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

This study has been terminated.
Information provided by (Responsible Party):
University Hospital, Rouen Identifier:
First received: January 23, 2012
Last updated: September 5, 2014
Last verified: September 2014
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 Intervention Phase
Chronic Obstructive Pulmonary Disease Hypercapnic Respiratory Failure Device: Non Invasive Ventilation- Device is: VPAP ST (Resmed, Australia) Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by University Hospital, Rouen:

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

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

Enrollment: 12
Study Start Date: December 2011
Study Completion Date: December 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Long Term Oxygen Therapy
Active Comparator: Non Invasive Ventilation Device: Non Invasive Ventilation- Device is: VPAP ST (Resmed, Australia)
NIV during night


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

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
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Please refer to this study by its identifier: NCT01526642

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Hospital, Rouen Identifier: NCT01526642     History of Changes
Other Study ID Numbers: 2010/080/HP
Study First Received: January 23, 2012
Last Updated: September 5, 2014

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Insufficiency
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms processed this record on August 16, 2017