Gastric Content Ultrasound Monitoring Prior to Extubation in Critically Ill Children

Recruiting

• Conditions: Fasting; Pediatric ALL; Aspiration
• Interventions: Other: Gastric ultrasound

• Registration Number: NCT05181904
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-12-20
• Study First Submitted QC: 2021-12-20
• Study First Posted: 2022-01-10
• Study Start: 2022-04-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• 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)

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Exclusion Criteria

• 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Critically ill children ready for extubation	Gastric ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Percentage of critically ill children presenting with a full stomach 6 hours after enteral feeding interruption for planned extubation	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.

Trial Locations

Locations (1)

Paediatric intensive care Unit - Hopital Femme Mère Enfant - Hospices Civils de Lyon; 🇫🇷 Bron, France