COPD (Chronic Obstructive Pulmonary Disease)NCT07854210
HFNC Versus NIV in Hypercapneic COPD Patients
A study testing high flow nasal cannula and non invasive ventilation in people with COPD (Chronic Obstructive Pulmonary Disease), run by Mohammed Shehta at 1 site in Egypt.
Trial summary
Aim: To compare gas exchange trends, clinical outcomes, and tolerability between HFNC and NIV in COPD patients with mild-to-moderate hypercapnic respiratory failure. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- high flow nasal cannula and non invasive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Nov 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD patients hospitalized with mild-to-moderate hypercapnic respiratory failure, defined as arterial pH [range, e.g., 7.25-7.35] and PaCO2 [threshold, e.g., >45 mmHg and less 60 mmHg].
Who cannot join
- patients with altered mental state, confused, severe agitation or not cooperative were excluded. Also, severe acidosis (pH <7.25), hemodynamic instability, facial trauma or surgery, cases with severe nasal deformity, immediate indication for invasive ventilation, patient refusal, cases with respiratory rate more than 35 breaths per minute. Respiratory exhaustion, excess use of respiratory accessory muscles, Patients with breathing disorders during sleep as well as cases of upper airway obstruction and patients with history of chronic home ventilation prior admission were another items for exclusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Mansoura University
Al Mansurah, Dakahlia Governorate, 35516
Mohammed Shehta, dr_mshehta@mans.edu.eg
About this study
Official title: Gas Exchange, Clinical Outcomes, and Tolerability of High-Flow Nasal Cannula Versus Non-Invasive Ventilation in COPD Patients With Mild-to-Moderate Hypercapnic Respiratory Failure
Aim: To compare gas exchange trends, clinical outcomes, and tolerability between HFNC and NIV in COPD patients with mild-to-moderate hypercapnic respiratory failure.
- Being tested
- high flow nasal cannula, non invasive ventilation
- Keywords
- COPD, Hypecapneic respiratory failure, HFNC, NIV
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high flow nasal cannulaDevice
high flow nasal canula oxygen therapy according to study protocol
non invasive ventilationDevice
non invasive ventilation according to study protocol
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: high flow nasal canula | Experimental | patients recieve high flow nasal canula oxygen therapy according to study protocol Receives: Device: high flow nasal cannula |
| Arm 2: non invasive ventilation (NIV) | Active comparator | patients recieve NIV according to study protocol Receives: Device: non invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment failure
treatment failure defined as the need for escalation from assigned respiratory support to a higher level of ventilatory support during hospitalization. In HFNC group, treatment failure is defined as the need for rescue NIV or invasive mechanical ventilation. In the NIV group ,treatment failure is defined as the need of invasive mechanical ventilation.
( number and percentages of patients experiencing treatment failure in each treatment group)
Measured: From initiation of the assigned respiratory support until hospital discharge, assessed throughout the hospitalization (up to 30 days).
Secondary outcomes (1)
serial arterial blood gas parameters at 12, 24 and 48 hours
serial arterial blood gas parameters (pH, PaCO2, HCO3) at 12, 24 and 48 hours;
Measured: at 12, 24, 48 hours after start of respiratory support
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start3 Nov 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohammed Shehta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammed Shehta, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854210
- Sponsor's protocol ID
- MFM-IRB R.25.09.3356
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gas Exchange, Clinical Outcomes, and Tolerability of High-Flow Nasal Cannula Versus Non-Invasive Ventilation in COPD Patients With Mild-to-Moderate Hypercapnic Respiratory Failure
- ClinicalTrials.gov ID
- NCT07854210
- Acronym / sponsor ID
- MFM-IRB R.25.09.3356
- Keywords
- COPD, Hypecapneic respiratory failure, HFNC, NIV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Mohammed ShehtaUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Oct 2026 (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.
Aim: To compare gas exchange trends, clinical outcomes, and tolerability between HFNC and NIV in COPD patients with mild-to-moderate hypercapnic respiratory failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: high flow nasal canula | Experimental | Device: high flow nasal cannulapatients recieve high flow nasal canula oxygen therapy according to study protocol |
| Arm 2: non invasive ventilation (NIV) | Active comparator | Device: non invasive ventilationpatients recieve NIV according to study protocol |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COPD patients hospitalized with mild-to-moderate hypercapnic respiratory failure, defined as arterial pH [range, e.g., 7.25-7.35] and PaCO2 [threshold, e.g., >45 mmHg and less 60 mmHg].
Key exclusion criteria (1 listed)
- patients with altered mental state, confused, severe agitation or not cooperative were excluded. Also, severe acidosis (pH <7.25), hemodynamic instability, facial trauma or surgery, cases with severe nasal deformity, immediate indication for invasive ventilation, patient refusal, cases with respiratory rate more than 35 breaths per minute. Respiratory exhaustion, excess use of respiratory accessory muscles, Patients with breathing disorders during sleep as well as cases of upper airway obstruction and patients with history of chronic home ventilation prior admission were another items for exclusion
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 |
|---|---|---|
| high flow nasal cannulahigh flow nasal canula oxygen therapy according to study protocol | Device | Arm 1: high flow nasal canula |
| non invasive ventilationnon invasive ventilation according to study protocol | Device | Arm 2: non invasive ventilation (NIV) |
Primary outcome
treatment failure
Time frame: From initiation of the assigned respiratory support until hospital discharge, assessed throughout the hospitalization (up to 30 days).
treatment failure defined as the need for escalation from assigned respiratory support to a higher level of ventilatory support during hospitalization. In HFNC group, treatment failure is defined as the need for rescue NIV or invasive mechanical ventilation. In the NIV group ,treatment failure is defined as the need of invasive mechanical ventilation. ( number and percentages of patients experiencing treatment failure in each treatment group)
1 secondary outcome
serial arterial blood gas parameters at 12, 24 and 48 hours
Time frame: at 12, 24, 48 hours after start of respiratory support
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high flow nasal cannula and non invasive ventilation in people with COPD (Chronic Obstructive Pulmonary Disease), run by Mohammed Shehta at 1 site in Egypt.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Shehta, associate professor-chest med. (01004344106, dr_mshehta@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment failure (time frame: From initiation of the assigned respiratory support until hospital discharge, assessed throughout the hospitalization (up to 30 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2026.