NHF vs NIV in Patients With Acute Exacerbation of COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Nasal High Flow Versus Non-Invasive Ventilation in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03466385
• Other study ID #: 48/28-02-2018
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2020
• Source: Evangelismos Hospital
• Contact: Eleni Ischaki, MD, PhD
• Phone: +306974856544
• Email: eischaki[@]yahoo.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Although non-invasive ventilation (NIV) usage has increased significantly over time in COPD exacerbation, a great percentage of patients (~30%) present contraindications to NIV or cannot tolerate it. Nasal high flow (NHF) has been introduced for the management of hypoxemic respiratory failure in adults with favorable effects on ventilation and respiratory mechanics. The above mentioned NHF positive effects has been observed also in stable COPD patients with or without chronic hypercapnia.

In this study, the investigators hypothesize that NHF is not inferior to NIV for respiratory support in patients with COPD exacerbation and acute or acute on chronic hypercapnic respiratory failure.

Description:

The use of non-invasive ventilation (NIV) in COPD exacerbation has increased significantly over time since it has been shown to improve acute respiratory acidosis (increases pH and decreases PaCO2), decrease respiratory rate, work of breathing, severity of breathlessness and therefore reduce mortality and intubation rates.

Despite all these favorable effect, a great percentage of patients (~30%) present contraindications to NIV or cannot tolerate it increasing thus the possibility of NIV failure and consequently intubation rates.

Over the past decade, nasal high flow (NHF) oxygen therapy has been introduced for the management of hypoxemic respiratory failure in adults. NHF can generate high flow rates up to 60 L·min−1 and through this mechanism exerts its positive effects on respiratory mechanics, carbon dioxide washout, patient's respiratory rate and work of breathing. Although the above mentioned NHF positive effects has been observed also in stable COPD patients with or without chronic hypercapnia, NHF use in COPD exacerbation is questionable and only a few case reports studies have been published showing favorable effects of NHF on COPD exacerbation.

In this study, the investigators hypothesize that NHF is not inferior to NIV for respiratory support in patients with COPD exacerbation and acute or acute on chronic hypercapnic respiratory failure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 498
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patient with mild to moderate COPD exacerbation and the following characteristics persisting after initial medical therapy with bronchodilators and controlled oxygen therapy

• 7,25<pH<7,35

• PaCO2>45mmHg

• RR>23

• Ability to obtain written informed consent by the patient or patient's next of kin

Exclusion Criteria:

• severe facial deformity

• Facial burns

• Fixed upper airway obstruction

• Criteria for imminent intubation and invasive mechanical ventilation (any of the following)

• respiratory or cardiac arrest

• gasping respiration

• pH <7.15

• depressed consciousness (Glasgow Coma Score <8)

• psychomotor agitation inadequately controlled by sedation

• massive aspiration

• persistent inability to remove respiratory secretions

• heart rate < 50 ·min-1 with loss of alertness

• severe hemodynamic instability without response to fluids and vasoactive drugs

• severe ventricular arrhythmias

Related Conditions & MeSH terms

• Acute Exacerbation Copd
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Nasal High Flow
Patients admitted to emergency department with COPD exacerbation combined with mild to moderate acute or acute on chronic hypercapnic respiratory failure will be randomized in one of the two study groups. In case of NHF it will be commence immediately with pre-defined settings
• Non-Invasive Ventilation
Patients admitted to emergency department with COPD exacerbation combined with mild to moderate acute or acute on chronic hypercapnic respiratory failure will be randomized in one of the two study groups. In case of NIV it will be commence immediately with pre-defined settings

Locations

Country	Name	City	State
Greece	Evangelismos Hospital	Athens
Greece	Venizeleio Hospital	Heraklion	Crete
Greece	University General Hospital of Larisa	Larisa

Sponsors (4)

Lead Sponsor	Collaborator
Evangelismos Hospital	Larissa University Hospital, Sotiria General Hospital, Venizeleio General Hospital, Heraklion, Crete

Country where clinical trial is conducted

Greece, 

References & Publications (9)

Biselli PJ, Kirkness JP, Grote L, Fricke K, Schwartz AR, Smith P, Schneider H. Nasal high-flow therapy reduces work of breathing compared with oxygen during sleep in COPD and smoking controls: a prospective observational study. J Appl Physiol (1985). 2017 — View Citation

Bräunlich J, Seyfarth HJ, Wirtz H. Nasal High-flow versus non-invasive ventilation in stable hypercapnic COPD: a preliminary report. Multidiscip Respir Med. 2015 Sep 3;10(1):27. doi: 10.1186/s40248-015-0019-y. eCollection 2015. — View Citation

Davidson AC, Banham S, Elliott M, Kennedy D, Gelder C, Glossop A, Church AC, Creagh-Brown B, Dodd JW, Felton T, Foëx B, Mansfield L, McDonnell L, Parker R, Patterson CM, Sovani M, Thomas L; BTS Standards of Care Committee Member, British Thoracic Society/ — View Citation

Fraser JF, Spooner AJ, Dunster KR, Anstey CM, Corley A. Nasal high flow oxygen therapy in patients with COPD reduces respiratory rate and tissue carbon dioxide while increasing tidal and end-expiratory lung volumes: a randomised crossover trial. Thorax. 2 — View Citation

Fricke K, Tatkov S, Domanski U, Franke KJ, Nilius G, Schneider H. Nasal high flow reduces hypercapnia by clearance of anatomical dead space in a COPD patient. Respir Med Case Rep. 2016 Aug 26;19:115-7. doi: 10.1016/j.rmcr.2016.08.010. eCollection 2016. — View Citation

Ischaki E, Pantazopoulos I, Zakynthinos S. Nasal high flow therapy: a novel treatment rather than a more expensive oxygen device. Eur Respir Rev. 2017 Aug 9;26(145). pii: 170028. doi: 10.1183/16000617.0028-2017. Print 2017 Sep 30. Review. — View Citation

Lepere V, Messika J, La Combe B, Ricard JD. High-flow nasal cannula oxygen supply as treatment in hypercapnic respiratory failure. Am J Emerg Med. 2016 Sep;34(9):1914.e1-2. doi: 10.1016/j.ajem.2016.02.020. Epub 2016 Feb 12. — View Citation

Mauri T, Turrini C, Eronia N, Grasselli G, Volta CA, Bellani G, Pesenti A. Physiologic Effects of High-Flow Nasal Cannula in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2017 May 1;195(9):1207-1215. doi: 10.1164/rccm.201605-0916OC. — View Citation

Pisani L, Fasano L, Corcione N, Comellini V, Musti MA, Brandao M, Bottone D, Calderini E, Navalesi P, Nava S. Change in pulmonary mechanics and the effect on breathing pattern of high flow oxygen therapy in stable hypercapnic COPD. Thorax. 2017 Apr;72(4): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of treatment failure	As treatment failure is defined any need to switch to other treatment group because of discomfort, intolerance or failure to improve physiologic parameters (especially respiratory rate and ABG) despite optimum settings	The first assessment will be held at 2 hours
Secondary	Changes on respiratory rate	This secondary outcome includes changes on respiratory rate (breaths per minute)	They will be assessed on baseline, before NIV or NHF initiation, and on 1, 2, 4, 6, 12, 24, 48 hours and once daily after day 3.
Secondary	Changes on arterial partial pressure of oxygen	This secondary outcome includes changes on arterial partial pressure of oxygen values (unit of measure will be mmHg)	They will be assessed on baseline, before NIV or NHF initiation, and on 1, 2, 4, 6, 12, 24, 48 hours and once daily after day 3.
Secondary	Changes on arterial partial pressure of carbon dioxide	This secondary outcome includes changes on arterial partial pressure of carbon dioxide (unit of measure will be mmHg)	They will be assessed on baseline, before NIV or NHF initiation, and on 1, 2, 4, 6, 12, 24, 48 hours and once daily after day 3.
Secondary	Changes on arterial pH	This secondary outcome includes changes on arterial pH values	They will be assessed on baseline, before NIV or NHF initiation, and on 1, 2, 4, 6, 12, 24, 48 hours and once daily after day 3.
Secondary	Changes on respiratory accessory muscle use	This secondary outcome includes recording of respiratory accessory muscle use (recording will be yes or no)	They will be assessed on baseline, before NIV or NHF initiation, and on 1, 2, 4, 6, 12, 24, 48 hours and once daily after day 3.
Secondary	Patient's dyspnea	Dyspnea will be assessed with a 10-point visual analog scale and also Borg scale for dyspnea	They will be assessed on baseline, before NIV or NHF initiation, and on 1, 2, 4, 6, 12, 24, 48 hours and once daily after day 3 (in those subjects whose neurological status allowed them to complete the evaluation)
Secondary	Pulmonary complications	Any pulmonary complication will be assessed and correlated with the allocated treatment	They will be assessed on baseline, before NIV or NHF initiation, and on 1, 2, 4, 6, 12, 24, 48 hours and once daily after day 3.
Secondary	Extrapulmonary complications	Any extrapulmonary complication will be assessed and correlated with the allocated treatment	They will be assessed on baseline, before NIV or NHF initiation, and on 1, 2, 4, 6, 12, 24, 48 hours and once daily after day 3