High-Flow in Hypercapnic Stable COPD Patients

Adherence, Treatment Clinical Trial

— HIGH-FLOW  

Official title:

Impact of Nasal High Flow (NHF) Versus Home Non-invasive Ventilation (NIV) on Nocturnal Transcutaneous PCO2 (PtCO2) in Stable COPD Patients: A Non-inferiority Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04281316
• Other study ID #: 38R19.250
• Status: Terminated
• Phase: N/A
• Start date: September 23, 2020
• Est. completion date: December 16, 2021

Study information

• Verified date: May 2022
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Chronic obstructive pulmonary disease (COPD) is a growing global health concern, causing considerable health-related costs and increased mortality. COPD is nowadays considered a complex, heterogeneous and systemic condition.

In the late stage of the disease, non-invasive ventilation (NIV) is widely prescribed either to treat acute hypercapnic respiratory failure during COPD exacerbations or for long term home management.

A meta-analysis has shown that higher daytime PaCO2 occurred in home NIV treated COPD patients when NIV compliance is less than 5 h/day. Thus, an optimal NIV adherence is a key target for controlling nocturnal and diurnal hypoventilation and improving prognosis.

COPD is the clinical scenario during which a good NIV adherence is difficult to achieve. Particularly, in COPDs exhibiting hyperinflation, NIV can aggravate dynamic hyperinflation resulting in unrewarded inspiratory efforts, poor sleep and low NIV compliance. Alternatives to NIV are then desirable in this specific subgroup of hypercapnic COPD with poor adherence to NIV.

During this trial, stable COPD patients treated by long term home Non-Invasive Ventilation (NIV) treatment following French national recommendations and exhibiting a NIV compliance of (less than 5 hours and more than 1 hour) per day in the last 3 months prior to inclusion will be randomized via a secure electronic website to either continue with their current NIV treatment or receive the nasal high flow (NHF) treatment delivered by myAirvo2 during 3 months Nasal High-Flow (NHF) is a treatment delivering heated, humidified, and optionally oxygen-enriched air at high flow rates through a nasal cannula. The main physiologic effects of NHF are an improvement in gas exchanges including a reduction in hypercapnia, an optimization in breathing patterns with a reduction of work of breathing. Nasal High-Flow (NHF) is delivered via a comfortable nasal interface and has demonstrated good treatment adherence.

The investigators hypothesize that in COPD-related hypercapnic chronic respiratory failure with limited compliance to NIV (less than 5 hours per night), nasal High-Flow (NHF) will be non-inferior for controlling nocturnal hypoventilation and might improve daytime subjective patients centered outcomes, physical activity and nocturnal adherence to treatment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 16, 2021
• Est. primary completion date: December 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosed with COPD (FEV1/FVC < 70%) and long term indication for home NIV for initiated at least 3 months prior the inclusion.

• Compliance with NIV (less than 5 hours and more than 1 hour) per night on average during the last 3 months prior to inclusion.

• Naïve to Nasal High Flow (NHF) therapy, i.e. having not used NHF in the last 6 months prior to inclusion.

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Adherence, Treatment

Intervention

Device:
• Nasal High Flow installation
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
• Non Invasive Ventilation
Participants randomized in the Non Invasive Ventilation group will receive treatment as in their usual care.

Other:
• Training session
The patients in the Nasal High Flow (MyAirvo) arm will receive two hours training adaptation session in the hospital
• Education session
Participants randomized in the Non Invasive Ventilation group will receive an additional educational session of one hour for improving compliance.

Locations

Country	Name	City	State
France	Grenoble Alpes University Hospital	Grenoble

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Fisher and Paykel Healthcare, Icadom

Country where clinical trial is conducted

France, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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). pii: 180027. doi: 10.1183/16000617.0027-2018. Print 2018 Jun 30. Review. — View Citation

Köhnlein 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. — View Citation

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). pii: 1601731. doi: 10.1183/13993003.01731-2016. Print 2017 Apr. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Maximum PtCO2	between night at day 1 (baseline) and night at day 90 (3 months after)
Secondary	Treatment adherence	Treatment adherence measured objectively by download of NIV software data and for NHF (myAirvo2) by hour meter & daily average of usage (screen display)	between night at day 1 (baseline) and night at day 90 (3 months after)
Secondary	Daytime blood gas values in ambient air	PaCO2 & PaO2 in ambient air will be measured by blood gas sample in NHF group compared de NIV group	between day 0 (inclusion) and day 97 (end of the study)
Secondary	Other nocturnal parameter	Overnight Sp02 will be evaluated by nocturnal oximetry at home in order to determine: mean nocturnal SaO2, nadir nocturnal SaO2, cumulative time spent below 90% of SaO2 (CT<90%), Oxygen Desaturation Index.	between night at day 1 (baseline) and night at day 90 (3 months after)
Secondary	Physical activity	An actimetry will allow evaluating physical activity (number of steps)	for 7 days from the day 1 and for 7 days from the day 90
Secondary	Sleep activity	An actimetry will allow evaluating total sleep time in minutes	between night at day 1 (baseline) and night at day 90 (3 months after)
Secondary	Sleep activity	An actimetry will allow evaluating sleep onset latency in minutes	between night at day 1 (baseline) and night at day 90 (3 months after)
Secondary	Sleep activity	An actimetry will allow evaluating sleep efficiency	between night at day 1 (baseline) and night at day 90 (3 months after)
Secondary	Pulmonary function tests	Pulmonary function will be evaluated by routine patient care spirometry and will measure Vital capacity (VC) in liters	between day 0 and day 97
Secondary	Pulmonary function tests	Pulmonary function will be evaluated by routine patient care spirometry and will measure Forced vital capacity (FVC) in liters	between day 0 and day 97
Secondary	Pulmonary function tests	Pulmonary function will be evaluated by routine patient care spirometry and will measure Forced expiratory volume (FEV) in liters	between day 0 and day 97
Secondary	Health related quality of life	Subjective functioning and quality of life will be measured by self-reporting questionnaire EQ-5D-5L	between day 0 and day 97
Secondary	Health related quality of life	Subjective functioning and quality of life will be measured by self-reporting questionnaire SGRQ	between day 0 and day 97
Secondary	Cardiovasculary function	Blood pressure measurements will be done three times during rest at five minutes intervals to provide informations on systolic, diastolic and mean blood pressure	between day 0 and day 97
Secondary	Number of participants with adverse events will be assessed in each group by interrogating patients in order to assess the safety of nasal high-flow (NHF) treatment	All safety data will be recorded through an Electronic Medical Record as reported by the patient or recorded by the research nurse	between day 0 and day 97