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临床试验/CTRI/2025/06/089512
CTRI/2025/06/089512尚未招募不适用

Assessment of Diaphragmatic Function in Robotic Surgery vs Open Abdominal Surgery Under General Anaesthesia - A Prospective Observational Clinical Study.

Department of Anaesthesiology1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2025年8月29日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
112
试验地点
1
主要终点
To assess diaphragmatic function in patients undergoing robotic surgeries vs open abdominal surgeries

研究概览

简要总结

The diaphragm is the main muscle of respiration. Diaphragmatic dysfunction can be mild (weakness) or severe (with diaphragmatic paralysis). In the perioperative setting multiple factors affect the diaphragmatic function such as surgical procedure, mechanical ventilation and post operative pain. Unrecognized diaphragmatic dysfunction can result in several complications for the patient including prolonged recovery time and postoperative pulmonary complications. Over the years several methods of assessing diaphragmatic function have been used. Ultrasonography of the diaphragm has turned out to be one of the most reliable methods for bedside assessment of diaphragmatic dysfunction showing a sensitivity of 93% and specificity of 100% in neuromuscular disease. (1) Over the years surgeries are evolving to become more and more minimally invasive to increase patient comfort in the postoperative period and faster recovery. The evolution of robotic surgery comes with a challenge as it is associated with unphysiological conditions from the pneumoperitoneum created for the surgery. It results in a cephalad displacement of the diaphragm and mechanical compression of the lungs. This can be further worsened depending on the position of the patient during surgery as seen with trendelenburg position. Perioperative use of diaphragmatic US is limited due to patient position factors and has not been explored much. Through this study we aim to gain some insights on diaphragmatic dysfunction occurring in surgeries involving creation of pneumoperitoneum as compared to open surgeries.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • ASA 1&2 patients between 18-60 years of age.

排除标准

  • Pregnant women Preexisting lung and diaphragmatic dysfunction Neuromuscular disease Previous thoracic/abdominal surgery Thoracic deformity Poor imaging window Patients with ascites, hepatic/renal disease coming for high risk surgery.

结局指标

主要结局

To assess diaphragmatic function in patients undergoing robotic surgeries vs open abdominal surgeries

时间窗: Ultrasonography will be carried out prior to surgery (baseline), After completion of surgery at extubation and once subject is shifted to Post Anaesthesia Care Unit. All three assessments will be carried out the same day.

次要结局

  • To analyze the impact of age, gender, BMI, Respiratory parameters like Positive end expiratory pressure, peak airway pressures, lung compliance & surgery related parameters like pain, duration of pneumoperitoneum, duration of surgery, patient position on diaphragmatic function.(All parameters will be assessed preoperatively (baseline)and at 5 minute time intervals after intubation, at creation of pneumoperitoneum, every 30 minutes thereafter & in the PACU. All recordings will be noted on the same day of surgery.)

研究者

发起方
Department of Anaesthesiology
申办方类型
Private medical college

研究点 (1)

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