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
1 other identifier
interventional
258
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2014
Typical duration for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 4, 2016
CompletedFirst Posted
Study publicly available on registry
May 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedNovember 18, 2016
November 1, 2016
2.6 years
April 4, 2016
November 17, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency of atelectasis- Pneumonia, and other postoperative complications,
1 week after the surgical intervention
Secondary Outcomes (2)
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
Study Arms (2)
CPAP plus gas
EXPERIMENTALTreatment with Boussingnac valve CPAP during 6 hour, starting immediately after weaning
Usual treatment(ventimask plus gas)
ACTIVE COMPARATORventimask
Interventions
Eligibility Criteria
You may qualify if:
- Undergoing thoracic surgery including resection of lung parenchyma.
- To have given signed consent to enter in the study.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Hopsital universitario La Princesa
Madrid, Madrid, 28006, Spain
HGU Gregorio Marañón
Madrid, Madrid, 28007, Spain
H. Ramón y Cajal
Madrid, Madrid, 28034, Spain
HU 12 de octubre
Madrid, Madrid, 28041, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2016
First Posted
May 13, 2016
Study Start
February 1, 2014
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
November 18, 2016
Record last verified: 2016-11