search
Back to results

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
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:

  • 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

First Posted
July 12, 2017
Last Updated
July 19, 2017
Sponsor
University Hospital, Rouen
Collaborators
ADIR Association
search

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

We'll reach out to this number within 24 hrs