Home Non-invasive Ventilation for Chronic Obstructive Pulmonary Disease Patients
NIVOLD
1 other identifier
interventional
12
1 country
1
Brief Summary
Chronic Obstructive Pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure are more likely to develop exacerbations. Non-invasive ventilation has been proposed to treat acute respiratory failure but little information is available about the benefits of home non-invasive ventilation in COPD patients with chronic hypercapnic respiratory failure surviving an acute hypercapnic respiratory failure. The purpose of this study is to determine whether home non-invasive ventilation can reduce recurrent acute hypercapnic respiratory failure in COPD patients who survived an episode of acute hypoxemic respiratory failure (AHRF) treated by Non-invasive ventilation (NIV).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease
Started Dec 2011
Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease
1 active site
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
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 23, 2012
CompletedFirst Posted
Study publicly available on registry
February 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedAugust 22, 2017
August 1, 2017
2 years
January 23, 2012
August 21, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Acute hypercapnic respiratory failure episode
up to 102 weeks
Secondary Outcomes (1)
Death
1 month and every 6 months during 2 years
Study Arms (2)
Long Term Oxygen Therapy
NO INTERVENTIONNon Invasive Ventilation
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age \> 18 years old
- COPD patients who survived after an episode of acute hypercapnic respiratory failure
- Patients weaned from ventilation (non invasive ventilation or mechanical ventilation) for acute episode since at least seven days with stable arterial blood gas since at least two days: PaCO2 \> 55 mmHg and pH \> 7.35
You may not qualify if:
- Age \> 85 years old
- Non- COPD causes of respiratory failure
- Obstructive sleep apnea excluded by polysomnography
- Adverse psychosocial status
- Serious co-morbidity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Rouen
Rouen, 76000, France
Related Publications (1)
Lamia B, Cuvelier A, Benichou J, Muir JF. [A multi-centre randomized controlled trial of domiciliary non-invasive ventilation vs long-term oxygen therapy in survivors of acute hypercapnic respiratory failure due to COPD. Non-invasive ventilation in obstructive lung disease (NIVOLD) study]. Rev Mal Respir. 2012 Nov;29(9):1141-8. doi: 10.1016/j.rmr.2012.09.006. Epub 2012 Oct 16. French.
PMID: 23200590DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2012
First Posted
February 6, 2012
Study Start
December 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2015
Last Updated
August 22, 2017
Record last verified: 2017-08