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

NCT03934749 | Terminated

• 1 other identifier: 2018-A02135-50
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Mean carbon dioxide partial pressure-level during non invasive ventilation

  Mean pCO2 level over night calculated using transcutaneous measurement of partial pressure of carbon dioxide under non invasive ventilation. Device : transcutaneous capnography (PtcCO2); SenTec Digital Monitoring System

  2 nights

Secondary Outcomes (3)

• Number of respiratory events during non invasive ventilation

  2 nights

• Sleep quality

  2 nights

• Ventilation quality

  2 nights

Study Arms (2)

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.

Device: Non Invasive Ventilation

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.

Device: Non Invasive Ventilation

Interventions

Non Invasive Ventilation DEVICE

NIV using standard mode or Lowenstein mode

Lowenstein mode; standard mode

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients followed in the pneumology department of the Besançon university hospital.

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHRU Jean Minjoz

Besançon, Doubs, 25000, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypercapnia

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 2, 2019
• Study Start: June 27, 2019
• Primary Completion: June 27, 2020
• Study Completion: September 27, 2020
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)