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Clinical Trials/CTRI/2022/04/041851
CTRI/2022/04/041851Not yet recruitingNot Applicable

Ultrasonographic estimation of preoperative gastric volume in patients following overnight fasting and those allowed oral fluids until 2 hours before surgery

DR NANDINI V RAJ1 site in 1 country30 target enrollmentStarted: April 20, 2022Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
To measure residual gastric volume in patients following overnight fasting and those allowed oral fluids until 2 hours before surgery by gastric ultrasonography

Study Overview

Brief Summary

PULMONARY ASPIRATION OF GASTRIC CONTENTS IS ONE OF THE MOST SERIOUS COMPLICATIONS OF ANAESTHESIA, ASSOCIATED WITH HIGH MORBIDITY AND MORTALITY. IT CAN RESULT IN SEVERE PNEUMONIA REQUIRING MECHANICAL VENTILATOR SUPPORT IN ONE THIRD OF PATIENTS. EXTRAPOLATION OF PREVIOUS STUDIES REPORTED THAT CRITICAL VOLUME FOR SEVERE ASPIRATION IN ADULT HUMANS COULD BE BETWEEN 25-50 ML(0.4-0.8ML/KG). THEREFORE IT WOULD OF INTEREST TO PERFORM AN EASY NON INVASIVE BEDSIDE TEST TO HELP THE PHYSICIAN IN THE ASSESSMENT OF VOLUME OF GASTRIC CONTENTS. WITH THE ADVENT OF PORTABLE ULTRASOUND MACHINE, GASTRIC ULTRASOUND IS FINDING A PLACE AS A POINT-OF-CARE TOOL FOR ASPIRATION RISK ASSESSMENT. VARIOUS PREVIOUS STUDIES PERFORMED ON VOLUNTEERS SUGGESTED THAT THE MEASUREMENT OF ANTRAL CROSS SECTIONAL AREA IS A USEFUL NON INVASIVE TEST TO DETERMINE GASTRIC CONTENTS AND VOLUME. HENCE THIS PROSPECTIVE OBSERVATIONAL STUDY WILL BE CONDUCTED TO EVALUATE THE VOLUME OF GASTRIC CONTENTS IN PATIENTS FOLLOWING OVERNIGHT FASTING AND THOSE ALLOWED ORAL FLUIDS UNTIL 2 HOURS BEFOERE ELECTIVE SURGERY AS ASSESSED BY ULTRASONOGRAPHIC MEASUREMENT OF ANTRAL AREA.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • PATIENTS AGED BETWEEN 18-50 YEARS POSTED FOR ELECTIVE SURGERIES 2)ASA GRADE I AND II PATIENTS.

Exclusion Criteria

  • PATIENT REFUSAL 2)PATIENTS TAKING ANTACIDS,H2 RECEPTOR BLOCKERS,OPIOID ANALGESICS,METOCLOPRAMIDE 3)PATIENTS WITH A HISTORY OF ANY GASTROINTESTINAL DISORDER,DIABETES MELLITUS 4)PREGNANT WOMEN.

Outcomes

Primary Outcomes

To measure residual gastric volume in patients following overnight fasting and those allowed oral fluids until 2 hours before surgery by gastric ultrasonography

Time Frame: Gastric volume assessment by gastric ultrasonography will be done just before the patient is taken up for surgery in the pre-operative care unit

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
DR NANDINI V RAJ
Sponsor Class
Other [self]

Study Sites (1)

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