Home Non Invasive Ventilation for COPD Patients (NIVOLD)
Primary Purpose
Chronic Obstructive Pulmonary Disease, Hypercapnic Respiratory Failure
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Home ventilator
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- COPD patients who survived after an acute episode of hypercapnic respiratory failure
- patients weaned from ventilation ( non invasive ventilation or mechanical ventilation) prescribed for acute episode since at least five days with following arterial blood gas : pH > 7.35 and PCO2 > = 45 mmHg
Exclusion Criteria:
- severe obstructive sleep apnea ( DI > 30/h)
- Non COPD cause of respiratory failure
- Serious comorbidity
- Adverse psychological status
Sites / Locations
- CH DieppeRecruiting
- CH ElbeufRecruiting
- Le Havre, Jacques Monod HospitalRecruiting
- CHU de RouenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Long Term Oxygen Therapy alone
Non invasive ventilation
Arm Description
Long Term oxygen therapy is prescribed according to the guidelines
Home non invasive ventilation is prescribed with the following settings PS mode IPAP according to clinical and hemodynamic tolerance EPAP according to air trapping RR around 12/ min. LOT for SaO2 > 90% Monitoring with capnometry for settings validation
Outcomes
Primary Outcome Measures
acute hypercapnic respiratory failure episode
first episode of acute hypercapnic respiratory failure episode requiring hospitalization
Secondary Outcome Measures
acute hypercapnic respiratory failure episode rate
pulmonary function test
Six Minute Walk Distance
Quality of life
Heart function
left and right heart function assessed using echocardiography
Cost effectiveness
mortality
arterial blood gas
Full Information
NCT ID
NCT03221101
First Posted
July 12, 2017
Last Updated
July 19, 2017
Sponsor
University Hospital, Rouen
Collaborators
ADIR Association
1. Study Identification
Unique Protocol Identification Number
NCT03221101
Brief Title
Home Non Invasive Ventilation for COPD Patients
Acronym
NIVOLD
Official Title
Home Non Invasive Ventilation Versus Long Term Oxygen Therapy Alone in COPD Survivors After Acute Hypercapnic Respiratory Failure. A French Multicenter Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Recruiting
Study Start Date
December 2011 (Actual)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Rouen
Collaborators
ADIR Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Chronic Obstructive Pulmonary Disease (COPD) patients are more likely to develop acute hypercapnic respiratory failure. In the acute phase, non invasive ventilation has been shown to improve mortality and reduce intubation rate. Few studies are available about long term benefits of home non invasive ventilation in COPD patients with chronic hypercapnic respiratory failure who survived after an acute episode. 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 acute hypercapnic respiratory failure episode treated by non invasive ventilation.
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
86 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Long Term Oxygen Therapy alone
Arm Type
No Intervention
Arm Description
Long Term oxygen therapy is prescribed according to the guidelines
Arm Title
Non invasive ventilation
Arm Type
Active Comparator
Arm Description
Home non invasive ventilation is prescribed with the following settings
PS mode
IPAP according to clinical and hemodynamic tolerance
EPAP according to air trapping
RR around 12/ min.
LOT for SaO2 > 90%
Monitoring with capnometry for settings validation
Intervention Type
Device
Intervention Name(s)
Home ventilator
Primary Outcome Measure Information:
Title
acute hypercapnic respiratory failure episode
Description
first episode of acute hypercapnic respiratory failure episode requiring hospitalization
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
acute hypercapnic respiratory failure episode rate
Time Frame
up to 24 months
Title
pulmonary function test
Time Frame
at one month and every six months up to 24 months
Title
Six Minute Walk Distance
Time Frame
at one month and every six months up to 24 months
Title
Quality of life
Time Frame
at one month and every six months up to 24 months
Title
Heart function
Description
left and right heart function assessed using echocardiography
Time Frame
at one month and every six months up to 24 months
Title
Cost effectiveness
Time Frame
at one month and every six months up to 24 months
Title
mortality
Time Frame
at one month and every six months up to 24 months
Title
arterial blood gas
Time Frame
at one month and every six months up to 24 months
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:
COPD patients who survived after an acute episode of hypercapnic respiratory failure
patients weaned from ventilation ( non invasive ventilation or mechanical ventilation) prescribed for acute episode since at least five days with following arterial blood gas : pH > 7.35 and PCO2 > = 45 mmHg
Exclusion Criteria:
severe obstructive sleep apnea ( DI > 30/h)
Non COPD cause of respiratory failure
Serious comorbidity
Adverse psychological status
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bouchra Lamia, MD, MPH, PhD
Phone
0685426884
Ext
33
Email
bouchra.lamia@chu-rouen.fr
Facility Information:
Facility Name
CH Dieppe
City
Dieppe
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Louis Declercq, MD
Facility Name
CH Elbeuf
City
Elbeuf
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahdi Ould, MD
Facility Name
Le Havre, Jacques Monod Hospital
City
Montivilliers
ZIP/Postal Code
76290
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clement Medrinal
Phone
+33664615110
Email
medrinal.clement.mk@gmail.com
Facility Name
CHU de Rouen
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bouchra Lamia, MD, MPH, PhD
Phone
02 32 88 90 84
Ext
0033
Email
bouchra.lamia@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
Bouchra Lamia, MD, MPH, PhD
12. IPD Sharing Statement
Learn more about this trial
Home Non Invasive Ventilation for COPD Patients
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