Gastric Content Ultrasound Monitoring Prior to Extubation in Critically Ill Children
NCT ID: NCT05181904
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
34 participants
OBSERVATIONAL
2022-04-01
2024-10-24
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Gastric ultrasound
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.
Interventions
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Gastric ultrasound
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.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* Difficult access to perform gastric ultra-sounding (drains, plasters, dressings etc.)
* mobilization to right lateral decubitus at risk
0 Years
17 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Paediatric intensive care Unit - Hopital Femme Mère Enfant - Hospices Civils de Lyon
Bron, , France
Countries
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Other Identifiers
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2021-A03130-41
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL21_1249
Identifier Type: -
Identifier Source: org_study_id
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