Critical IllnessNCT05526105
Gastric US in ICU Patient
A study testing Gastric Ultrasound in people with Critical Illness and Surgery, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
This is a case series study using gastric ultrasound in critically ill patients to quantify gastric residual volumes to compare the efficacy of different NPO protocols. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Critical Illness, Surgery, Aspiration Pneumonia
- What is being tested?
- Gastric Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2023to 3 Feb 2025
- Phase
- Interventional
- 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
Who may be able to join
- Patients age 18 or older, admitted to the ICU, requiring general anesthesia or sedation for a procedure with a pre-existing, cuffed endotracheal or tracheostomy tube. Most patients admitted to the ICU would be unable to consent.
Who cannot join
- Known upper gastrointestinal anatomical problem that would prevent accurate estimation of gastric volume, gastric perforation, pregnancy beyond the first trimester.
- Lack of a pre-existing, cuffed endotracheal or tracheostomy tube.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03766
About this study
Official title: Gastric Ultrasound in Critically Ill Patients for Evaluation of Gastric Volume Residuals; A Comparison of NPO Protocols
This is a case series study using gastric ultrasound in critically ill patients to quantify gastric residual volumes to compare the efficacy of different NPO protocols.
- Conditions
- Critical Illness, Surgery, Aspiration Pneumonia
- Being tested
- Gastric Ultrasound
- Keywords
- NPO Protocols, Intensive Care Unit, Gastric Ultrasound, Ultrasound, Surgical Intensive Care Unit, NPO, Nasogastric Tube, Orogastric Tube, Enteral Nutrition, Parenteral Nutrition, Gastric Residual Volume, Aspiration, Critical Illness Nutrition
- Medical subject headings
- Critical Illness, Pneumonia, Aspiration, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric UltrasoundDiagnostic test
Gastric ultrasound in the supine and right lateral decubitus position for patients going for operative intervention with a protected airway.
| Study group | Role | What they receive |
|---|---|---|
| Standard ASA NPO Protocol | Experimental | Patients will be made NPO at midnight prior to date of surgery. Receives: Diagnostic Test: Gastric Ultrasound |
| Liberal Feeding Protocol | Experimental | Patients will be fed enterally up until call to OR at which time their stomachs will be decompressed with a pre-existing gastric tube. Receives: Diagnostic Test: Gastric Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric Residual Volumes
Quantification of gastric residual volumes as measured in milliliters using antral cross-sectional areas and semi-quantitative gastric volumes using standardized grading scores.
Measured: Within one hour of operative intervention.
Secondary outcomes (3)
Comparison of two different NPO protocol populations
Comparing standard ASA NPO protocol vs liberal, feed-up-until-call to OR protocol as defined by comparison of gastric volumes (mLs).
Measured: Within four months of study completion, 16 months from study start
Peri-operative aspiration events
Number of aspiration events per number of operative interventions.
Measured: Within four months of study completion, 16 months from study start
Estimation of the amount of enteral nutrition lost prior to surgery using the different NPO protocols
Calculation of enteral nutrition held during NPO time in kilocalories.
Measured: Zero to sixteen hours prior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start3 Feb 2023
- Primary completion3 Feb 2025
- Study completion3 Feb 2025
Why it stopped: Not enough resources (time and manpower) to run study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be assigned to be NPO after midnight (standard protocol) or feed up until call to OR then decompressed (liberal protocol).
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura M. Chiang, Dartmouth-Hitchcock Medical Center
- Investigators
- Laura M Chiang, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526105
- Sponsor's protocol ID
- STUDY02001249
- Status last verified
- Oct 2026
- First submitted
- 15 Aug 2022
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Ultrasound in Critically Ill Patients for Evaluation of Gastric Volume Residuals; A Comparison of NPO Protocols
- ClinicalTrials.gov ID
- NCT05526105
- Acronym / sponsor ID
- STUDY02001249
- Conditions
- Critical Illness, Surgery, Aspiration Pneumonia
- Keywords
- NPO Protocols, Intensive Care Unit, Gastric Ultrasound, Ultrasound, Surgical Intensive Care Unit, NPO, Nasogastric Tube, Orogastric Tube
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not enough resources (time and manpower) to run study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 3 Feb 2025 (actual)
- Study completion
- 3 Feb 2025 (actual)
- First posted
- 2 Sep 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.
This is a case series study using gastric ultrasound in critically ill patients to quantify gastric residual volumes to compare the efficacy of different NPO protocols.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be assigned to be NPO after midnight (standard protocol) or feed up until call to OR then decompressed (liberal protocol).
| Arm | Type | Receives |
|---|---|---|
| Standard ASA NPO Protocol | Experimental | Diagnostic Test: Gastric UltrasoundPatients will be made NPO at midnight prior to date of surgery. |
| Liberal Feeding Protocol | Experimental | Diagnostic Test: Gastric UltrasoundPatients will be fed enterally up until call to OR at which time their stomachs will be decompressed with a pre-existing gastric tube. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients age 18 or older, admitted to the ICU, requiring general anesthesia or sedation for a procedure with a pre-existing, cuffed endotracheal or tracheostomy tube. Most patients admitted to the ICU would be unable to consent.
Key exclusion criteria (2 listed)
- Known upper gastrointestinal anatomical problem that would prevent accurate estimation of gastric volume, gastric perforation, pregnancy beyond the first trimester.
- Lack of a pre-existing, cuffed endotracheal or tracheostomy tube.
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 in the supine and right lateral decubitus position for patients going for operative intervention with a protected airway. | Diagnostic test | Liberal Feeding Protocol, Standard ASA NPO Protocol |
Primary outcome
Gastric Residual Volumes
Time frame: Within one hour of operative intervention.
Quantification of gastric residual volumes as measured in milliliters using antral cross-sectional areas and semi-quantitative gastric volumes using standardized grading scores.
3 secondary outcomes
Comparison of two different NPO protocol populations
Time frame: Within four months of study completion, 16 months from study start
Peri-operative aspiration events
Time frame: Within four months of study completion, 16 months from study start
Estimation of the amount of enteral nutrition lost prior to surgery using the different NPO protocols
Time frame: Zero to sixteen hours prior to surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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.
Laura M Chiang, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric Ultrasound in people with Critical Illness and Surgery, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 20 Oct 2026. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Gastric Residual Volumes (time frame: Within one hour of operative intervention.). 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 20 Oct 2026.