NCT07084870

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2025

Completed
Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

3 years

First QC Date

July 23, 2025

Last Update Submit

July 24, 2025

Conditions

HFNO vs BIPAPPreeclamptic Acute Hypoxaemic Respiratory Failure

Outcome Measures

Primary Outcomes (2)

  • treatment success

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

    48 hours

  • Treatment failure

    reatment failure by recording the number of tracheal intubations in the first 48 hours after the start of the treatment

    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

    6 hours

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

    48 hours

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

    48 hours

Study Arms (2)

Group 1

EXPERIMENTAL

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

Other: High flow nasal oxygen

Group 2

EXPERIMENTAL

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

Other: non invasive BIPAP

Interventions

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.

Group 1
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.

Group 2

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspostpartum preeclamptic patients
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Alexandria University

Alexandria, Egypt, Egypt

Location

Study Officials

  • Shahira Ahmed Yousef Elmetiny, MD

    Alexandria University

    STUDY DIRECTOR

  • Tarek Atef Tawfik, MD

    Alexandria University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single (Outcomes Assessor) single
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2025

First Posted

July 25, 2025

Study Start

April 1, 2022

Primary Completion

March 20, 2025

Study Completion

March 20, 2025

Last Updated

July 29, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

through clinical trials

Shared Documents
STUDY PROTOCOL, SAP, ICF
Access Criteria
HFNO, BIPAP, acute hypoxaemic respiratory failure, preeclampsia

Locations

EG(1)