Home Non-invasive Ventilation for Chronic Obstructive Pulmonary Disease Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

— NIVOLD  

Official title:

Home Non-invasive Ventilation Versus Long-term Oxygen Therapy in COPD Survivors of Acute Hypercapnic Respiratory Failure. A Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01526642
• Other study ID #: 2010/080/HP
• Status: Terminated
• Phase: N/A
• First received: January 23, 2012
• Last updated: August 21, 2017
• Start date: December 2011
• Est. completion date: December 2015

Study information

• Verified date: August 2017
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: December 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Hypercapnia
• Hypercapnic Respiratory Failure
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Insufficiency

Intervention

Device:
• Non Invasive Ventilation
NIV during night

Locations

Country	Name	City	State
France	CHU de Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute hypercapnic respiratory failure episode		up to 102 weeks
Secondary	Death		1 month and every 6 months during 2 years