Marañon

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 13, 2016
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.