Innovation in NOn Invasive Ventilation in COPD Patients Treated by Long Term Oxygen Therapy (INOV-LTOT)

Grenoble Alpes University Hospital Center (CHU)

Status: Terminated

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Device: LTOT; Device: NIV Device + LTOT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03584269

38RC17.117

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

45 participants in 2 patient groups

NIV Device + LTOT

Experimental group

Description:

administration of ventilary support, without using an invasive artificial airway

Treatment:

Device: NIV Device + LTOT

LTOT

Active Comparator group

Description:

standard treatment, without NIV

Treatment:

Device: LTOT