Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
498 participants
INTERVENTIONAL
2018-04-15
2021-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Nasal High Flow Versus Non-invasive Ventilation for Early Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Hypercapnic Acidosis
NCT06114667
Home Non Invasive Ventilation (NIV) Treatment for COPD-patients After a NIV-treated Exacerbation
NCT01513655
Comparison of HFNC With NIV in Weaning COPD
NCT03458364
High Flow Nasal Therapy Versus Noninvasive Ventilation in COPD Exacerbation
NCT03370666
High Flow Nasal Cannula vs NPPV in Moderate Chronic Obstructive Pulmonary Disease Exacerbation
NCT03014869
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nasal High Flow
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%.
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 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%.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
40 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Venizeleio General Hospital, Heraklion, Crete
UNKNOWN
Larissa University Hospital
OTHER
Sotiria General Hospital
OTHER
Evangelismos Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
ISCHAKI ELENI
Consultant, ICU Department
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Spyros Zakynthinos, MD, PhD, FCCP
Role: PRINCIPAL_INVESTIGATOR
Evangelismos Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Venizeleio Hospital
Heraklion, Crete, Greece
Evangelismos Hospital
Athens, , Greece
University General Hospital of Larisa
Larissa, , Greece
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
48/28-02-2018
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.