Gastric Content Ultrasound Monitoring Prior to Extubation in Critically Ill Children

NCT ID: NCT05181904

Last Updated: 2026-01-15

Study Results

Results pending

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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Recruitment Status

TERMINATED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2024-10-24

Brief Summary

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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

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Conditions

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Fasting Pediatric ALL Aspiration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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)

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
Minimum Eligible Age

0 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Paediatric intensive care Unit - Hopital Femme Mère Enfant - Hospices Civils de Lyon

Bron, , France

Site Status

Countries

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France

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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