Critically Ill PatientsGastrICUNCT03205592
Ultrasound Assessment of Residual Gastric Content in Critically Ill Patients
An observational study of Critically Ill Patients, run by Hôpital Edouard Herriot at 3 sites in France.
Trial summary
This prospective observational study aims to assess whether ultrasound assessment of gastric content may be useful for the monitoring of the gastric residual content in critically ill patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill Patients
- What is being tested?
- Ultrasound examination of the antrum
- How many people
- 61 participants
- Where
- 3 sitesFrance
- Study dates
- 3 Jul 2017to 4 May 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients hospitalized in 3 critical care units (Groupement hospitalier Sud Lyon, Saint Etienne, Marseille)
Who may be able to join
- Critically ill patients under mechanical ventilation and enteral feeding through a gastric tube since >48 h
Who cannot join
- Digestive hemorrhage Contra-indication to prokinetic drugs Enteral feeding through jejunostomy or gastrostomy Pregnancy
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Nord
Marseille, 13015
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
CHU Saint Etienne
Saint-Etienne, 42000
About this study
This prospective observational study aims to assess whether ultrasound assessment of gastric content may be useful for the monitoring of the gastric residual content in critically ill patients
- Conditions
- Critically Ill Patients
- Being tested
- Ultrasound examination of the antrum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound examination of the antrumDiagnostic test
Ultrasound assessment of gastric content will be performed : prior to suction of gastric content through a gastric tube (method to assess the residual gastric content volume), after this suctioning of gastric content, then after reinjection of the content suctioned into the stomach (max 250 ml) and 1h30 later
What is being measured
The primary outcome is the main question the study is designed to answer.
change in antral cross sectional area measured by ultrasonography after suctioning gastric volume
Ultrasound measurement of antral area and qualitative assessment
Measured: prior to and immediately after suctioning of gastric content volume through a gastric tube
Change in antral area after administration of prokinetic drug
If aspirated gastric content volume was > 250 ml, only 250 ml will be reinjected into the stomach and a prokientic drug will be administered (current protocol in our units). Antral area will be measured prior to and 90 min after the start of the infusion
Measured: Ultrasound assessment of gastric content after reinjection of suctioned gastric content and 1h30 later (1 h after the end of the infusion of prokinetic drug)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start3 Jul 2017
- Primary completion4 May 2018
- Study completion4 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Edouard Herriot
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lionel Bouvet, Hôpital Edouard Herriot
- Investigators
- Lionel BOUVET, MD PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205592
- Sponsor's protocol ID
- L16-174
- Acronym
- GastrICU
- Status last verified
- May 2018
- First submitted
- 28 Jun 2017
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bouvet L, Zieleskiewicz L, Loubradou E, Alain A, Morel J, Argaud L, Chassard D, Leone M, Allaouchiche B; AzuRea CAR'Echo collaborative networks. Reliability of gastric suctioning compared with ultrasound assessment of residual gastric volume: a prospective multicentre cohort study. Anaesthesia. 2020 Mar;75(3):323-330. doi: 10.1111/anae.14915. Epub 2019 Dec 4.
PubMed 31802485
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Residual Gastric Content in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03205592
- Acronym / sponsor ID
- GastrICU / L16-174
- Conditions
- Critically Ill Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Hôpital Edouard HerriotUniversity, hospital or other
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- 4 May 2018 (actual)
- Study completion
- 4 May 2018 (actual)
- First posted
- 2 Jul 2017 (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 prospective observational study aims to assess whether ultrasound assessment of gastric content may be useful for the monitoring of the gastric residual content in critically ill patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients hospitalized in 3 critical care units (Groupement hospitalier Sud Lyon, Saint Etienne, Marseille)
Key inclusion criteria (1 listed)
- Critically ill patients under mechanical ventilation and enteral feeding through a gastric tube since >48 h
Key exclusion criteria (1 listed)
- Digestive hemorrhage Contra-indication to prokinetic drugs Enteral feeding through jejunostomy or gastrostomy Pregnancy
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 examination of the antrumUltrasound assessment of gastric content will be performed : prior to suction of gastric content through a gastric tube (method to assess the residual gastric content volume), after this suctioning of gastric content, then after reinjection of the content suctioned into the stomach (max 250 ml) and 1h30 later | Diagnostic test | – |
Primary outcome
change in antral cross sectional area measured by ultrasonography after suctioning gastric volume
Time frame: prior to and immediately after suctioning of gastric content volume through a gastric tube
Ultrasound measurement of antral area and qualitative assessment
Change in antral area after administration of prokinetic drug
Time frame: Ultrasound assessment of gastric content after reinjection of suctioned gastric content and 1h30 later (1 h after the end of the infusion of prokinetic drug)
If aspirated gastric content volume was > 250 ml, only 250 ml will be reinjected into the stomach and a prokientic drug will be administered (current protocol in our units). Antral area will be measured prior to and 90 min after the start of the infusion
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 7 May 2018.
- Derived from this study: PubMed 31802485Bouvet L, Zieleskiewicz L, Loubradou E, Alain A, Morel J, Argaud L, Chassard D, Leone M, Allaouchiche B; AzuRea CAR'Echo collaborative networks. Reliability of gastric suctioning compared with ultrasound assessment of residual gastric volume: a prospective multicentre cohort study. Anaesthesia. 2020 Mar;75(3):323-330. doi: 10.1111/anae.14915. Epub 2019 Dec 4.
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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.
Lionel BOUVET, MD PhD principal investigator
Hospices Civils de Lyon
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill Patients, run by Hôpital Edouard Herriot at 3 sites in France.
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 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 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
change in antral cross sectional area measured by ultrasonography after suctioning gastric volume (time frame: prior to and immediately after suctioning of gastric content volume through a gastric tube). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03205592, which also lists 1 linked publication.
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 7 May 2018.