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临床试验/NCT03024658
NCT03024658已完成不适用

Single Minute of Positive End Expiratory Pressure at the Time of Induction: Effect on Arterial Blood Gases and Hemodynamics in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery

Sri Aurobindo Institute of Medical Sciences0 个研究点目标入组 70 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
主要终点
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction

研究概览

简要总结

Background: Positive end expiratory pressure (PEEP) at the time of induction increases oxygenation by preventing lung atelectasis. However, PEEP may not prove beneficial in all cases. Factors affecting the action of PEEP have not been elucidated well and remain controversial. Pulmonary vasculature has direct bearing on the action of PEEP as has been proven in previous studies. Thus this study was planned to evaluate the action of PEEP on the basis of pulmonary artery systolic pressure (PASP) which is non invasive and easily measured by trans-thoracic echocardiography.

Methodology: This Randomized prospective study comprised of 70 morbidly obese patients, ASA grade II or III, aged 20-65 years with BMI > 40kg/m2, scheduled for elective laparoscopic bariatric surgery. Ten patients had to be excluded. Thus a total of 60 patients participated in the study. Thirty patients received no PEEP at the time of induction while other 30 patients were given a PEEP of 10cm of H2O. Serial ABG samples were taken pre operatively, at the time of intubation, 5 min after intubation and 10 min after intubation. Patients were then divided into four groups on the basis of PASP value of ≤ 30 mm Hg with and without PEEP or > 30 mm Hg

详细描述

This prospective study was conducted in the Department Of Anaesthesiology& Critical Care, Sri Aurobindo Institute of Medical Sciences & P.G. Institute and Mohak Hospitals, Indore, over a period of one year. Seventy morbidly obese patients, ASA grade II or III, aged 20-65 years with BMI > 40kg/m2, scheduled for elective laparoscopic bariatric surgery were selected and a written informed consent was obtained. All the recruited patients underwent 2D-trans-thoracic echocardiography and PASP was recorded. Echocardiography was performed by same cardiologist as this measurement is operator dependent. Patients who denied consent, those undergoing Emergency and/or open surgery and those requiring more than 2 attempts for intubation were excluded.

Arterial line was inserted pre operatively and ABG sample was taken and hemodynamic parameter recording done while the patient was breathing room air. Both groups were pre-oxygenated for 3 minutes with 100% Oxygen. Standard procedure was used for induction of anesthesia in all the patients. No premedication was given. All the patients were induced with i.v. Glycopyrolate (0.005-0.01 mg/kg), i.v. Fentanyl (2µg/kg) and i.v. Propofol. Once the patient became unresponsive to verbal commands, Succinylcholine was then administered in a dose of 1- 1.5 mg/ kg. Mechanical ventilation was started with 100% oxygen. A PEEP of 10 cm H2O was applied using four hand technique in Study group while the control group received no PEEP. After one minute endotracheal intubation was done. PEEP was continued in study group after intubation.

Arterial blood gas (ABG) analysis and hemodynamic parameters were recorded at following stages:

  1. Just after inflation of cuff of endotracheal tube
  2. 5 minutes post intubation
  3. 10 minutes post intubation

Patients were then again divided into four groups on the basis of PASP:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients recruited were
  • Anesthesia society of Anesthesiologist (ASA) physical status l, II or III,
  • Aged 20-65 years
  • BMI > 40kg/m2
  • scheduled for elective laparoscopic bariatric surgery

排除标准

  • Patients who denied consent
  • Did not fulfill the inclusion criteria,
  • patients undergoing Emergency and/or open surgery
  • Patients requiring more than 2 attempts for intubation

结局指标

主要结局

effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction

时间窗: Diastolic BP in mm Hg was recorded ten minutes post intubation

Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation

effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia

时间窗: Diastolic BP in mm Hg was recorded from ABG preoperatively and taken as baseline value

Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater

次要结局

  • Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters(ABG and hemodynamic parameters were recorded ten minutes post intubation)

研究者

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

Dr. Dipti Saxena

Associate Professor, Anaesthesiology

Sri Aurobindo Institute of Medical Sciences

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