Non-invasive Home Ventilation in Patients With Severe Hypercapnic Chronic Obstructive Pulmonary Disease

NCT ID: NCT03934749

Last Updated: 2021-08-09

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-27
• Study Completion Date: 2020-09-27

Brief Summary

In COPD patients with chronic hypercapnic respiratory failure, the prognosis is poor and the treatment with non invasive ventilation is actually well established. However the best mode of ventilation is not well known.

In severe COPD patients various disorders of respiratory mechanics result in insufficient ventilation, which can be life-threatening or create NIV discomfort. The main characteristic of these disorders is a cyclical closing of small airways that can limit an expiratory flow and provoked some fluctuations in flow curve. To our knowledge, the management of dynamic hyperinflation seems to play an important role in explaining the effect of the NIV. Few studies have examined the effects of the machine's adjustments on dynamic hyperinflation.

The main objective of this study is to analyze the impact of specific ventilatory modes supposed to reduce the dynamic hyperinflation on the hematosis, by studying transcutaneous pressure of carbon dioxide, in severe hypercapnic COPD patients ventilated by NIV. Two modes of ventilation will be compared. First one is an algorithmic mode developed by the company Löwenstein (AirTrap Control, Trigger Lockout and the Expiratory Pressure Ramp). The second one is a standard algorithmic mode, used in the same ventilator. These two ventilatory modes will be evaluated in each patient, during two consecutive nights in current living conditions at home.

Conditions

Chronic Obstructive Pulmonary Disease; Hypercapnia

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

standard mode

after adjusting pressure and different modes of ventilation to each individual patient. Each one of them will receive NIV using Löwenstein mode during one night at home. Patients will be under transcutaneous PCO2 measurement and polysomnographic surveillance.

Non Invasive Ventilation

Intervention Type: DEVICE

NIV using standard mode or Lowenstein mode

Lowenstein mode

after adjusting pressure and different modes of ventilation to each individual patient. Each one of them will receive NIV without Löwenstein mode during one night at home. Patients will be under transcutaneous PCO2 measurement and polysomnographic surveillance.

Non Invasive Ventilation

Intervention Type: DEVICE

NIV using standard mode or Lowenstein mode

Interventions

Non Invasive Ventilation

NIV using standard mode or Lowenstein mode

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Diagnosis of COPD using Gold 2017 criterion
• Optimal medical treatment of COPD, ie. inhaled steroids, long-acting β2-agonist, long-acting anticholinergic, according to GOLD 2017 guidelines.
• At least one acute exacerbation of COPD with hypercapnic respiratory failure
• Introduction of NIV distant to acute exacerbation of COPD with persisting hypercapnia (> 7kPa) on arterial blood gas at rest.
• NIV equipment from the service provider "Don Du Souffle (DDS)".
• Patient able to give their consent

Exclusion Criteria

• Contraindication to NIV (consensus conference of SFAR-SPLF-SRLF)
• Obstructive sleep apnea with apnea/hypopnea index > to 20/h
• BMI > 35 kg/m2
• Low compliance with NIV treatment (<3h per day)
• Acute exacerbation COPD during inclusion or pH <7.30 in routine blood gas arterial
• Severe heart failure (New York Heart Association stage IV/IV)
• Unstable angina
• Severe arrhythmias
• Severe renal insufficiency stage > 4
• Other conditions than COPD resulting in hypercapnia
• Pregnancy
• Patient without health insurance
• Patient excluded by another study

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHRU Jean Minjoz

Besançon, Doubs, France

Countries

France

Other Identifiers

2018-A02135-50

Identifier Type: -

Identifier Source: org_study_id