NCT05272332

Brief Summary

Serial gastric ultrasound assessments to assess the effect of fasting for 4 hours on gastric volume in mechanically ventilated patients in the ICU fasted for extubation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 9, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

1.9 years

First QC Date

February 28, 2022

Last Update Submit

February 28, 2024

Conditions

Fasting

Keywords

Gastric ultrasoundGastric emptying

Outcome Measures

Primary Outcomes (1)

  • Difference in gastric volume before and after 4 hours of fasting

    Ultrasound measurement of gastric antrum dimenstions (antero-posterior and cranio-caudal dimensions) before and after 4 hours of fasting

    Over 4 hours

Interventions

Gastric ultrasoundDIAGNOSTIC_TEST

Gastric ultrasound upon fasting, after 4 hours, and after nasogastric aspiration, to estimate gastric volume

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Mechanically ventilated patients in the ICU who had been on enteral feeding via nasogastric tube, fasted for extubation

You may qualify if:

  • over 18 years of age,
  • mechanically ventilated patients in the ICU,
  • intubated with endotracheal
  • enteral feeding for over 6 hours before fasting

You may not qualify if:

  • BMI \> 40, pregnant, fine bore nasogastric tube, mechanical obstruction to gastric emptying, history of upper GI surgeries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Esther Tang

    Prince of Wales Hospital, Shatin, Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 9, 2022

Study Start

September 30, 2020

Primary Completion

August 31, 2022

Study Completion

October 31, 2022

Last Updated

March 1, 2024

Record last verified: 2024-02

Locations

HK(1)