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Clinical Trials/CTRI/2021/08/035894
CTRI/2021/08/035894Not yet recruitingNot Applicable

ULTRASONOGRAPHIC ESTIMATION OF GASTRIC CONTENT AND VOLUME IN PREOPERATIVE FASTING PATIENTS POSTED FOR ELECTIVE SURGERY: A PROSPECTIVE OBSERVATIONAL STUDY

Sanjay Gandhi Institute Of Trauma And Orthopedics1 site in 1 country80 target enrollmentStarted: August 30, 2021Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
80
Locations
1
Primary Endpoint
To determine any correlation between number of hours of fasting and Gastric content and volume estimation by Ultrasonography in patients posted for elective surgery.

Study Overview

Brief Summary

Perioperative aspiration of gastric contents is a serious complication of anaesthesia and is associated with high morbidity and mortality.

It can result in severe pneumonia requiring mechanical ventilator support in up to one-third of patients with a mortality of 5%, representing up to 9% of all anaesthesia-related deaths.

The severity of the resulting respiratory compromise is thought to be related to both the volume and nature of the aspirate, with particulate matter carrying the highest risk.

Preoperative fasting guidelines help limit the risk in elective patients with minimal co-morbidities. However, fasting intervals are not applicable or reliable in urgent or emergency surgeries or for patients with

certain medical conditions.

In anaesthesiology and acute care medicine, there is a growing interest in bedside evaluation of gastric ‘fullness’ to assess pulmonary aspiration risk. With the advent of portable ultrasound machines, performing

point-of-care ultrasound has become relatively easy and feasible. Gastric ultrasound examination is finding a place as a point-of-care tool for aspiration risk assessment.

It can identify the nature of the gastric content, i.e., empty, clear fluid and solid and when clear fluid is present, its volume can be quantified.

With this we aim to determine the efficiency of Ultrasound in determining the gastric volume and content is performed and to correlate with the fasting guidelines.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients aged 18-60 yrs.
  • Patients of either gender Patients posted for elective surgery BMI >18.5 and < 34.9 ASA 1 & 2.

Exclusion Criteria

  • Patient Refusal Pregnant women Patients with Gastroesophageal reflux disease, or Antacid medication use Patients with recent Gastroesophageal bleed / Gastroesophageal surgery (Hiatal Hernia Surgery, Fundoplication, Gastrectomy etc.) Patients with chronic Renal or Hepatic Disease, Significant Cardiovascular abnormality.
  • Patients with Neuromuscular disease.
  • Patients with mental/ psychological disorder.

Outcomes

Primary Outcomes

To determine any correlation between number of hours of fasting and Gastric content and volume estimation by Ultrasonography in patients posted for elective surgery.

Time Frame: 1 day

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Sanjay Gandhi Institute Of Trauma And Orthopedics
Sponsor Class
Government medical college

Study Sites (1)

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