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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01526642
Recruitment Status : Terminated
First Posted : February 6, 2012
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Hypercapnic Respiratory Failure Device: Non Invasive Ventilation

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2011
Primary Completion Date : December 2013
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Long Term Oxygen Therapy
Active Comparator: Non Invasive Ventilation Device: Non Invasive Ventilation
NIV during night


Outcome Measures

Primary Outcome Measures :
  1. Acute hypercapnic respiratory failure episode [ Time Frame: up to 102 weeks ]

Secondary Outcome Measures :
  1. Death [ Time Frame: 1 month and every 6 months during 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01526642


Locations
France
CHU de Rouen
Rouen, France, 76000
Sponsors and Collaborators
University Hospital, Rouen
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01526642     History of Changes
Other Study ID Numbers: 2010/080/HP
First Posted: February 6, 2012    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Insufficiency
Hypercapnia
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms