PneumoniaNCT05809089
HFNO in Pneumonia Patients Presenting With Acute Hypoxemic Respiratory Failure
A study testing High flow nasal cannula (HFNC) and Noninvasive ventilation (NIV) in people with Pneumonia, run by Assiut University at 1 site in Egypt.
Trial summary
High-flow nasal oxygen (HFNO) therapy is an upcoming and beneficial modality for patients with acute hypoxemic respiratory failure (AHRF). To evaluate whether early use of HFNO in pneumonia patients with (AHRF) can reduce the need for invasive ventilation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- High flow nasal cannula (HFNC) and Noninvasive ventilation (NIV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2020to 20 Feb 2023
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pneumonia adults patients (age>18 years) with AHRF were eligible for this study after conventional oxygen therapy failure.
- The criteria for diagnosing AHRF were defined as the presence of a respiratory rate (RR) more than 25 breaths/min with SpO2 less than 92%, and/or the arterial oxygen partial pressure (PaO2) to FiO2 ratio less than 300 mmHg while breathing oxygen delivered by a conventional venturi device at a fraction of inspiration oxygen of 0.5 (as per maximum for Venturi mask) administered for at least 60 minutes.
Who cannot join
- Patients requiring emergency intubation,
- Recent esophageal, facial, or cranial trauma or surgery,
- Severely decreased consciousness (Glasgow coma scale [GCS] of 11 or less),
- Severe hemodynamic instability (patient on inotropic or vasopressor support), ° Severe ventricular arrhythmia or myocardial ischemia,
- Tracheotomy or other upper airway disorders,
- Active upper gastrointestinal bleeding, and
- Inability to clear respiratory secretions .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early-initiated High Flow Nasal Oxygen Therapy in Pneumonia Patients Presenting With Acute Hypoxemic Respiratory Failure
High-flow nasal oxygen (HFNO) therapy is an upcoming and beneficial modality for patients with acute hypoxemic respiratory failure (AHRF).
To evaluate whether early use of HFNO in pneumonia patients with (AHRF) can reduce the need for invasive ventilation.
Read the detailed description
- Pneumonia adults patients (age>18 years) with AHRF were eligible for this study after conventional oxygen therapy failure.
- The criteria for diagnosing AHRF were defined as the presence of a respiratory rate (RR) more than 25 breaths/min with SpO2 less than 92%, and/or the arterial oxygen partial pressure (PaO2) to FiO2 ratio less than 300 mmHg while breathing oxygen delivered by a conventional venturi device at a fraction of inspiration oxygen of 0.5 (as per maximum for Venturi mask) administered for at least 60 minutes.
Eligible patients were randomized to receive either HFNO or NIV respiratory support throughout the hospitalization period. Randomization was stratified by a laboratory scientist not involved in the study using the technique of shuffled sealed envelopes.
- Conditions
- Pneumonia
- Being tested
- High flow nasal cannula (HFNC), Noninvasive ventilation (NIV)
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal cannula (HFNC)Device
High-flow nasal cannula device was utilized. Humidifier temperature was set at 37°C via large-bore bi-nasal prongs, and inspired oxygen (FiO2) was adjusted to maintain oxygen saturation by pulse oximetry (SpO2) ≥ 90%.The flow was initially set at 10 L/min and titrated upward in 5 L/min steps until patients experienced discomfort.
Patient will be evaluated every 8 hours and discontinued the device for eating, drinking and coughing up secretion and returned back to the device for 72 hours.
Noninvasive ventilation (NIV)Device
Patients initiated NIV; Inspiratory positive airway pressure (IPAP) was initiated at 10-12 cmH2O, and expiratory positive airway pressure (EPAP) started at 4-5 cmH2O. FIO2 was adjusted to maintain SpO2 ≥ 90%. The same protocol as done in HFNC, patient will be evaluated every 8 hours and discontinued the device and returned back to the device for re- evaluation within 72 hours
| Study group | Role | What they receive |
|---|---|---|
| (High flow nasal cannula (HFNC) | Active comparator | This arm should have the intervention"High flow nasal cannula (HFNC)" assigned to it. Receives: Device: High flow nasal cannula (HFNC) |
| Noninvasive ventilation (NIV) | Active comparator | This arm should have the intervention "Noninvasive ventilation (NIV)" assigned to it. Receives: Device: Noninvasive ventilation (NIV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of intubation among participant
The criteria for immediate intubation were: cardiac arrest or obvious hemodynamic instability, refractory hypoxemia (PaO2 < 50mmHg with sufficient oxygen therapy), significant hypercapnia with pH ≤ 7.20, loss of consciousness or gasping for air, psychomotor agitation, or severe dyspnea (respiratory frequency > 40/min)
Measured: within 72 hours after admission
Secondary outcomes (3)
Improvement of respiratory exchanges compared to baseline
Evaluation of oxygenation (paO2 in mmHg )and hypercapnea (Pa Co2 in mmHg )using arterial blood gas )
Measured: hospital admission until the achievement of clinical stability (72 hours)
Dyspnea
Borg dyspnea scale
Measured: hospital admission until the achievement of clinical stability (72 hours)
Mortality rate
Patient died after reintubation
Measured: at 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start20 Nov 2020
- Primary completion20 Jan 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Magdy Eid, Assiut University
- Investigators
- ahmed metwaly, dectorate, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809089
- Sponsor's protocol ID
- 04355751
- Status last verified
- Aug 2023
- First submitted
- 6 Mar 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Magdy DM. Outcome of Early Initiation of High-flow Nasal Oxygen Therapy among Pneumonia Patients Presenting with Acute Hypoxemic Respiratory Failure. Indian J Crit Care Med. 2024 Aug;28(8):753-759. doi: 10.5005/jp-journals-10071-24769. Epub 2024 Jul 31.
PubMed 39239186
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early-initiated High Flow Nasal Oxygen Therapy in Pneumonia Patients Presenting With Acute Hypoxemic Respiratory Failure
- ClinicalTrials.gov ID
- NCT05809089
- Acronym / sponsor ID
- 04355751
- Conditions
- Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 12 Apr 2023 (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.
High-flow nasal oxygen (HFNO) therapy is an upcoming and beneficial modality for patients with acute hypoxemic respiratory failure (AHRF).
To evaluate whether early use of HFNO in pneumonia patients with (AHRF) can reduce the need for invasive ventilation.
Detailed description
- Pneumonia adults patients (age>18 years) with AHRF were eligible for this study after conventional oxygen therapy failure.
- The criteria for diagnosing AHRF were defined as the presence of a respiratory rate (RR) more than 25 breaths/min with SpO2 less than 92%, and/or the arterial oxygen partial pressure (PaO2) to FiO2 ratio less than 300 mmHg while breathing oxygen delivered by a conventional venturi device at a fraction of inspiration oxygen of 0.5 (as per maximum for Venturi mask) administered for at least 60 minutes.
Eligible patients were randomized to receive either HFNO or NIV respiratory support throughout the hospitalization period. Randomization was stratified by a laboratory scientist not involved in the study using the technique of shuffled sealed envelopes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (High flow nasal cannula (HFNC) | Active comparator | Device: High flow nasal cannula (HFNC)This arm should have the intervention"High flow nasal cannula (HFNC)" assigned to it. |
| Noninvasive ventilation (NIV) | Active comparator | Device: Noninvasive ventilation (NIV)This arm should have the intervention "Noninvasive ventilation (NIV)" assigned to it. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pneumonia adults patients (age>18 years) with AHRF were eligible for this study after conventional oxygen therapy failure.
- The criteria for diagnosing AHRF were defined as the presence of a respiratory rate (RR) more than 25 breaths/min with SpO2 less than 92%, and/or the arterial oxygen partial pressure (PaO2) to FiO2 ratio less than 300 mmHg while breathing oxygen delivered by a conventional venturi device at a fraction of inspiration oxygen of 0.5 (as per maximum for Venturi mask) administered for at least 60 minutes.
Key exclusion criteria (7 listed)
- Patients requiring emergency intubation,
- Recent esophageal, facial, or cranial trauma or surgery,
- Severely decreased consciousness (Glasgow coma scale [GCS] of 11 or less),
- Severe hemodynamic instability (patient on inotropic or vasopressor support), ° Severe ventricular arrhythmia or myocardial ischemia,
- Tracheotomy or other upper airway disorders,
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 cannula (HFNC)High-flow nasal cannula device was utilized. Humidifier temperature was set at 37°C via large-bore bi-nasal prongs, and inspired oxygen (FiO2) was adjusted to maintain oxygen saturation by pulse oximetry (SpO2) ≥ 90%.The flow was initially set at 10 L/min and titrated upward in 5 L/min steps until patients experienced discomfort. Patient will be evaluated every 8 hours and discontinued the device for eating, drinking and coughing up secretion and returned back to the device for 72 hours. | Device | (High flow nasal cannula (HFNC) |
| Noninvasive ventilation (NIV)Patients initiated NIV; Inspiratory positive airway pressure (IPAP) was initiated at 10-12 cmH2O, and expiratory positive airway pressure (EPAP) started at 4-5 cmH2O. FIO2 was adjusted to maintain SpO2 ≥ 90%. The same protocol as done in HFNC, patient will be evaluated every 8 hours and discontinued the device and returned back to the device for re- evaluation within 72 hours | Device | Noninvasive ventilation (NIV) |
Primary outcome
The rate of intubation among participant
Time frame: within 72 hours after admission
The criteria for immediate intubation were: cardiac arrest or obvious hemodynamic instability, refractory hypoxemia (PaO2 < 50mmHg with sufficient oxygen therapy), significant hypercapnia with pH ≤ 7.20, loss of consciousness or gasping for air, psychomotor agitation, or severe dyspnea (respiratory frequency > 40/min)
3 secondary outcomes
Improvement of respiratory exchanges compared to baseline
Time frame: hospital admission until the achievement of clinical stability (72 hours)
Dyspnea
Time frame: hospital admission until the achievement of clinical stability (72 hours)
Mortality rate
Time frame: at 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Derived from this study: PubMed 39239186Magdy DM. Outcome of Early Initiation of High-flow Nasal Oxygen Therapy among Pneumonia Patients Presenting with Acute Hypoxemic Respiratory Failure. Indian J Crit Care Med. 2024 Aug;28(8):753-759. doi: 10.5005/jp-journals-10071-24769. Epub 2024 Jul 31.
- 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. This study is not recruiting at the moment.
ahmed metwaly, dectorate principal investigator
Assiut University
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 (HFNC) and Noninvasive ventilation (NIV) in people with Pneumonia, run by Assiut 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 25 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of intubation among participant (time frame: within 72 hours after admission). 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 NCT05809089, which also lists 1 linked publication.
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 25 Aug 2023.