Enteral Nutrition Intolerance in Critically Ill PatientsNCT06557629
Reaching a Caloric Goal Using a Gastric Sonar Versus Aspiration of Gastric Contents in Critically Ill Patients Receiving Nasogastric Enteral Nutrition
A study testing Ultrasound assessment in people with Enteral Nutrition Intolerance in Critically Ill Patients, run by Meir Medical Center at 1 site in Israel.
Trial summary
Enteral nutrition intolerance, manifested in delayed gastric emptying and high gastric residual, is a common problem in critically ill patients in intensive care, with adverse consequences on patients' outcomes. A decrease in the levels of the ghrelin hormone in these patients may contribute to this problem. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Enteral Nutrition Intolerance in Critically Ill Patients
- What is being tested?
- Ultrasound assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2024to 1 Oct 2026
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Adult intensive care patients who recieve enteral nutrition via nasogastric tube -
Exclusion Criteria: 1. Pregnant patient 2. History of bariatric or other gastric surgery 3. Post-operative patients with sub-costal incision 4. Diaphragmatic hernia 5. Patients who recieve parenteral nutrition 6. Technically difficult US exam
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reaching a Caloric Goal Using a Gastric Sonar Versus Aspiration of Gastric Contents in Critically Ill Patients Receiving Nasogastric Enteral Nutrition - Randomized Controlled Trial
Enteral nutrition intolerance, manifested in delayed gastric emptying and high gastric residual, is a common problem in critically ill patients in intensive care, with adverse consequences on patients' outcomes. A decrease in the levels of the ghrelin hormone in these patients may contribute to this problem. The gastric residual test (GRV) is used to assess enteral absorption and gastric motility, but the traditional methods can lead to inaccuracy and waste of resources. In recent years, the use of ultrasound (PoCUS) to assess GRV has developed, but its effect on the rate of reaching the caloric goal has not yet been evaluated.
- Being tested
- Ultrasound assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound assessmentDiagnostic test
Ultrasound assessment of gastric residual volume
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound group | Experimental | Assessment of gastric residual volume via US Receives: Diagnostic Test: Ultrasound assessment |
| Aspiration group | No intervention | assessment of gastric residual volume via aspiration of gastric content |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaching the daily caloric goal
To compare the daily caloric goal via gastric residual volume assessment with ultrasound vs. gastric aspiration
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Oct 2024
- Primary completion1 Oct 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral Nutrition Intolerance in Critically Ill PatientsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sara dichtwald, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557629
- Sponsor's protocol ID
- 0177-24-MMC
- Status last verified
- Oct 2026
- First submitted
- 14 Aug 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reaching a Caloric Goal Using a Gastric Sonar Versus Aspiration of Gastric Contents in Critically Ill Patients Receiving Nasogastric Enteral Nutrition - Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06557629
- Acronym / sponsor ID
- 0177-24-MMC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 16 Aug 2024 (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.
Enteral nutrition intolerance, manifested in delayed gastric emptying and high gastric residual, is a common problem in critically ill patients in intensive care, with adverse consequences on patients' outcomes. A decrease in the levels of the ghrelin hormone in these patients may contribute to this problem. The gastric residual test (GRV) is used to assess enteral absorption and gastric motility, but the traditional methods can lead to inaccuracy and waste of resources. In recent years, the use of ultrasound (PoCUS) to assess GRV has developed, but its effect on the rate of reaching the caloric goal has not yet been evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound group | Experimental | Diagnostic Test: Ultrasound assessmentAssessment of gastric residual volume via US |
| Aspiration group | No intervention | –assessment of gastric residual volume via aspiration of gastric content |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Ultrasound assessmentUltrasound assessment of gastric residual volume | Diagnostic test | Ultrasound group |
Primary outcome
Reaching the daily caloric goal
Time frame: 3 days
To compare the daily caloric goal via gastric residual volume assessment with ultrasound vs. gastric aspiration
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 9 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound assessment in people with Enteral Nutrition Intolerance in Critically Ill Patients, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 9 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 Israel. 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?
Reaching the daily caloric goal (time frame: 3 days). 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 9 Oct 2026.