NHF vs NIV in Patients With Acute Exacerbation of COPD

NCT03466385 | Unknown DMC

• 1 other identifier: 48/28-02-2018
• Study Type: interventional
• Target: 498
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease; Respiratory Failure; Acute Exacerbation Copd

Keywords

Non-invasive ventilation; Nasal High Flow

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Changes on respiratory rate

  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.

• Changes on arterial partial pressure of oxygen

  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.

• Changes on arterial partial pressure of carbon dioxide

  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.

• Changes on arterial pH

  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.

• Changes on respiratory accessory muscle use

  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.

Study Arms (2)

Nasal High Flow

EXPERIMENTAL

Patients randomized to NHF device with initial settings of flow=50-60 L·min-1, temperature=37ο Celsius and FiO2 adjusted to maintain SpO2 between 88%-92%.

Device: Nasal High Flow

Non-Invasive Ventilation

ACTIVE COMPARATOR

Patients randomized to NIV with initial settings EPAP=3cmH2O, IPAP=15cmH2O, I:E=1:2 to 1:3, inspiratory time=0.8-1.2sec and FiO2 adjusted to maintain SpO2 between 88%-92%.

Device: Non-Invasive Ventilation

Interventions

Nasal High Flow DEVICE

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

Nasal High Flow

Non-Invasive Ventilation DEVICE

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

Non-Invasive Ventilation

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with mild to moderate COPD exacerbation and the following characteristics persisting after initial medical therapy with bronchodilators and controlled oxygen therapy
• ,25\<pH\<7,35
• PaCO2\>45mmHg
• RR\>23
• Ability to obtain written informed consent by the patient or patient's next of kin

You may not qualify if:

• 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

Sponsors & Collaborators

• Evangelismos Hospital: lead
• Venizeleio General Hospital, Heraklion, Crete: collaborator
• Larissa University Hospital: collaborator
• Sotiria General Hospital: collaborator

Study Sites (3)

Venizeleio Hospital

Heraklion, Crete, 71409, Greece

RECRUITING

Evangelismos Hospital

Athens, 10673, Greece

RECRUITING

University General Hospital of Larisa

Larissa, 41110, Greece

RECRUITING

Related Publications (10)

• Davidson AC, Banham S, Elliott M, Kennedy D, Gelder C, Glossop A, Church AC, Creagh-Brown B, Dodd JW, Felton T, Foex B, Mansfield L, McDonnell L, Parker R, Patterson CM, Sovani M, Thomas L; BTS Standards of Care Committee Member, British Thoracic Society/Intensive Care Society Acute Hypercapnic Respiratory Failure Guideline Development Group, On behalf of the British Thoracic Society Standards of Care Committee. BTS/ICS guideline for the ventilatory management of acute hypercapnic respiratory failure in adults. Thorax. 2016 Apr;71 Suppl 2:ii1-35. doi: 10.1136/thoraxjnl-2015-208209. No abstract available.

  PMID: 26976648 RESULT

• 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):170028. doi: 10.1183/16000617.0028-2017. Print 2017 Sep 30.

  PMID: 28794144 RESULT

• 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.

  PMID: 27997805 RESULT

• 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.

  PMID: 27668173 RESULT

• 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 Jan 1;122(1):82-88. doi: 10.1152/japplphysiol.00279.2016. Epub 2016 Nov 4.

  PMID: 27815367 RESULT

• Braunlich 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.

  PMID: 26339486 RESULT

• 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. 2016 Aug;71(8):759-61. doi: 10.1136/thoraxjnl-2015-207962. Epub 2016 Mar 25.

  PMID: 27015801 RESULT

• 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):373-375. doi: 10.1136/thoraxjnl-2016-209673. Epub 2017 Jan 19.

  PMID: 28104830 RESULT

• 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. No abstract available.

  PMID: 26947372 RESULT

• Pantazopoulos I, Boutlas S, Mavrovounis G, Papalampidou A, Papagiannakis N, Kontou M, Bibaki E, Athanasiou N, Meletis G, Gourgoulianis K, Zakynthinos S, Ischaki E. Nasal high flow or noninvasive ventilation? navigating hypercapnic COPD exacerbation treatment: A randomized noninferiority clinical trial. Respir Med. 2024 Oct;232:107762. doi: 10.1016/j.rmed.2024.107762. Epub 2024 Aug 5.

  PMID: 39111544 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

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

• Spyros Zakynthinos, MD, PhD, FCCP

  Evangelismos Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eleni Ischaki, MD, PhD

CONTACT

+306974856544; eischaki@yahoo.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, ICU Department

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 15, 2018
• Study Start: April 15, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 3 months after publication
• Access Criteria: To anyone who is interested in writing a meta-analysis or review

Locations

GR (3)