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Home Non-invasive Ventilation for Chronic Obstructive Pulmonary Disease Patients (NIVOLD)

Primary Purpose

Chronic Obstructive Pulmonary Disease, Hypercapnic Respiratory Failure

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Non Invasive Ventilation
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Age > 85 years old
  • Non- COPD causes of respiratory failure
  • Obstructive sleep apnea excluded by polysomnography
  • Adverse psychosocial status
  • Serious co-morbidity

Sites / Locations

  • CHU de Rouen

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Long Term Oxygen Therapy

Non Invasive Ventilation

Arm Description

Outcomes

Primary Outcome Measures

Acute hypercapnic respiratory failure episode

Secondary Outcome Measures

Death

Full Information

First Posted
January 23, 2012
Last Updated
August 21, 2017
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT01526642
Brief Title
Home Non-invasive Ventilation for Chronic Obstructive Pulmonary Disease Patients
Acronym
NIVOLD
Official Title
Home Non-invasive Ventilation Versus Long-term Oxygen Therapy in COPD Survivors of Acute Hypercapnic Respiratory Failure. A Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Hypercapnic Respiratory Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Long Term Oxygen Therapy
Arm Type
No Intervention
Arm Title
Non Invasive Ventilation
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Non Invasive Ventilation
Intervention Description
NIV during night
Primary Outcome Measure Information:
Title
Acute hypercapnic respiratory failure episode
Time Frame
up to 102 weeks
Secondary Outcome Measure Information:
Title
Death
Time Frame
1 month and every 6 months during 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Age > 85 years old Non- COPD causes of respiratory failure Obstructive sleep apnea excluded by polysomnography Adverse psychosocial status Serious co-morbidity
Facility Information:
Facility Name
CHU de Rouen
City
Rouen
ZIP/Postal Code
76000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
23200590
Citation
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.
Results Reference
derived

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Home Non-invasive Ventilation for Chronic Obstructive Pulmonary Disease Patients

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