FastingNCT05272332
Gastric Ultrasound Prior to Extubation
An observational study of Fasting, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Fasting
- What is being tested?
- Gastric ultrasound
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Sep 2020to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mechanically ventilated patients in the ICU who had been on enteral feeding via nasogastric tube, fasted for extubation
Who may be able to join
- over 18 years of age,
- mechanically ventilated patients in the ICU,
- intubated with endotracheal
- enteral feeding for over 6 hours before fasting
Who cannot join
- BMI > 40, pregnant, fine bore nasogastric tube, mechanical obstruction to gastric emptying, history of upper GI surgeries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serial Ultrasound Assessment of Gastric Volume in Mechanically Ventilated Patients Fasted Prior to Extubation: a Prospective Observational Study
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.
- Conditions
- Fasting
- Being tested
- Gastric ultrasound
- Keywords
- Gastric ultrasound, Gastric emptying
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric ultrasoundDiagnostic test
Gastric ultrasound upon fasting, after 4 hours, and after nasogastric aspiration, to estimate gastric volume
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Over 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start30 Sep 2020
- Primary completion31 Aug 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esther Tang, Prince of Wales Hospital, Shatin, Hong Kong
- Investigators
- Esther Tang, Principal investigator, Prince of Wales Hospital, Shatin, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272332
- Sponsor's protocol ID
- CREC Ref. No. 2020.311
- Status last verified
- Feb 2024
- First submitted
- 28 Feb 2022
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Ultrasound Assessment of Gastric Volume in Mechanically Ventilated Patients Fasted Prior to Extubation: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05272332
- Acronym / sponsor ID
- CREC Ref. No. 2020.311
- Conditions
- Fasting
- Keywords
- Gastric ultrasound, Gastric emptying
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong KongUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated patients in the ICU who had been on enteral feeding via nasogastric tube, fasted for extubation
Key inclusion criteria (4 listed)
- over 18 years of age,
- mechanically ventilated patients in the ICU,
- intubated with endotracheal
- enteral feeding for over 6 hours before fasting
Key exclusion criteria (1 listed)
- BMI > 40, pregnant, fine bore nasogastric tube, mechanical obstruction to gastric emptying, history of upper GI surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric ultrasoundGastric ultrasound upon fasting, after 4 hours, and after nasogastric aspiration, to estimate gastric volume | Diagnostic test | – |
Primary outcome
Difference in gastric volume before and after 4 hours of fasting
Time frame: Over 4 hours
Ultrasound measurement of gastric antrum dimenstions (antero-posterior and cranio-caudal dimensions) before and after 4 hours of fasting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Fasting
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
RecruitingPhase 2
FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM)
Dermatomyositis (DM), Juvenile Dermatomyositis (JDM)
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
Recruiting
Environmental Harm Menu Labels and Overall Dietary Quality
Food Choices
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther Tang principal investigator
Prince of Wales Hospital, Shatin, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fasting, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in gastric volume before and after 4 hours of fasting (time frame: Over 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.