Respiratory FailureNCT07521254
Noninvasive Technique and High Flow Nasal Oxygen in Respiratory Failure
A study testing HFNC and NIV in people with Respiratory Failure, run by Minia University at 1 site in Egypt.
Trial summary
After obtaining Institutional Ethical Committee approval of Faculty of Medicine, Minia University and written informed consent from patients or first- degree relatives, this prospective randomized non-blind comparative study will be conducted in adult intensive care unit (ICU) of Anesthesia, Intensive Care and Pain… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- HFNC and NIV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 year of both sexes. • Diagnosed with Acute Respiratory Failure (ARF) defined as the combination of a PaO2/FiO2 ratio < 300 after 15 minutes of conventional oxygen delivered through a face mask, with a FiO2 at least of 50% and respiratory rate > 30 breaths/min.
Who cannot join
- Chronic respiratory disease
- Cardiogenic pulmonary edema
- Life-threatening arrythmias
- Hemodynamic instability requiring vasopressors
- Facial abnormalities preventing NIV or HFNC application
- Glasgow coma score of ≤ 12 points (Teasdale et al. 1974)
Show all 9Show fewer
- Agitated patients characterized by RASS score (Richmond Agitation Sedation Scale) ≥ +2
- Patients who needed immediate endotracheal intubation
- Pregnant patients
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
Minya university hospitals
Minya, Minya Governorate
Ahmad E Mahran, Professor, +201060027399, ahmed_ezz@mu.edu.eg
About this study
Official title: Different Modalities of Combined Noninvasive Ventilation With High Flow Nasal Oxygen Versus Noninvasive Ventilation Alone in Acute Respiratory Failure
After obtaining Institutional Ethical Committee approval of Faculty of Medicine, Minia University and written informed consent from patients or first- degree relatives, this prospective randomized non-blind comparative study will be conducted in adult intensive care unit (ICU) of Anesthesia, Intensive Care and Pain management department Minia university hospital over a period from September 2025 to April 2026. This study is designed to compare the effectiveness of two protocols of sequential use of High Flow Nasal Cannula (HFNC) and noninvasive ventilation (NIV) versus NIV alone in patients with Acute Respiratory failure (ARF) admitted to the intensive care unit (ICU). The study will include 75 patients of both sexes, classified as ASA class Ⅰ-ⅠⅠⅠ, divided into three groups with 25 patients in each group.
Read the detailed description
After failure of a trial of treatment with conventional oxygen therapy delivered through a face mask, with a FiO2 at least of 50% for 15 minutes, patients will be assigned into one of three groups:
- Group A: will receive first HFNC for 2 hours alternating with NIV for 1 hour. This alternating cycle of HFNC and NIV will be repeated for a total of 16 hours of HFNC and 8 hours of NIV for the first 24 hours.
- Group B: will receive first HFNC for 3 hours alternating with NIV for 3 hours. This alternating cycle of HFNC and NIV will be repeated for a total of 12 hours of HFNC and 12 hours of NIV for the first 24 hours.
- Group C (The control group): will receive conventional oxygen therapy and NIV as required for acute respiratory failure. Randomization will be performed using a computer-generated randomization sequence. HFNC therapy will be administered using the Vapotherm system (Vapotherm, INC. 100 Domain Drive. Exeter, NH 03833. Made In U.S.A.). This system allows for precise control of the fraction of inspired oxygen (FiO₂) and the delivery of heated, humidified gas via large-bore bi-nasal prongs. The initial flow rate will be set to 50 L/min with an FiO₂ of 0.5, and adjustments will be made to maintain SpO₂ ≥ 92%. If the initial settings are poorly tolerated by the patient, the flow rate and FiO₂ will be titrated to the maximum tolerated level, with a minimum flow rate of 30 L/min. Blood gas analysis will be performed within one hour of initiating HFNC to assess oxygenation, PaCO₂ and acid-base status. Continuous monitoring will be conducted throughout the session to ensure patient comfort and optimize therapeutic efficacy. NIV will be administered via a full-face mask connected to an ICU ventilator (TECME Corporation. Made In U.S.A. or Airliquide Medical Extend XT. Made In France.) equipped with a dedicated NIV mode and a heated humidifier (MR850, Fisher \& Paykel Healthcare), while patient positioned in a semi-recumbent position. The ventilator will be set to a pressure support level to achieve an expired tidal volume of 6-8 mL/kg of ideal body weight, with a target respiratory rate of < 30 breaths per minute. FiO₂ will be adjusted to maintain SpO₂ at 92%, and PEEP will be set at least 4 cm H₂O. All patients will be continuously monitored for respiratory rate, heart rate, blood pressure, and SpO₂ throughout the study. Blood gas analysis will be conducted within one hour after the initiation of HFNC and NIV to assess oxygenation, ventilation, and acid-base status. If improvement in respiratory distress occurs, the noninvasive strategy will be stopped. Also, The study will be discontinued and invasive mechanical ventilation will be initiated if any of the following criteria are recorded: evident worsening of respiratory distress, breathing frequency of ≥ 40 breaths/min, abundant secretions, SpO₂ remaining below 92% despite an FIO₂ of 1.0, or pH ≤ 7.35, Glasgow Coma Scale score < 8/15 or psychomotor agitation hindering nursing care, bradycardia (heart rate < 50 bpm), tachyarrhythmia (heart rate > 150 bpm), persistent hypotension (defined by systolic blood pressure < 90 mmHg or mean arterial blood pressure < 65 mm Hg, despite fluid resuscitation or need for vasopressors), respiratory or cardiopulmonary arrest
- Conditions
- Respiratory Failure
- Being tested
- HFNC, NIV
- Keywords
- Noninvasive technique in treatment of respiratory failure, Noninvasive ventilation, Respiratory failure, High flow nasal oxygen
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFNCDevice
High-flow nasal cannula (HFNC) is a valuable alternative for delivering oxygen therapy in patients with acute respiratory failure. It delivers heated and humidified oxygen at high flow rates-up to 60 L/min-through nasal prongs, allowing for better matching of inspiratory flow, a degree of positive airway pressure, and washout of nasopharyngeal dead space. These features contribute to improved oxygenation and reduced respiratory rate. Additionally, HFNC offers superior comfort and ease of communication compared to traditional masks, which may enhance patient compliance. Importantly, recent evidence suggests that HFNC can also assist in mild hypercapnic conditions by reducing the work of breathing and improving CO₂ clearance in selected patients
NIVDevice
Noninvasive ventilation (NIV) delivers positive airway pressure either continuously or in a bilevel mode to support ventilation and oxygenation. It has been widely used in managing conditions such as COPD exacerbations, cardiogenic pulmonary edema, and moderate forms of ARDS. NIV enhances alveolar ventilation, unloads respiratory muscles, and improves gas exchange while reducing the need for intubation in many cases. However, its effectiveness depends on proper patient selection and interface tolerance, and it may be less beneficial in patients with excessive secretions, altered mental status, or hemodynamic instability
| Study group | Role | What they receive |
|---|---|---|
| HFNC and NIV 2:1 | Experimental | This group will receive first HFNC for 2 hours alternating with NIV for
1 hour. This alternating cycle of HFNC and NIV will be repeated for a total of 16 hours of HFNC and 8 hours of NIV for the first 24 hours Receives: Device: HFNC; Device: NIV |
| HFNC and NIV 3:3 | Experimental | This group will receive first HFNC for 3 hours alternating with NIV for 3 hours. This alternating cycle of HFNC and NIV will be repeated for a total of 12 hours of HFNC and 12 hours of NIV for the first 24 hours Receives: Device: HFNC; Device: NIV |
| NIV only | Experimental | This group will receive conventional oxygen therapy and NIV as required for acute respiratory failure Receives: Device: NIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in PaO₂/FiO₂ ratio (the ratio of arterial oxygen partial pressure expressed in mmHg and the fraction of inspired oxygen expressed as a decimal)
The primary endpoint is the changes in PaO₂/FiO₂ ratio (the ratio of arterial oxygen partial pressure expressed in mmHg and the fraction of inspired oxygen expressed as a decimal) from baseline to 24 hours.
Measured: From baseline and thoughout the first 24 hours of the start of the technique
Secondary outcomes (7)
Changes in the arterial blood gases values: PH level, PaCO₂
Changes in the arterial blood gases values: PH level, PaCO₂ from baseline to 6, 12, 18 and 24h.
Measured: From baseline to 6th hour, 12th hour, 18th hour and 24th hour of the first day of the start of the technique.
Respiratory rate
Respiratory rate
Measured: At the baseline then at 6th hour, 12th hour, 18th hour and 24th hour of the first day of the start of the technique.
Changes in the dyspnea score
Borg dyspnea score
Measured: From baseline to 6th hour, 12th hour, 18th hour and 24th hour of the first day of the start of the technique.
Patient-reported comfort scores
VAS (Visual Analogue Score)
Measured: From baseline to 6th hour, 12th hour, 18th hour and 24th hour of the first day of the start of the technique.
Rate of endotracheal intubation within first 24 hours or continuation on respiratory support after 24 hours.
Rate of endotracheal intubation within first 24 hours or continuation on respiratory support after 24 hours.
Measured: During the first 24 hours of the start of the technique
Length of stay in ICU and hospital
Length of stay in ICU and hospital
Measured: Total days of hospital stay starting from the day of starting the intervention protocol until patient discharge from ICU or death (up to 100 days)
Time to death in ICU/hospital
Time to death in ICU/hospital
Measured: Total days starting from the start of intervention protocol until patient death (if occurred) (Up to 100 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Jun 2025
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Collaborators
- Minia University Hospital
- Responsible party
- Principal investigator, Esraa Yasser Ibrahim, Minia University
- Investigators
- Omyma S Mohamed, Prof., Principal investigator, ahmed_ezz@mu.edu.eg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521254
- Sponsor's protocol ID
- HFNC and NIV in ARF
- Status last verified
- Apr 2026
- First submitted
- 26 Nov 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Modalities of Combined Noninvasive Ventilation With High Flow Nasal Oxygen Versus Noninvasive Ventilation Alone in Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT07521254
- Acronym / sponsor ID
- HFNC and NIV in ARF
- Conditions
- Respiratory Failure
- Keywords
- Noninvasive technique in treatment of respiratory failure, Noninvasive ventilation, Respiratory failure, High flow nasal oxygen
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Collaborators
- Minia University Hospital
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 9 Apr 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.
After obtaining Institutional Ethical Committee approval of Faculty of Medicine, Minia University and written informed consent from patients or first- degree relatives, this prospective randomized non-blind comparative study will be conducted in adult intensive care unit (ICU) of Anesthesia, Intensive Care and Pain management department Minia university hospital over a period from September 2025 to April 2026. This study is designed to compare the effectiveness of two protocols of sequential use of High Flow Nasal Cannula (HFNC) and noninvasive ventilation (NIV) versus NIV alone in patients with Acute Respiratory failure (ARF) admitted to the intensive care unit (ICU). The study will include 75 patients of both sexes, classified as ASA class Ⅰ-ⅠⅠⅠ, divided into three groups with 25 patients in each group.
Detailed description
After failure of a trial of treatment with conventional oxygen therapy delivered through a face mask, with a FiO2 at least of 50% for 15 minutes, patients will be assigned into one of three groups:
- Group A: will receive first HFNC for 2 hours alternating with NIV for 1 hour. This alternating cycle of HFNC and NIV will be repeated for a total of 16 hours of HFNC and 8 hours of NIV for the first 24 hours.
- Group B: will receive first HFNC for 3 hours alternating with NIV for 3 hours. This alternating cycle of HFNC and NIV will be repeated for a total of 12 hours of HFNC and 12 hours of NIV for the first 24 hours.
- Group C (The control group): will receive conventional oxygen therapy and NIV as required for acute respiratory failure. Randomization will be performed using a computer-generated randomization sequence. HFNC therapy will be administered using the Vapotherm system (Vapotherm, INC. 100 Domain Drive. Exeter, NH 03833. Made In U.S.A.). This system allows for precise control of the fraction of inspired oxygen (FiO₂) and the delivery of heated, humidified gas via large-bore bi-nasal prongs. The initial flow rate will be set to 50 L/min with an FiO₂ of 0.5, and adjustments will be made to maintain SpO₂ ≥ 92%. If the initial settings are poorly tolerated by the patient, the flow rate and FiO₂ will be titrated to the maximum tolerated level, with a minimum flow rate of 30 L/min. Blood gas analysis will be performed within one hour of initiating HFNC to assess oxygenation, PaCO₂ and acid-base status. Continuous monitoring will be conducted throughout the session to ensure patient comfort and optimize therapeutic efficacy. NIV will be administered via a full-face mask connected to an ICU ventilator (TECME Corporation. Made In U.S.A. or Airliquide Medical Extend XT. Made In France.) equipped with a dedicated NIV mode and a heated humidifier (MR850, Fisher \& Paykel Healthcare), while patient positioned in a semi-recumbent position. The ventilator will be set to a pressure support level to achieve an expired tidal volume of 6-8 mL/kg of ideal body weight, with a target respiratory rate of < 30 breaths per minute. FiO₂ will be adjusted to maintain SpO₂ at 92%, and PEEP will be set at least 4 cm H₂O. All patients will be continuously monitored for respiratory rate, heart rate, blood pressure, and SpO₂ throughout the study. Blood gas analysis will be conducted within one hour after the initiation of HFNC and NIV to assess oxygenation, ventilation, and acid-base status. If improvement in respiratory distress occurs, the noninvasive strategy will be stopped. Also, The study will be discontinued and invasive mechanical ventilation will be initiated if any of the following criteria are recorded: evident worsening of respiratory distress, breathing frequency of ≥ 40 breaths/min, abundant secretions, SpO₂ remaining below 92% despite an FIO₂ of 1.0, or pH ≤ 7.35, Glasgow Coma Scale score < 8/15 or psychomotor agitation hindering nursing care, bradycardia (heart rate < 50 bpm), tachyarrhythmia (heart rate > 150 bpm), persistent hypotension (defined by systolic blood pressure < 90 mmHg or mean arterial blood pressure < 65 mm Hg, despite fluid resuscitation or need for vasopressors), respiratory or cardiopulmonary arrest
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HFNC and NIV 2:1 | Experimental | Device: HFNC, Device: NIVThis group will receive first HFNC for 2 hours alternating with NIV for 1 hour. This alternating cycle of HFNC and NIV will be repeated for a total of 16 hours of HFNC and 8 hours of NIV for the first 24 hours |
| HFNC and NIV 3:3 | Experimental | Device: HFNC, Device: NIVThis group will receive first HFNC for 3 hours alternating with NIV for 3 hours. This alternating cycle of HFNC and NIV will be repeated for a total of 12 hours of HFNC and 12 hours of NIV for the first 24 hours |
| NIV only | Experimental | Device: NIVThis group will receive conventional oxygen therapy and NIV as required for acute respiratory failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥18 year of both sexes. • Diagnosed with Acute Respiratory Failure (ARF) defined as the combination of a PaO2/FiO2 ratio < 300 after 15 minutes of conventional oxygen delivered through a face mask, with a FiO2 at least of 50% and respiratory rate > 30 breaths/min.
Key exclusion criteria (9 listed)
- Chronic respiratory disease
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 |
|---|---|---|
| HFNCHigh-flow nasal cannula (HFNC) is a valuable alternative for delivering oxygen therapy in patients with acute respiratory failure. It delivers heated and humidified oxygen at high flow rates-up to 60 L/min-through nasal prongs, allowing for better matching of inspiratory flow, a degree of positive airway pressure, and washout of nasopharyngeal dead space. These features contribute to improved oxygenation and reduced respiratory rate. Additionally, HFNC offers superior comfort and ease of communication compared to traditional masks, which may enhance patient compliance. Importantly, recent evidence suggests that HFNC can also assist in mild hypercapnic conditions by reducing the work of breathing and improving CO₂ clearance in selected patients | Device | HFNC and NIV 2:1, HFNC and NIV 3:3 |
| NIVNoninvasive ventilation (NIV) delivers positive airway pressure either continuously or in a bilevel mode to support ventilation and oxygenation. It has been widely used in managing conditions such as COPD exacerbations, cardiogenic pulmonary edema, and moderate forms of ARDS. NIV enhances alveolar ventilation, unloads respiratory muscles, and improves gas exchange while reducing the need for intubation in many cases. However, its effectiveness depends on proper patient selection and interface tolerance, and it may be less beneficial in patients with excessive secretions, altered mental status, or hemodynamic instability | Device | HFNC and NIV 2:1, HFNC and NIV 3:3, NIV only |
Primary outcome
The changes in PaO₂/FiO₂ ratio (the ratio of arterial oxygen partial pressure expressed in mmHg and the fraction of inspired oxygen expressed as a decimal)
Time frame: From baseline and thoughout the first 24 hours of the start of the technique
The primary endpoint is the changes in PaO₂/FiO₂ ratio (the ratio of arterial oxygen partial pressure expressed in mmHg and the fraction of inspired oxygen expressed as a decimal) from baseline to 24 hours.
7 secondary outcomes
Changes in the arterial blood gases values: PH level, PaCO₂
Time frame: From baseline to 6th hour, 12th hour, 18th hour and 24th hour of the first day of the start of the technique.
Respiratory rate
Time frame: At the baseline then at 6th hour, 12th hour, 18th hour and 24th hour of the first day of the start of the technique.
Changes in the dyspnea score
Time frame: From baseline to 6th hour, 12th hour, 18th hour and 24th hour of the first day of the start of the technique.
Patient-reported comfort scores
Time frame: From baseline to 6th hour, 12th hour, 18th hour and 24th hour of the first day of the start of the technique.
Rate of endotracheal intubation within first 24 hours or continuation on respiratory support after 24 hours.
Time frame: During the first 24 hours of the start of the technique
Length of stay in ICU and hospital
Time frame: Total days of hospital stay starting from the day of starting the intervention protocol until patient discharge from ICU or death (up to 100 days)
Time to death in ICU/hospital
Time frame: Total days starting from the start of intervention protocol until patient death (if occurred) (Up to 100 days)
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 9 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Omyma S Mohamed, Prof. principal investigator
ahmed_ezz@mu.edu.eg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFNC and NIV in people with Respiratory Failure, run by Minia University 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 9 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 9 Apr 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 Omyma S Mohamed, Prof. (0106 1762894, Omaima.Shehata@mu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in PaO₂/FiO₂ ratio (the ratio of arterial oxygen partial pressure expressed in mmHg and the fraction of inspired oxygen expressed as a decimal) (time frame: From baseline and thoughout the first 24 hours of the start of the technique). 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 9 Apr 2026.