Gastric Volume Estimation by Ultrasonography After Glucose Loaded Clear Fluid Ingestion in Fasted Adult

NCT04478435 | Completed

• 1 other identifier: FF-2018-447
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction; Pre operative gastric ultrasonography is a newly developed tool used to evaluate gastric content and volume in assessing perioperative aspiration risk and guide anaesthetic management. Gastric antrum is the most amenable and most consistently identified region for sonographic examination during assessment even in empty state. Baseline gastric secretions and clear fluids i.e: water, apple juice and tea have hypoechoeic or anechoic appearance, whilst milk, thick fluids, or suspensions will have increased echogenicity. Evaluation with sonographic assessment were found to be accurately reflective of gastric content in various studies. In this study, healthy volunteers were recruited. They will be required to fast at least 8 hours prior to baseline gastric antrum ultrasonography assessment. Following that, they will require to drink 250ml glucose loaded drinks. Repeated Ultrasound assessment will be done after 1 hour of glucose loaded drink ingestion in Group 1 and after 2 hours in Group 2. Hypothesis of the study is there will be no significant different between ultrasound assessment between this 2 groups.

Conditions

Healthy Participants

Keywords

gastric antrum ultrasonography; Gastric volume estimation; aspiration risk

Outcome Measures

Primary Outcomes (2)

• Gastric volume assessment

  Gastric volume can be calculated with gastric antrum measurement

  1 hour after intervention

• Gastric volume assessment

  Gastric volume can be calculated with gastric antrum measurement

  2 hours after intervention

Other Outcomes (1)

• Baseline gastric volume

  Baseline

Study Arms (2)

1 Hour post intervention

ACTIVE COMPARATOR

Ultrasound assessment done 1 hour after ingestion of glucose loaded drink

Other: glucose loaded clear fluid

2 hours post intervention

PLACEBO COMPARATOR

Ultrasound assessment done 2 hour after ingestion of glucose loaded drink

Other: glucose loaded clear fluid

Interventions

glucose loaded clear fluid OTHER

Ultrasound assessment of gastric antrum is done at different time interval following glucose loaded clear fluid ingestion

1 Hour post intervention; 2 hours post intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA 1 \& 2

You may not qualify if:

• Upper gastrointestinal pathology such as hiatus hernia, oesophageal cancer
• Prior surgery to upper GI
• On medication that may affect gastric emptying time
• Pregnancy

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

Pusat Perubatan Universiti Kebangsaan Malaysia

Kuala Lumpur, Wp, 5600, Malaysia

Location

Related Publications (4)

• Warner MA, Warner ME, Weber JG. Clinical significance of pulmonary aspiration during the perioperative period. Anesthesiology. 1993 Jan;78(1):56-62. doi: 10.1097/00000542-199301000-00010.

  PMID: 8424572 RESULT

• Read MS, Vaughan RS. Allowing pre-operative patients to drink: effects on patients' safety and comfort of unlimited oral water until 2 hours before anaesthesia. Acta Anaesthesiol Scand. 1991 Oct;35(7):591-5. doi: 10.1111/j.1399-6576.1991.tb03354.x.

  PMID: 1785235 RESULT

• Perlas A, Davis L, Khan M, Mitsakakis N, Chan VW. Gastric sonography in the fasted surgical patient: a prospective descriptive study. Anesth Analg. 2011 Jul;113(1):93-7. doi: 10.1213/ANE.0b013e31821b98c0. Epub 2011 May 19.

  PMID: 21596885 RESULT

• Kruisselbrink R, Gharapetian A, Chaparro LE, Ami N, Richler D, Chan VWS, Perlas A. Diagnostic Accuracy of Point-of-Care Gastric Ultrasound. Anesth Analg. 2019 Jan;128(1):89-95. doi: 10.1213/ANE.0000000000003372.

  PMID: 29624530 RESULT

Study Officials

• Syarifah Noor Nazihah S Masri

  PPUKM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2020
• First Posted: July 20, 2020
• Study Start: January 1, 2019
• Primary Completion: June 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 20, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)