HIGH FLOW NASAL OXYGEN VERSUS BILEVEL POSITIVE AIRWAY PRESSURE VENTILATION IN PREECLAMPTIC PATIENTS WITH ACUTE HYPOXAEMIC RESPIRATORY FAILURE
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alexandria University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- treatment success
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Single (Outcomes Assessor) single
Eligibility Criteria
- Sex
- Female
- Accepts 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
- •Patients with PaCO2 more than 45 mmHg.
- •Unconscious patients.
- •PaO2/ FiO2 ratio less than
- •Known cardiac disease.
- •Hemodynamic instability.
- •Facial deformity.
- •Morbid obese patients with BMI \>40
Outcomes
Primary Outcomes
treatment success
Time Frame: 48 hours
measure the success of treatment technique by the improvement of PaO2/ FiO2 ratio, peripheral oxygen saturation
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
- Record any possible complications related to treatment. Record any possible complications related to treatment. Record any possible complications(48 hours)
- 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)