Clinical Trial Assessing Two Protocols to Withdraw Non-invasive Ventilation in Hypercapnic Respiratory Failure
A Randomized Controlled Trial Comparing Two Protocols to Withdraw Non-invasive Ventilation (NIV) After an Episode of Hypercapnic Respiratory Failure
1 other identifier
interventional
128
1 country
3
Brief Summary
The purpose of the study is to determine the optimal method to withdraw non-invasive ventilation after an episode of hypercapnic respiratory failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2006
Longer than P75 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 17, 2008
CompletedFirst Posted
Study publicly available on registry
October 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedJune 22, 2011
October 1, 2008
4.4 years
October 17, 2008
June 21, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
New episode of hypercapnic respiratory failure after discontinuation of non-invasive ventilation
At the end of enrollment time
Secondary Outcomes (2)
Incidence of long term dependency on non-invasive ventilation
At the end of enrollment time
Hospital and 6-month survival
At the end of enrollment time
Study Arms (2)
1
ACTIVE COMPARATORNon-invasive ventilation is maintained during three nights after recovery of an episode of hypercapnic respiratory failure.
2
NO INTERVENTIONDiscontinuation of NIV after the recovery of hypercapnic respiratory failure, without prolong it during night.
Interventions
Eligibility Criteria
You may qualify if:
- Acute hypercapnic respiratory failure.
- Use of NIV to treat respiratory failure.
- Persistence of hypercapnia after discontinuation of NIV
You may not qualify if:
- Home NIV
- Facial or cranial trauma or surgery,
- Recent gastric or esophageal surgery,
- Active upper gastrointestinal bleeding,
- Excessive amount of respiratory secretions,
- Tracheostomy
- Lack of cooperation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Hospital del Mar
Barcelona, Barcelona, 08003, Spain
Hospital de Sant Pau
Barcelona, Barcelona, 08025, Spain
Hospital Clinic
Barcelona, Barcelona, 08036, Spain
Related Publications (1)
Sellares J, Ferrer M, Anton A, Loureiro H, Bencosme C, Alonso R, Martinez-Olondris P, Sayas J, Penacoba P, Torres A. Discontinuing noninvasive ventilation in severe chronic obstructive pulmonary disease exacerbations: a randomised controlled trial. Eur Respir J. 2017 Jul 5;50(1):1601448. doi: 10.1183/13993003.01448-2016. Print 2017 Jul.
PMID: 28679605DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacobo Sellares, MD
Hospital Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 17, 2008
First Posted
October 20, 2008
Study Start
March 1, 2006
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
June 22, 2011
Record last verified: 2008-10