High-Flow in Hypercapnic Stable COPD Patients

NCT04281316 | Terminated

• 1 other identifier: 38R19.250
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Monocentric, prospective, open, randomized 1:1, controlled study to evaluate the impact of nasal high-flow (NHF) on nocturnal transcutaneous PCO2 (PtCO2) compared to non-invasive ventilation ± Long-Term Oxygen Therapy (LTOT) in patients with a Chronic obstructive pulmonary disease (COPD)-related hypercapnic respiratory failure.

Conditions

Adherence, Treatment

Keywords

non-compliance; NIV; NHF; COPD; hypercapnic respiratory failure

Outcome Measures

Primary Outcomes (1)

• Changes on nocturnal parameters with the nasal high-flow (NHF) compared to non-invasive ventilation in patients with a COPD-related hypercapnic respiratory failure.

  Differences in mean overnight transcutaneous PtCO2 measurement

  between night at day 1 (baseline) and night at day 90 (3 months after)

Secondary Outcomes (15)

• Evaluation the impact of nasal high-flow (NHF) on other nocturnal parameters compared to non-invasive ventilation ± LTOT compared to non-invasive ventilation in patients with a COPD-related hypercapnic respiratory failure.

  between night at day 1 (baseline) and night at day 90 (3 months after)

• Treatment adherence

  between night at day 1 (baseline) and night at day 90 (3 months after)

• Daytime blood gas values in ambient air

  between day 0 (inclusion) and day 97 (end of the study)

• Other nocturnal parameter

  between night at day 1 (baseline) and night at day 90 (3 months after)

• Physical activity

  for 7 days from the day 1 and for 7 days from the day 90

Study Arms (2)

Non Invasive Ventilation device group

ACTIVE COMPARATOR

The patients in the NIV arm will receive treatment as in their usual care with an additional educational session of one hour for improving compliance.

Device: Non Invasive Ventilation; Other: Education session

Nasal High Flow (MyAirvo) device group

EXPERIMENTAL

The patients in the NHF arm will receive NHF treatment and two hours training adaptation session will be conducted in the hospital.

Device: Nasal High Flow installation; Other: Training session

Interventions

Nasal High Flow installation DEVICE

Participants randomized in NHF group will receive the nasal high flow (NHF) treatment delivered by myAirvo2. Nasal High-Flow (NHF) is a treatment delivering heated, humidified, and optionally oxygen-enriched, air at high flow rates through a nasal cannula. The physiologic effects of NHF are an improvement in gas exchanges including a reduction in hypercarbia an optimization in breathing patterns with a reduction of work of breathing and high compliance as delivered via a comfortable nasal interface

Also known as: MyAirvo Device

Nasal High Flow (MyAirvo) device group

Non Invasive Ventilation DEVICE

Participants randomized in the Non Invasive Ventilation group will receive treatment as in their usual care.

Non Invasive Ventilation device group

Training session OTHER

The patients in the Nasal High Flow (MyAirvo) arm will receive two hours training adaptation session in the hospital

Nasal High Flow (MyAirvo) device group

Education session OTHER

Participants randomized in the Non Invasive Ventilation group will receive an additional educational session of one hour for improving compliance.

Non Invasive Ventilation device group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand, follow objectives and methods of protocol in French language.
• Patient affiliated to social security insurance or beneficiary of social health insurance.
• Willing and able to give written Informed Consent and to comply with the requirements of the study protocol.

You may not qualify if:

• Significant uncontrolled cardiac disease (investigator judgment), and/or Left Ventricular Ejection Fraction (LVEF) \< 45%.
• Known co-existing obstructive sleep apnea requiring expiratory pressure above 6 cmH20.
• Severe nasal obstruction, previous upper airway surgery preventing the usage of NHF, or, at the discretion of investigator, any other contraindication for using the NHF.
• Patients who are unable or unwilling to give informed consent.
• Participating in another research study.
• Patient protected by the Law, under guardianship or curators.
• Pregnancy and nursing mothers
• Patient not covered by a health insurance.

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Icadom: collaborator
• Fisher and Paykel Healthcare: collaborator

Study Sites (1)

Grenoble Alpes University Hospital

Grenoble, France

Location

Related Publications (10)

• Biener AI, Decker SL, Rohde F. Prevalence and Treatment of Chronic Obstructive Pulmonary Disease (COPD) in the United States. JAMA. 2019 Aug 20;322(7):602. doi: 10.1001/jama.2019.10241. No abstract available.

  PMID: 31429884 BACKGROUND

• Riley CM, Sciurba FC. Diagnosis and Outpatient Management of Chronic Obstructive Pulmonary Disease: A Review. JAMA. 2019 Feb 26;321(8):786-797. doi: 10.1001/jama.2019.0131.

  PMID: 30806700 BACKGROUND

• Houben-Wilke S, Augustin IM, Vercoulen JH, van Ranst D, Bij de Vaate E, Wempe JB, Spruit MA, Wouters EFM, Franssen FME. COPD stands for complex obstructive pulmonary disease. Eur Respir Rev. 2018 Jun 6;27(148):180027. doi: 10.1183/16000617.0027-2018. Print 2018 Jun 30.

  PMID: 29875138 BACKGROUND

• Suh ES, Murphy PB, Hart N. Home mechanical ventilation for chronic obstructive pulmonary disease: What next after the HOT-HMV trial? Respirology. 2019 Aug;24(8):732-739. doi: 10.1111/resp.13484. Epub 2019 Feb 7.

  PMID: 30729638 BACKGROUND

• Crimi C, Noto A, Princi P, Cuvelier A, Masa JF, Simonds A, Elliott MW, Wijkstra P, Windisch W, Nava S. Domiciliary Non-invasive Ventilation in COPD: An International Survey of Indications and Practices. COPD. 2016 Aug;13(4):483-90. doi: 10.3109/15412555.2015.1108960. Epub 2016 Jan 8.

  PMID: 26744042 BACKGROUND

• Kohnlein T, Windisch W, Wegscheider K, Welte T. Non-invasive positive pressure ventilation for severe COPD--Authors' reply. Lancet Respir Med. 2014 Oct;2(10):e19. doi: 10.1016/S2213-2600(14)70215-2. No abstract available.

  PMID: 25298063 BACKGROUND

• Murphy AM, Thomas A, Crinion SJ, Kent BD, Tambuwala MM, Fabre A, Pepin JL, Roche HM, Arnaud C, Ryan S. Intermittent hypoxia in obstructive sleep apnoea mediates insulin resistance through adipose tissue inflammation. Eur Respir J. 2017 Apr 19;49(4):1601731. doi: 10.1183/13993003.01731-2016. Print 2017 Apr.

  PMID: 28424360 BACKGROUND

• Vanfleteren LEGW, Spruit MA, Wouters EFM, Franssen FME. Management of chronic obstructive pulmonary disease beyond the lungs. Lancet Respir Med. 2016 Nov;4(11):911-924. doi: 10.1016/S2213-2600(16)00097-7. Epub 2016 Jun 2.

  PMID: 27264777 BACKGROUND

• Borel JC, Pepin JL, Pison C, Vesin A, Gonzalez-Bermejo J, Court-Fortune I, Timsit JF. Long-term adherence with non-invasive ventilation improves prognosis in obese COPD patients. Respirology. 2014 Aug;19(6):857-65. doi: 10.1111/resp.12327. Epub 2014 Jun 9.

  PMID: 24912564 BACKGROUND

• Struik FM, Lacasse Y, Goldstein RS, Kerstjens HA, Wijkstra PJ. Nocturnal noninvasive positive pressure ventilation in stable COPD: a systematic review and individual patient data meta-analysis. Respir Med. 2014 Feb;108(2):329-37. doi: 10.1016/j.rmed.2013.10.007. Epub 2013 Oct 14.

  PMID: 24157199 BACKGROUND

MeSH Terms

Conditions

Treatment Adherence and Compliance; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Jean-Louis Pépin, MD PhD

  Laboratoire EFCR, CHU de Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 24, 2020
• Study Start: September 23, 2020
• Primary Completion: December 16, 2021
• Study Completion: December 16, 2021
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)