Innovation in NOn Invasive Ventilation in COPD Patients Treated by Long Term Oxygen Therapy

Not Applicable

Terminated

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Device: NIV Device + LTOT; Device: LTOT

• Registration Number: NCT03584269
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

The aim of this study is to investigate the efficacy of non-invasive ventilation (NIV) on nocturnal hypoventilation in patients with chronic obstructive pulmonary disease (COPD) who are on long term oxygen therapy (LTOT) at home.

Detailed Description

This is a prospective, randomized, open labelled study. The primary outcome is nocturnal transcutaneous CO2 (PtCO2) after 3 months of non-invasive ventilation. Three hundred COPD patients on LTOT will be screened and assessed by pulmonary function tests, blood gases and nocturnal PtCO2 at their home. This will allow the determination of the prevalence of nocturnal hypoventilation in COPD patients on LTOT (a secondary outcome) and to select patients who meet the inclusion criteria for the RCT and randomization to NIV + LTOT or to continue LTOT alone (n=38). Patients will undergo the same assessments at the end of the three-month intervention period.

Study Timeline

• Study First Submitted: 2018-01-22
• Study Start: 2018-06-28
• Primary Completion: 2018-07-09
• Study First Submitted QC: 2018-07-10
• Study First Posted: 2018-07-12
• Study Completion: 2019-09-23
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• chronic obstructive pulmonary disease (COPD)

  • on long term oxygen therapy (LTOT)
  • affiliated to French social security system or equivalent
  • informed consent signed

Exclusion Criteria

• Diurnal PtCO2 >55mmHg
• Patient who has had an exacerbation of COPD requiring a change in management or treatment in the last 4 weeks prior to the inclusion visit.
• Pregnant or breathfeeding women
• Prisonners or persons who require protection by the law
• Exclusion period from another study
• Persons who, according to the investigator, are expected no to meet all study obligations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIV Device + LTOT	NIV Device + LTOT	administration of ventilary support, without using an invasive artificial airway
LTOT	LTOT	standard treatment, without NIV

Primary Outcome Measures

Name	Time	Method
Nocturnal transcutaneous pressure CO2 (PtCO2)	3 months	Measurement of nocturnal PtCO2 using the SenTec system

Secondary Outcome Measures

Name	Time	Method
Vital capacity	3 months	Pulmonary function tests
Saint George's Respiratory Questionnaire	3 months	Measure of quality of life
PaO2	3 months	Blood gases
SaO2	3 months	Physiological responses during the Semi paced 3-min Chair rise test
Dyspnea score	3 months	Symptoms during the Semi paced 3-min Chair rise test
Fasting Glucose	3 months	Biological parameters
CRPus	3 months	Biological parameters
PaCO2	3 months	Blood gases
Energy expenditure	3 months	Physical activity measured at home (one week)
Heart Rate	3 months	Physiological responses during the Semi paced 3-min Chair rise test
Fatigue score	3 months	Symptoms during the Semi paced 3-min Chair rise test
FEV1	3 months	Pulmonary function tests
Time in supine and sitting positions	3 months	Physical activity measured at home (one week)
Steps per day	3 months	Physical activity measured at home (one week)
Cholesterol	3 months	Biological parameters
Triglycerides	3 months	Biological parameters
HBA1c	3 months	Biological parameters

Trial Locations

Locations (1)

University Hospital Grenoble; 🇫🇷 La Tronche, France