Chronic Obstructive Pulmonary DiseaseNCT03466385
NHF vs NIV in Patients With Acute Exacerbation of COPD
A study testing Nasal High Flow and Non-Invasive Ventilation in people with Chronic Obstructive Pulmonary Disease and Respiratory Failure, run by Evangelismos Hospital at 3 sites in Greece.
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Respiratory Failure, Acute Exacerbation Copd
- What is being tested?
- Nasal High Flow and Non-Invasive Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 498 participants
- Where
- 3 sitesGreece
- Study dates
- 15 Apr 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Greece3 sites, 3 recruiting
- Recruiting
Evangelismos Hospital
Athens, 10673
Eleni Ischaki, +306974856544, eischaki@yahoo.gr
- Recruiting
Venizeleio Hospital
Heraklion, Crete, 71409
Ioannis Pantazopoulos, +306945661525, pantazopoulosioannis@yahoo.com
- Recruiting
University General Hospital of Larisa
Larissa, 41110
Stratos Manoulakas, stratosfox@hotmail.com
About this study
Official title: Nasal High Flow Versus Non-Invasive Ventilation in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
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.
Read the detailed 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.
- Being tested
- Nasal High Flow, Non-Invasive Ventilation
- Keywords
- Non-invasive ventilation, Nasal High Flow
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal High FlowDevice
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 VentilationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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%. Receives: 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%. Receives: Device: Non-Invasive Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The first assessment will be held at 2 hours
Secondary outcomes (8)
Changes on respiratory rate
This secondary outcome includes changes on respiratory rate (breaths per minute)
Measured: 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
This secondary outcome includes changes on arterial partial pressure of oxygen values (unit of measure will be mmHg)
Measured: 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
This secondary outcome includes changes on arterial partial pressure of carbon dioxide (unit of measure will be mmHg)
Measured: 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
This secondary outcome includes changes on arterial pH values
Measured: 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
This secondary outcome includes recording of respiratory accessory muscle use (recording will be yes or no)
Measured: 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.
Patient's dyspnea
Dyspnea will be assessed with a 10-point visual analog scale and also Borg scale for dyspnea
Measured: 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)
Pulmonary complications
Any pulmonary complication will be assessed and correlated with the allocated treatment
Measured: 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.
Extrapulmonary complications
Any extrapulmonary complication will be assessed and correlated with the allocated treatment
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start15 Apr 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 498 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evangelismos Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Venizeleio General Hospital, Heraklion, Crete, Larissa University Hospital, Sotiria General Hospital
- Responsible party
- Principal investigator, ISCHAKI ELENI, Evangelismos Hospital
- Investigators
- Spyros Zakynthinos, MD, PhD, FCCP, Principal investigator, Evangelismos Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466385
- Sponsor's protocol ID
- 48/28-02-2018
- Status last verified
- Feb 2020
- First submitted
- 28 Feb 2018
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information that are planned to be shared re study protocol, statistical analysis and clinical study report. They will be shared after 3 months of study publication to anyone who is interested in writing a meta-analysis or review
Publications
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.
PubMed 26976648Ischaki 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.
PubMed 28794144Mauri 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.
PubMed 27997805Fricke 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.
PubMed 27668173Biselli 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.
PubMed 27815367Braunlich 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.
PubMed 26339486Fraser 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.
PubMed 27015801Pisani 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.
PubMed 28104830Lepere 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.
PubMed 26947372Pantazopoulos 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.
PubMed 39111544
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal High Flow Versus Non-Invasive Ventilation in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03466385
- Acronym / sponsor ID
- 48/28-02-2018
- Keywords
- Non-invasive ventilation, Nasal High Flow
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 498 participants (estimated)
- Lead sponsor
- Evangelismos HospitalUniversity, hospital or other
- Collaborators
- Venizeleio General Hospital, Heraklion, Crete, Larissa University Hospital, Sotiria General Hospital
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 15 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal High Flow | Experimental | Device: Nasal High FlowPatients 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%. |
| Non-Invasive Ventilation | Active comparator | Device: Non-Invasive VentilationPatients 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%. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with mild to moderate COPD exacerbation and the following characteristics persisting after initial medical therapy with bronchodilators and controlled oxygen therapy
- Ability to obtain written informed consent by the patient or patient's next of kin
Key exclusion criteria (14 listed)
- severe facial deformity
- Facial burns
- Fixed upper airway obstruction
- Criteria for imminent intubation and invasive mechanical ventilation (any of the following)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal High FlowPatients 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 | Device | Nasal High Flow |
| Non-Invasive VentilationPatients 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 | Device | Non-Invasive Ventilation |
Primary outcome
Frequency of treatment failure
Time frame: The first assessment will be held at 2 hours
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
8 secondary outcomes
Changes on respiratory rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Patient's dyspnea
Time frame: 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)
Pulmonary complications
Time frame: 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.
Extrapulmonary complications
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Results publication: PubMed 26976648Davidson 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.
- Results publication: PubMed 28794144Ischaki 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.
- Results publication: PubMed 27997805Mauri 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.
- Results publication: PubMed 27668173Fricke 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.
- Results publication: PubMed 27815367Biselli 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.
- Results publication: PubMed 26339486Braunlich 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.
- Results publication: PubMed 27015801Fraser 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.
- Results publication: PubMed 28104830Pisani 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.
- Results publication: PubMed 26947372Lepere 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.
- Derived from this study: PubMed 39111544Pantazopoulos 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.
- Individual participant dataSharing planned: Yes. Information that are planned to be shared re study protocol, statistical analysis and clinical study report. They will be shared after 3 months of study publication to anyone who is interested in writing a meta-analysis or review
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Spyros Zakynthinos, MD, PhD, FCCP principal investigator
Evangelismos Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal High Flow and Non-Invasive Ventilation in people with Chronic Obstructive Pulmonary Disease and Respiratory Failure, run by Evangelismos Hospital at 3 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eleni Ischaki, MD, PhD (+306974856544, eischaki@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of treatment failure (time frame: The first assessment will be held at 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03466385, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.