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Completed

NCT Number: NCT07084870

HFNO VERSUS BIPAP 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

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Key information

Conditions

HFNO vs BIPAP Preeclamptic Acute Hypoxaemic Respiratory Failure

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Alexandria University

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

High Flow Nasal Oxygen

Other

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 BIPAP

Other

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.

Primary outcomes

  1. treatment success

    Time frame: 48 hours

    measure the success of treatment technique by the improvement of PaO2/ FiO2 ratio, peripheral oxygen saturation

  2. 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

Secondary outcomes

  1. 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

    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

  2. Assess the patient's comfort and tolerance to the technique used.

    Time frame: 48 hours

    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.

  3. Record any possible complications related to treatment. Record any possible complications related to treatment. Record any possible complications

    Time frame: 48 hours

    Record any possible complications related to treatment.

    Facial skin erythema, nasal skin lesions, eye irritation, vomiting related to treatment

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Acronym: HFNO BIPAP

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2025
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.