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临床试验/NCT07084870
NCT07084870已完成不适用

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

Alexandria University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
treatment success

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Single (Outcomes Assessor) single

入排标准

性别
Female
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

Group 1

Experimental

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

干预措施: High flow nasal oxygen (Other)

Group 2

Experimental

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

干预措施: non invasive BIPAP (Other)

结局指标

主要结局

treatment success

时间窗: 48 hours

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

Treatment failure

时间窗: 48 hours

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

treatment success

时间窗: 48 hours

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

Treatment failure

时间窗: 48 hours

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

次要结局

  • Assess the patient's comfort and tolerance to the technique used.(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)
  • Record any possible complications related to treatment. Record any possible complications related to treatment. Record any possible complications(48 hours)
  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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