FastingGastrExtubNCT05181904
Gastric Content Ultrasound Monitoring Prior to Extubation in Critically Ill Children
An observational study of Fasting and Pediatric ALL, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Nearly half of critically ill children are intubated and enterally fed according to recent guidelines. However, no evidence-based recommendation are available regarding fasting times prior to extubation. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Fasting, Pediatric ALL, Aspiration
- What is being tested?
- Gastric ultrasound
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2022to 24 Oct 2024
- 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 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: 45 critically ill children (meeting inclusion criteria and respecting exclusion criteria), will be recruited in a single pediatric intensive care unit, if they are intubated and enterally fed on a gastric tube.
Who may be able to join
- 0 to 17 year old children admitted to pediatric intensive care unit
- intubated (oral or nasal tracheal tube)
- gastric enteral feeding affording at least 25% of the nutritional target (estimated with Schofield equations)
- No opposition from one of the 2 parents (or legal representatives)
Who cannot join
- anatomical anomaly of the stomach location (e.g. post surgery)
- Difficult access to perform gastric ultra-sounding (drains, plasters, dressings etc.)
- mobilization to right lateral decubitus at risk
Trial locations and contacts
1 site in 1 country.
France1 site
Paediatric intensive care Unit - Hopital Femme Mère Enfant - Hospices Civils de Lyon
Bron, 69500
About this study
Nearly half of critically ill children are intubated and enterally fed according to recent guidelines. However, no evidence-based recommendation are available regarding fasting times prior to extubation.
When an extubation is planned, children do not always present with normal neurological status yet, and are at risk of vomiting and aspiration. Extubation may also fail and require re-intubation with similar risks. Thus, pre-operative fasting guidelines are often transposed to the paediatric critical care setting, aiming for an empty stomach at extubation, with perceived decreased risks of aspiration. However, the gastric and gut motility pathophysiology is significantly different in critically ill children (frequent gastroparesis, liquid continuous feeding, etc.) compared to planned surgery children. The extrapolation of practice validated in the latter population may be inadequate. The stomach may be empty more or less rapidly than expected, leading to unnecessary prolonged fasting times or inappropriately short fasting times respectively.
Read more
Gastric ultrasounding monitoring may help assessing gastric content prior to extubation.
Investigators hypothesise gastric content clearance may be different in critically ill children prior to extubation, compared to pre-operative paediatric guidelines for elective surgery.
- Conditions
- Fasting, Pediatric ALL, Aspiration
- Being tested
- Gastric ultrasound
- Keywords
- Fasting, Extubation, Pediatric critical care, Gastric ultrasound, Aspiration
- Medical subject headings
- Fasting, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric ultrasoundOther
Assessment of gastric content with gastric ultrasound monitoring: gastric ultrasounds will be performed in eligible children, when enteral feeding is stopped for planned extubation, and repeated 6 hours after, at extubation and every hour between feeding interruption and extubation. The stomach will be classified as empty or full according to PERLAS criteria. In total, 8 gastric ultrasounds will be performed over a period of 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill children ready for extubation | Children admitted to a paediatric intensive care unit, invasively ventilated and intubated, enterally fed and presenting with a clinical condition allowing for extubation. 45 children will be included. Receives: Other: Gastric ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of critically ill children presenting with a full stomach 6 hours after enteral feeding interruption for planned extubation
Percentage of critically ill children presenting with a full stomach (according to PERLAS criteria) 6 hours after enteral feeding interruption for planned extubation. Gastric emptiness is assessed with gastric ultrasounding, depicting gastric content (empty versus full). Antral diameter will also be measured and gastric volume will be calculated to allow classifying gastric content according to PERLAS criteria.
Measured: 12 hours following the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start1 Apr 2022
- Primary completion24 Oct 2024
- Study completion24 Oct 2024
Why it stopped: Patient enrollment difficulties
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.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181904
- Sponsor's protocol ID
- 69HCL21_1249
- Other IDs
- 2021-A03130-41
- Acronym
- GastrExtub
- Status last verified
- Jan 2026
- First submitted
- 20 Dec 2021
- Last updated
- 15 Jan 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 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Content Ultrasound Monitoring Prior to Extubation in Critically Ill Children
- ClinicalTrials.gov ID
- NCT05181904
- Acronym / sponsor ID
- GastrExtub / 69HCL21_1249
- Conditions
- Fasting, Pediatric ALL, Aspiration
- Keywords
- Fasting, Extubation, Pediatric critical care, Gastric ultrasound, Aspiration
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Patient enrollment difficulties
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 10 Jan 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.
Nearly half of critically ill children are intubated and enterally fed according to recent guidelines. However, no evidence-based recommendation are available regarding fasting times prior to extubation.
When an extubation is planned, children do not always present with normal neurological status yet, and are at risk of vomiting and aspiration. Extubation may also fail and require re-intubation with similar risks. Thus, pre-operative fasting guidelines are often transposed to the paediatric critical care setting, aiming for an empty stomach at extubation, with perceived decreased risks of aspiration. However, the gastric and gut motility pathophysiology is significantly different in critically ill children (frequent gastroparesis, liquid continuous feeding, etc.) compared to planned surgery children. The extrapolation of practice validated in the latter population may be inadequate. The stomach may be empty more or less rapidly than expected, leading to unnecessary prolonged fasting times or inappropriately short fasting times respectively.
Gastric ultrasounding monitoring may help assessing gastric content prior to extubation.
Investigators hypothesise gastric content clearance may be different in critically ill children prior to extubation, compared to pre-operative paediatric guidelines for elective surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill children ready for extubation | – | Other: Gastric ultrasoundChildren admitted to a paediatric intensive care unit, invasively ventilated and intubated, enterally fed and presenting with a clinical condition allowing for extubation. 45 children will be included. |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 45 critically ill children (meeting inclusion criteria and respecting exclusion criteria), will be recruited in a single pediatric intensive care unit, if they are intubated and enterally fed on a gastric tube.
Key inclusion criteria (4 listed)
- 0 to 17 year old children admitted to pediatric intensive care unit
- intubated (oral or nasal tracheal tube)
- gastric enteral feeding affording at least 25% of the nutritional target (estimated with Schofield equations)
- No opposition from one of the 2 parents (or legal representatives)
Key exclusion criteria (3 listed)
- anatomical anomaly of the stomach location (e.g. post surgery)
- Difficult access to perform gastric ultra-sounding (drains, plasters, dressings etc.)
- mobilization to right lateral decubitus at risk
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 ultrasoundAssessment of gastric content with gastric ultrasound monitoring: gastric ultrasounds will be performed in eligible children, when enteral feeding is stopped for planned extubation, and repeated 6 hours after, at extubation and every hour between feeding interruption and extubation. The stomach will be classified as empty or full according to PERLAS criteria. In total, 8 gastric ultrasounds will be performed over a period of 12 hours. | Other | Critically ill children ready for extubation |
Primary outcome
Percentage of critically ill children presenting with a full stomach 6 hours after enteral feeding interruption for planned extubation
Time frame: 12 hours following the inclusion
Percentage of critically ill children presenting with a full stomach (according to PERLAS criteria) 6 hours after enteral feeding interruption for planned extubation. Gastric emptiness is assessed with gastric ultrasounding, depicting gastric content (empty versus full). Antral diameter will also be measured and gastric volume will be calculated to allow classifying gastric content according to PERLAS criteria.
Results and safety
The study was stopped early (reason given: Patient enrollment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 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?
An observational study of Fasting and Pediatric ALL, run by Hospices Civils de Lyon at 1 site 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 15 Jan 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 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 was stopped early (reason given: Patient enrollment difficulties). Results are not available in the source record.
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?
Percentage of critically ill children presenting with a full stomach 6 hours after enteral feeding interruption for planned extubation (time frame: 12 hours following the inclusion). 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 15 Jan 2026.