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临床试验/NCT03314701
NCT03314701Unknown不适用

Biphasic Intermittent Positive Airway Pressure (BIPAP) Versus Airway Pressure Release Ventilation (APRV) in Patients With Multiple Fracture Ribs

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年10月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Duration of mechanical ventilation

研究概览

简要总结

Chest trauma is the most common injury in the emergency trauma and rib fractures is the most common trauma in chest trauma. Severe rib fractures can cause paradoxical respiration and mediastinal swing, which has large effects on respiratory and circulatory system, result in acute respiratory distress syndrome. Mechanical ventilation can significantly improve the hypoxemia of the patients, correct paradoxical respiration, and treat the pulmonary atelectasis

详细描述

To compare between Biphasic Intermittent Positive Airway Pressure (BIPAP) ventilation and Airway Pressure Release Ventilation (APRV) mode in patients with multiple fracture ribs as regard:

  • Resting Energy Expenditure
  • Oxygenation
  • Stability of Physiological Status as cardiovascular activity
  • cardiac output
  • arterial blood gas measurement including [ blood PH, arterial oxygen tension, arterial carbon dioxide tension, bicarbonate level and base deficit]
  • lung and chest compliance
  • Length of intensive care unit stay.
  • The ICU mortality rate.
  • The development of major complications as nosocomial infection (hospital acquired pneumonia and ventilator associated pneumonia), major atelectasis and pneumothorax.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Isolated chest trauma patient with Multiple fracture ribs patients [ >3 ribs] who will be admitted to the surgical ICU for ventilatory support and will be expected to continue for 2 days or longer

排除标准

  • Age < 18 years old.
  • Pregnant patient.
  • Patient who will require fraction of inspired oxygen more than 0.
  • Air leak from the chest tube.
  • Patient with body temperature > 39 Celsius.
  • Acute hepatitis or severe liver disease (Child-Pugh class C).
  • Left ventricular ejection fraction less than 30%.
  • Heart rate less than 50 beats/min.
  • Second or third-degree heart block.
  • Systolic pressure < 90 mmHg despite of infusion of 2 vasopressors.
  • Patients with known endocrine dysfunction.
  • Patient with hypothermia
  • Patient on Positive end expiratory pressure more than 14 cmH2o

研究组 & 干预措施

Group 1

Active Comparator

Biphasic Intermittent Positive Airway Pressure (BIPAP) group:

Following endotracheal intubation BIPAP mode will be started with:

  • Inspiratory positive airway pressure [IPAP] at 20 cmH2O
  • Expiratory positive airway pressure [EPAP] at 5 cmH2O
  • PRESSURE SUPPORT is difference between these two pressures [IPAP]- [EPAP]
  • Mandatory pressure will be delivered at rate of 10-12/min. To produce an end tidal carbon dioxide partial pressure in the range of 35-40 mmHg hypercapnia will not be allowed

干预措施: Biphasic Intermittent Positive Airway Pressure (BIPAP) (Device)

Group 2

Active Comparator

Airway Pressure Release Ventilation (APRV) group:

  • high airway pressure (Phigh) will be set at 20 cmH2O
  • low airway pressure ( Plow) will be set at 5 cmH2O
  • the release phase setting will be adjusted to terminate the peak expiratory flow rate to ≥ 50%; release frequency of 10-12 cycles/min
  • T high at 4.5-6 seconds
  • T low at 0.5 to 0.8 second

干预措施: Airway Pressure Release Ventilation (APRV) (Device)

结局指标

主要结局

Duration of mechanical ventilation

时间窗: within one month

The total duration of ventilatory support in both groups from randomization to successful weaning (hours)

次要结局

  • Physiological dead space(within the first 48 hours)
  • Resting Energy Expenditure(within the first 48 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sayed Kaoud Abd-Elshafy

Associate Professor of Anesthesiology and Critical Care

Assiut University

研究点 (1)

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