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临床试验/CTRI/2017/09/009729
CTRI/2017/09/009729已完成不适用

COMPARISON OF VOLUME CONTROL VERSUS PRESSURE CONTROL STEPWISE ALVEOLAR RECRUITMENT MANEUVER IN ACUTE RESPIRATORY DISTRESS SYNDROME – A PROSPECTIVE OBSERVATIONAL STUDY

KMC Hospital Manipal1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2016年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
29
试验地点
1
主要终点
Compare the improvement in oxygenation (increase in PaO2/FiO2 post application of recruitment manoeuvre) with pressure control and volume control stepwise recruitment maneuvers in Acute Respiratory Distress Syndrome.

研究概览

简要总结

In our study, an effort was made to elucidate the clinical impact of stepwise alveolar recruitment maneuvers (PC – RM and VC – RM)in patients with moderate to severe ARDS classified by Berlin’s. Our results suggest that there is no significant difference between the two modes of recruitment maneuvers in improving oxygenation, occurrence of complications, hospital days, ventilator days and survival rate.

In total, 29 patients were enrolled over a period of 7 months and evaluated during recruitment maneuver. A total number of 16 (59%) subjects received PC – RM and 11 (41%) subjects received VC – RM. In the demographic and diagnostic variables age and the SOFA score was significantly different between PC – RM and VC – RM group.

The change in PaO2/FiO2 ratio from baseline to 30 minutes post recruitment showed statistically significant improvement in both the groups. In our study, post recruitment maneuver, no complications occurred. We find no difference in mortality between the 2 modes of recruitment. Possible factors that may explain this finding is that similar baseline characteristics such as severity of ARDS, and APACHE II score on the day of ICU admission.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •All adult patients with moderate or severe stage of ARDS who requires invasive mechanical ventilation.

排除标准

  • •Patients age < 18 years
  • •Pregnant women
  • •Neurosurgical patients
  • •Thoracic surgery patients
  • •Patients with bronchopulmonary fistula
  • •Patients with chest trauma (including lung contusion, hemothorax, or pneumothorax) History of severe chronic obstructive pulmonary disease (had bullae or blebs visible on chest radiograph)
  • •Patients who are haemodynamically unstable.
  • •Haemodynamic instability as defined by an increase in heart rate by more than 20 beats/minute from baseline, bradycardia < 50 beats per minute; drop in systolic blood pressure exceeding 20 mm Hg from the baseline.
  • •Desaturation (decrease by > 5% SpO2) from baseline on pulse oximetry.

结局指标

主要结局

Compare the improvement in oxygenation (increase in PaO2/FiO2 post application of recruitment manoeuvre) with pressure control and volume control stepwise recruitment maneuvers in Acute Respiratory Distress Syndrome.

时间窗: 30 minutes after application of recruitment maneuver

次要结局

  • Complications that can occur during application of RM compared among PCV – RM group and VCV – RM group(COMPLICATIONS: WITHIN 1 HOUR)

研究者

发起方
KMC Hospital Manipal
申办方类型
Private medical college

研究点 (1)

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