A clinical trial to comparatively evaluate the accuracy of gastric content volume estimation by ultrasonography and endoscopic suctioning in fasting patients.
- Conditions
- Diseases of esophagus, stomach and duodenum,
- Registration Number
- CTRI/2024/08/072311
- Lead Sponsor
- Dayanand Medical college and Hospital
- Brief Summary
Pulmonary aspiration of gastric contents is one of the most dreaded complications of anesthesia. It predisposes the patients to lethal consequences secondary to lung injury from aspirated particulate matter, acid, and bacteria. Aspiration pneumonitis or Mendelson’s syndrome is a condition that occurs as a result of aspiration of very acidic sterile gastric fluid of volume >25 ml and pH <2.5 . Hence, preoperative estimation of gastric content volume with ultrasound remains a very valuable asset in assessing and reducing the perioperative risk of pulmonary aspiration.
A prospective, randomized, interventional study will be conducted on 315 ASA I-IV adult patients undergoing endoscopic procedures under mild sedation. Gastric content volume will be first assessed preoperatively with Gastric ultrasonography (GUS). Later, gastric contents will be suctioned by the endoscopist under direct vision. Data collected will be statistically correlated and analysed.
Our aim of study and primary outcome will be to evaluate the accuracy of volume estimated by ultrasonography and its quantitative correlation with gastric contents suctioned via endoscopy. The secondary outcome will be to correlate the residual gastric volume with the duration of fasting for liquids, semisolids and solids.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 315
- Age more than 18 years.
- Either Sex.
- Ability to understand the study procedures and provide informed consent.
- 5.Fasting as per ASA guidelines (2022-2023).
- 1.Age less than 18 years.
- Patients with difficulty in assessment by gastric ultrasonography.
- Patient with upper gastrointestinal bleed.
- 4.Previous lower esophageal or gastric surgery.
- Abnormal upper gastrointestinal anatomy e.g., hiatus hernia and gastric tumours etc 6.
- Gastric outlet obstruction.
- Patient taking prokinetic drugs.
- Refusal by patient.
- Non fasting patients [not following ASA guidelines (2022-2023)].
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the accuracy of volume estimated by ultrasonography and its quantitative correlation with gastric contents suctioned via endoscopy. 10 minutes
- Secondary Outcome Measures
Name Time Method To correlate the residual gastric volume with the duration of fasting for liquids, semisolids & solids. 6-8 hours
Trial Locations
- Locations (1)
Dayanand Medical college and Hospital
🇮🇳Ludhiana, PUNJAB, India
Dayanand Medical college and Hospital🇮🇳Ludhiana, PUNJAB, IndiaDr Suneet Kant KathuriaPrincipal investigator9814007622suneetkathuria@hotmail.com