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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01526642
First received: January 23, 2012
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Death [ Time Frame: 1 month and every 6 months during 2 years ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526642

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

No publications provided by University Hospital, Rouen

Additional 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
Study First Received: January 23, 2012
Last Updated: September 5, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on October 20, 2014