NCT07084870

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• HFNO vs BIPAP
• Preeclamptic Acute Hypoxaemic Respiratory Failure

Interventions

Type	Name	Description
OTHER	High flow nasal oxygen	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.
OTHER	non 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.

Timeline

• Start date: 2022-04-01
• Primary completion: 2025-03-20
• Completion: 2025-03-20
• First posted: 2025-07-25
• Last updated: 2025-07-29

Locations

1 site across 1 country: Egypt