HFNO vs BIPAPHFNO BIPAPNCT07084870
HFNO VERSUS BIPAP IN PREECLAMPTIC PATIENTS WITH ACUTE HYPOXAEMIC RESPIRATORY FAILURE
A study testing High flow nasal oxygen and non invasive BIPAP in people with HFNO vs BIPAP and Preeclamptic Acute Hypoxaemic Respiratory Failure, run by Alexandria University at 1 site in Egypt.
Trial summary
The aim of this study was to evaluate the use of HFNO to support oxygenation in acute hypoxemic respiratory failure in postpartum pre-eclamptic patients, compared with non-invasive intermittent bilevel positive airway pressure ventilation Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- HFNO vs BIPAP, Preeclamptic Acute Hypoxaemic Respiratory Failure
- What is being tested?
- High flow nasal oxygen and non invasive BIPAP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 20 Mar 2025
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- preeclamptic postpartum patients, admitted to obstetric intensive care unit (ICU) due to acute hypoxaemic respiratory failure, fully conscious with The American Society of Anesthesiologists (ASA) class II or III.
Who cannot join
- Patients with PaCO2 more than 45 mmHg.
- Unconscious patients.
- PaO2/ FiO2 ratio less than 150.
- Known cardiac disease.
- Hemodynamic instability.
- Facial deformity.
- Morbid obese patients with BMI >40
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HIGH FLOW NASAL OXYGEN VERSUS BILEVEL POSITIVE AIRWAY PRESSURE VENTILATION IN PREECLAMPTIC PATIENTS WITH ACUTE HYPOXAEMIC RESPIRATORY FAILURE
The aim of this study was to evaluate the use of HFNO to support oxygenation in acute hypoxemic respiratory failure in postpartum pre-eclamptic patients, compared with non-invasive intermittent bilevel positive airway pressure ventilation
Read the detailed description
Patients in group I will receive HFNO by AIRVO™ (Fisher \& Paykel Healthcare Ltd., Auckland, New Zealand). The initial flow rate will be 50L/min and will eventually be diminished in case of intolerance. Humidification chamber temperature will be set at 37 °C and will eventually be diminished in case of intolerance. FiO2 will be 100% and then gradually reduced to 50% when pulse oximetry values are acceptable. Patients in the group II will receive oxygen therapy via intermittent non- invasive positive pressure ventilation, BiPAP mode Dräger Savina ventilator, and a face mask will be used. P (low) of 5 cm H2O to 10 cm H2O and an inspiratory pressure P (high) of 10-20 cm H2O above PEEP. FiO2 will be 100% and then gradually reduced to 50 % when pulse oximetry values are acceptable. Respiratory rate will be from 10-12. It will be applied for 30 minutes every hour with 30 minutes rest, and will be applied continuously for 6-8 hours at night. The size of the face mask will be chosen to optimize subject comfort while minimizing air leaks. If the patient cannot tolerate the treatment, she will be excluded from the study. Patients will be assessed for treatment weaning then interruption when they meet the following criteria:
- Respiratory rate ≤24 breaths/min
- No recruitment of accessory muscles of respiration during calm breathing.
- Haemodynamic stability (heart rate <110/min; mean blood pressure between 60 and 90 mmHg and no Haemodynamically significant arrhythmias.
- SpO2 > 95 % on FIO2 ≤30.
- Improvement of blood gases.
Criteria for treatment failure and the need for intubation:
- Respiratory rate > 25 breaths/min
- The use of accessory muscles of respiration.
- Haemodynamic instability (heart rate >110/min; mean blood pressure below 90 or significant arrhythmias.
- Failure to achieve SpO2 above 91.
- PaO2/ FiO2 ratio <150, PaCO2 >45 or PH <7.30.
- Being tested
- High flow nasal oxygen, non invasive BIPAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal oxygenOther
Patients in group I then received HFNO. The initial flow rate was adjusted to 50L/min and gradually reduced as tolerated by the patient. The humidification chamber temperature was set at 37°C and gradually reduced to the patient comfort. FiO2 was 100% and then gradually reduced over time according to improvement in oxygenation.
non invasive BIPAPOther
Patients in group II received oxygen therapy via intermittent non- invasive positive pressure ventilation, BiPAP mode ventilator using a face mask. BiPAP settings were adjusted as follows: P (low) of 5cm H2O to 10cm H2O and an inspiratory pressure P (high) of 10-20cm H2O . FiO2 was adjusted to 100% and then gradually reduced over time according to improvement in oxygen saturation and PaO2/Fio2 ratio. Respiratory rate was adjusted from 10-12 at then changed according to patient´s respiratory effort and according to ABG.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 30 preeclamptic patients with acute hypoxaemic respiratory failure who received O2 therapy via HFNC Receives: Other: High flow nasal oxygen |
| Group 2 | Experimental | 30 preeclamptic patients with acute hypoxaemic respiratory failure who received non-invasive BiPAP ventilation. Receives: Other: non invasive BIPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment success
measure the success of treatment technique by the improvement of PaO2/ FiO2 ratio, peripheral oxygen saturation
Measured: 48 hours
Treatment failure
reatment failure by recording the number of tracheal intubations in the first 48 hours after the start of the treatment
Measured: 48 hours
Secondary outcomes (3)
Assess the level of oxidative stress by measuring serum level of soluble Nox2 derived peptide (sNOX2-dp), a marker of NADPH-oxidase activation
Extracellular levels of soluble NOX2 derived peptide (sNOX2-dp), a marker of NADPH oxidase activation, will be detected by ELISA. It will be measured on admission and 6 hours after initiation of oxygen therapy
Measured: 6 hours
Assess the patient's comfort and tolerance to the technique used.
assessed by Visual numeric scale (VNS): A range from 1 to 5 will be used. With 1 very comfortable,2 comfortable, 3 uncomfortable, 4 very uncomfortable, 5 the worst discomfort.
Measured: 48 hours
Record any possible complications related to treatment. Record any possible complications related to treatment. Record any possible complications
Record any possible complications related to treatment.
Facial skin erythema, nasal skin lesions, eye irritation, vomiting related to treatment
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Apr 2022
- Primary completion20 Mar 2025
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HFNO vs BIPAPStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shahira Ahmed Yousef Elmetiny, MD, Study director, Alexandria UniversityTarek Atef Tawfik, MD, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084870
- Sponsor's protocol ID
- 0201403
- Acronym
- HFNO BIPAP
- Status last verified
- Jul 2025
- First submitted
- 23 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: through clinical trials
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIGH FLOW NASAL OXYGEN VERSUS BILEVEL POSITIVE AIRWAY PRESSURE VENTILATION IN PREECLAMPTIC PATIENTS WITH ACUTE HYPOXAEMIC RESPIRATORY FAILURE
- ClinicalTrials.gov ID
- NCT07084870
- Acronym / sponsor ID
- HFNO BIPAP / 0201403
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 25 Jul 2025 (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.
The aim of this study was to evaluate the use of HFNO to support oxygenation in acute hypoxemic respiratory failure in postpartum pre-eclamptic patients, compared with non-invasive intermittent bilevel positive airway pressure ventilation
Detailed description
Patients in group I will receive HFNO by AIRVO™ (Fisher \& Paykel Healthcare Ltd., Auckland, New Zealand). The initial flow rate will be 50L/min and will eventually be diminished in case of intolerance. Humidification chamber temperature will be set at 37 °C and will eventually be diminished in case of intolerance. FiO2 will be 100% and then gradually reduced to 50% when pulse oximetry values are acceptable. Patients in the group II will receive oxygen therapy via intermittent non- invasive positive pressure ventilation, BiPAP mode Dräger Savina ventilator, and a face mask will be used. P (low) of 5 cm H2O to 10 cm H2O and an inspiratory pressure P (high) of 10-20 cm H2O above PEEP. FiO2 will be 100% and then gradually reduced to 50 % when pulse oximetry values are acceptable. Respiratory rate will be from 10-12. It will be applied for 30 minutes every hour with 30 minutes rest, and will be applied continuously for 6-8 hours at night. The size of the face mask will be chosen to optimize subject comfort while minimizing air leaks. If the patient cannot tolerate the treatment, she will be excluded from the study. Patients will be assessed for treatment weaning then interruption when they meet the following criteria:
- Respiratory rate ≤24 breaths/min
- No recruitment of accessory muscles of respiration during calm breathing.
- Haemodynamic stability (heart rate <110/min; mean blood pressure between 60 and 90 mmHg and no Haemodynamically significant arrhythmias.
- SpO2 > 95 % on FIO2 ≤30.
- Improvement of blood gases.
Criteria for treatment failure and the need for intubation:
- Respiratory rate > 25 breaths/min
- The use of accessory muscles of respiration.
- Haemodynamic instability (heart rate >110/min; mean blood pressure below 90 or significant arrhythmias.
- Failure to achieve SpO2 above 91.
- PaO2/ FiO2 ratio <150, PaCO2 >45 or PH <7.30.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: High flow nasal oxygen30 preeclamptic patients with acute hypoxaemic respiratory failure who received O2 therapy via HFNC |
| Group 2 | Experimental | Other: non invasive BIPAP30 preeclamptic patients with acute hypoxaemic respiratory failure who received non-invasive BiPAP ventilation. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- preeclamptic postpartum patients, admitted to obstetric intensive care unit (ICU) due to acute hypoxaemic respiratory failure, fully conscious with The American Society of Anesthesiologists (ASA) class II or III.
Key exclusion criteria (7 listed)
- Patients with PaCO2 more than 45 mmHg.
- Unconscious patients.
- PaO2/ FiO2 ratio less than 150.
- Known cardiac disease.
- Hemodynamic instability.
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 oxygenPatients in group I then received HFNO. The initial flow rate was adjusted to 50L/min and gradually reduced as tolerated by the patient. The humidification chamber temperature was set at 37°C and gradually reduced to the patient comfort. FiO2 was 100% and then gradually reduced over time according to improvement in oxygenation. | Other | Group 1 |
| non invasive BIPAPPatients in group II received oxygen therapy via intermittent non- invasive positive pressure ventilation, BiPAP mode ventilator using a face mask. BiPAP settings were adjusted as follows: P (low) of 5cm H2O to 10cm H2O and an inspiratory pressure P (high) of 10-20cm H2O . FiO2 was adjusted to 100% and then gradually reduced over time according to improvement in oxygen saturation and PaO2/Fio2 ratio. Respiratory rate was adjusted from 10-12 at then changed according to patient´s respiratory effort and according to ABG. | Other | Group 2 |
Primary outcome
treatment success
Time frame: 48 hours
measure the success of treatment technique by the improvement of PaO2/ FiO2 ratio, peripheral oxygen saturation
Treatment failure
Time frame: 48 hours
reatment failure by recording the number of tracheal intubations in the first 48 hours after the start of the treatment
3 secondary outcomes
Assess the level of oxidative stress by measuring serum level of soluble Nox2 derived peptide (sNOX2-dp), a marker of NADPH-oxidase activation
Time frame: 6 hours
Assess the patient's comfort and tolerance to the technique used.
Time frame: 48 hours
Record any possible complications related to treatment. Record any possible complications related to treatment. Record any possible complications
Time frame: 48 hours
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 29 Jul 2025.
- Individual participant dataSharing planned: Yes. through clinical trials
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.
Shahira Ahmed Yousef Elmetiny, MD study director
Alexandria University
Tarek Atef Tawfik, MD study director
Alexandria 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 oxygen and non invasive BIPAP in people with HFNO vs BIPAP and Preeclamptic Acute Hypoxaemic Respiratory Failure, run by Alexandria 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 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 29 Jul 2025. 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?
treatment success (time frame: 48 hours). The study lists 2 primary outcomes in all. 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 29 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.