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临床试验/CTRI/2025/08/092494
CTRI/2025/08/092494尚未招募不适用

Evaluation of USG guided Pre extubation GRV (Gastric Residual Volume) measurements in relation to NBM (Nil by Mouth) duration in critically ill adult patients on mechanical ventilation

Tata Memorial Centre1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年8月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
64
试验地点
1
主要终点
To compare grv in pts who are fed until 2hrs before Extubation having usg guided grv measured and compared with pts who are in nbm from 6hrs.

研究概览

简要总结

Majority of critically ill patients are intubated for mechanical ventilation in the icu and are enterally fed according to recent guidelines. However, no evidence-based recommendation is available regarding fasting times prior to extubation.

When an extubation is planned, patients do not always present with normal neurological status yet, and are at risk of vomiting and aspiration. Extubation may also fail and require re-intubation with similar risks. Thus, pre-operative fasting guidelines are often extrapolated to the critical care setting, aiming for an empty stomach at extubation, with perceived decreased risks of aspiration. However, the gastric and gut motility pathophysiology is significantly different in critically ill patients (frequent gastroparesis, liquid continuous feeding, etc.) compared to planned surgery patients. The extrapolation of practice validated in the later population may be inadequate. The stomach may be empty earlier than expected, leading to unnecessary prolonged fasting times. Prolonged fasting pre extubation can  predispose patient to hypoglycemic episodes, and also lead to deficit in the caloric intake over time.

Gastric ultrasound for GRV monitoring may help assessing gastric content status and the risk of aspiration prior to extubation.

Monitoring GRV involves obtaining frequent GRV measurements and employing appropriate interventions in patients with large GRVs. Gastric residual volume is an essential component of monitoring Enteral feeding to assess tolerance of feed.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Greater than 18-year-old patients .
  • Intubated on mechanical ventilation for more than 24hrs 3) Gastric enteral feeding (at least 25percent of prescribed targets ).

排除标准

  • Routine postoperative patients on ventilation for less than 24hrs 2)Difficult access to perform gastric ultra-sounding (drains, plasters, dressings etc.) 3)Unable to Mobilize to right lateral decubitus position.
  • Anatomical anomaly of the stomach (post surgery) 5)Tracheostomised patients 6)Post pyloric enteral nutrition (jejunal tube).

结局指标

主要结局

To compare grv in pts who are fed until 2hrs before Extubation having usg guided grv measured and compared with pts who are in nbm from 6hrs.

时间窗: At 24 hours

次要结局

  • To assess the incidence of aspiration pneumonia in patients post extubation determined by USG or New infiltrates on CXR at 24hrs(At 24 hours)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Shilpushp Bhosale

Tata Memorial Centre

研究点 (1)

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