HFNO VERSUS BIPAP IN PREECLAMPTIC PATIENTS WITH ACUTE HYPOXAEMIC RESPIRATORY FAILURE

NCT ID: NCT07084870

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2025-03-20

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.

Conditions

HFNO vs BIPAP; Preeclamptic Acute Hypoxaemic Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1

30 preeclamptic patients with acute hypoxaemic respiratory failure who received O2 therapy via HFNC

Group Type: EXPERIMENTAL

High flow nasal oxygen

Intervention Type: 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.

Group 2

30 preeclamptic patients with acute hypoxaemic respiratory failure who received non-invasive BiPAP ventilation.

Group Type: EXPERIMENTAL

non invasive BIPAP

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shahira Ahmed Yousef Elmetiny, MD

Role: STUDY_DIRECTOR

Alexandria University

Tarek Atef Tawfik, MD

Role: STUDY_DIRECTOR

Alexandria University

Locations

Faculty of Medicine, Alexandria University

Alexandria, Egypt, Egypt

Countries

Egypt

Other Identifiers

0201403

Identifier Type: -

Identifier Source: org_study_id