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HFNO VERSUS BIPAP IN PREECLAMPTIC PATIENTS WITH ACUTE HYPOXAEMIC RESPIRATORY FAILURE

HIGH FLOW NASAL OXYGEN VERSUS BILEVEL POSITIVE AIRWAY PRESSURE VENTILATION IN PREECLAMPTIC PATIENTS WITH ACUTE HYPOXAEMIC RESPIRATORY FAILURE

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07084870
Acronym
HFNO BIPAP
Enrollment
60
Registered
2025-07-25
Start date
2022-04-01
Completion date
2025-03-20
Last updated
2025-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HFNO vs BIPAP, Preeclamptic Acute Hypoxaemic Respiratory Failure

Brief 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

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.

Interventions

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.

OTHERnon invasive BIPAP

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.

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Single (Outcomes Assessor) single

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

1. Patients with PaCO2 more than 45 mmHg. 2. Unconscious patients. 3. PaO2/ FiO2 ratio less than 150. 4. Known cardiac disease. 5. Hemodynamic instability. 6. Facial deformity. 7. Morbid obese patients with BMI \>40

Design outcomes

Primary

MeasureTime frameDescription
treatment success48 hoursmeasure the success of treatment technique by the improvement of PaO2/ FiO2 ratio, peripheral oxygen saturation
Treatment failure48 hoursreatment failure by recording the number of tracheal intubations in the first 48 hours after the start of the treatment

Secondary

MeasureTime frameDescription
Assess the level of oxidative stress by measuring serum level of soluble Nox2 derived peptide (sNOX2-dp), a marker of NADPH-oxidase activation6 hoursExtracellular 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
Assess the patient's comfort and tolerance to the technique used.48 hoursassessed 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.
Record any possible complications related to treatment. Record any possible complications related to treatment. Record any possible complications48 hoursRecord any possible complications related to treatment. Facial skin erythema, nasal skin lesions, eye irritation, vomiting related to treatment

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026