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临床试验/NCT03526003
NCT03526003Unknown不适用

Effect of Position and Pneumoperitoneum on Respiratory Mechanics and Transpulmonary Pressure During Laparoscopic Surgery

Rambam Health Care Campus0 个研究点目标入组 20 人开始时间: 2018年7月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
主要终点
Changes in esophageal pressure

研究概览

简要总结

This study is an observational study measuring the esophageal pressure in anesthetized surgical patient undergoing changes in posture and pneumoperitoneum

详细描述

The study is a prospective observational study. Following approval by the Institutional Review Board, the study will be performed in a prospective, longitudinal cohort manner. Patients scheduled for elective laparoscopic surgery aged between 20 and 60 years will be included. Each participant signed an informed consent. Exclusion criteria included respiratory pathology, a body mass index lower than 18 or higher than 40 kg/m2, esophageal pathology and previous esophageal or pulmonary operation.

Following induction of anesthesia using fentanyl 2-5 microgram/kg, propofol 1-3 mg/kg and muscle relaxation with rocuronium 0.6-0.8 mg/kg, the trachea will be intubated using a 7-8 mm ID endotracheal tube. Mechanical ventilation in a volume controlled mode with a tidal volume 6-8 ml/kg and a PEEP of 5 cm of water will be initiated at a rate of 12-16 breaths per minute using an anesthesia machine (Fabius GS Premium, Drägerwerk AG & Co. KGaA, Lübeck, Germany). Balanced general anesthesia will be maintained by sevoflurane and fentanyl.

Esophageal balloon catheter will be placed according to manufacturer instructions 9. In brief, the stomach will be decompressed and suctioned with an 18 F orogastric tube. This tube will be also utilized to estimate the depth of the lower esophageal sphincter, a measure that will be corroborated with external simulation of the approximate distance from the gastric opening to the nares. A lubricated 86 cm long closed-tip catheter with a 9.5 cm long balloon catheter at its distal end will be gently inserted via one nostril and advanced into the esophagus. The calculated depth aiding in positioning the balloon at the lower third of the thoracic cavity at about 10 cm above the lower esophageal sphincter, as guided by catheter markings, will be the product of patient height x 0.288. This location had been verified by the external measurements at described above. An extension tubing will be attached to the Y piece at the proximal ending of the catheter and connected to a syringe and a pre-calibrated pressure transducer via a 3-way stopcock. One ml of air will be injected into the balloon so that it became semi inflated, and the tracing on the pressure monitor will be adjusted with additional small amounts of air until no flattening or damping will be noted in the pressure waveform. When properly positioned, the catheter will be secured with tape to prevent movement or extubation.

Esophageal pressure will be continuously measured via a calibrated pressure transducer system (Art-Line ,BioMetrix, Kiryat Mada, Jerusalem, Israel) connected to a patient monitor (Datex AS/3, Datex Ohmeda Medical Equipment, GE Healthcare, USA) and recorded using a designated computer software.

Esophageal pressure will be documented with the patient at horizontal position, and with the head up, operating table elevated 20 cm (anti Trendelenburg position) and head down, operating table lowill bed 20 cm (Trendelenburg position).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients scheduled for laparoscopic surgery
  • body mass index between 25 and 45

排除标准

  • pregnancy
  • contraindications for insertion of nasogastric tube

结局指标

主要结局

Changes in esophageal pressure

时间窗: From immidiatly after induction of general anesthesia and mechanical ventilation to 10 minutes after initiation of pneumoperitoneum

Effect of posture and pneumoperitoneum on esophageal pressure

次要结局

未报告次要终点

研究者

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

Dr. Amit Lehavi MD FANZCA

Director of Pediatric Anesthesia

Rambam Health Care Campus

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