跳至主要内容
临床试验/CTRI/2025/02/080580
CTRI/2025/02/080580已完成不适用

Pre-operative and end-operative gastric volumes in paediatric age group patients undergoing elective and emergency surgeries: An Observational Cross-Sectional Study

AIIMS Bilaspur1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2025年2月23日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
107
试验地点
1
主要终点
To correlate pre-operative gastric volumes with preoperative fasting times

研究概览

简要总结

After obtaining parental consent, a brief history of the child (age, gender, height, weight, BMI, complaints, medical history, allergies, and recent oral intake) will be recorded. The primary investigator, guided by a supervisor, will perform gastric ultrasounds before and after surgery. An IV line will be placed either in the pre-op area or after induction in the operating room.

Using a high-frequency ultrasound probe, gastric ultrasonography will be done in two phases:

  1. Pre-op (first reading) in the holding area.
  2. End-op (second reading) in the operating room.

In the pre-op phase, the child will be placed in a supine position for ultrasound imaging of the gastric antrum to check for contents (empty, clear liquid, or solid). The child will then be turned to the right lateral decubitus (RLD) position, and the gastric volume will be measured three times using cross-sectional area (CSA) and averaged using the Perlas equation.

During the imaging, one image in the supine and RLD positions, along with one live clip in RLD.. The same process will be repeated during the end-op period.

Post-surgery, the child will be monitored in the recovery ward for up to 6 hours. Any occurrence of postoperative nausea or vomiting will be treated with ondansetron, and the event will be documented.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • (1) Paediatric patients of age group (2 years to 18 years) undergoing elective or emergency surgeries (2) Male or Female gender (3) ASA physical status I-II.

排除标准

  • (1) Patient with known abnormal upper gastrointestinal anatomy or prior upper gastrointestinal surgery or currently undergoing upper GI surgery (2) Patients with history of GERD, diabetes mellitus, renal disease (3) Patient who had vomited since most recent oral intake or upto 4hrs prior to surgery (4) Patients with wounds of the epigastrium precluding probe placement (5) Patients who will be unable to tolerate USG positioning (6) Patients who are deemed critically ill by the treating team (7) Patients whose parents refused to give consent (8) Non cooperative patient.

结局指标

主要结局

To correlate pre-operative gastric volumes with preoperative fasting times

时间窗: Before the initiation of induction of anaesthesia in the pre-op area and before reversal or arousal from anaesthesia

次要结局

  • I. To correlate pre-operative with the end-operative values of gastric volume in adequately(fasted vs non-fasted patients.)

研究者

发起方
AIIMS Bilaspur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Kartik Karan

AIIMS, Bilaspur

研究点 (1)

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