Gastric Content Ultrasound Monitoring Prior to Extubation in Critically Ill Children (GastrExtub)

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 Overview

• Status: Recruiting
• Conditions: Pediatric ALL; Fasting; Aspiration
• Intervention / Treatment: Other: Gastric ultrasound

• Study Type: Observational
• Enrollment (Estimated): 45

Contacts and Locations

• Study Contact: Name: Frédéric VALLA; Phone Number: +33 04 72 12 97 35; Email: Frederic.valla@chu-lyon.fr
• Study Contact Backup: Name: Florent BAUDIN; Phone Number: +33 04 72 12 97 35; Email: Florent.baudin@chu-lyon.fr

Study Locations

• France
  • Bron, France, 69500
    • Recruiting
    • Paediatric intensive care Unit - Hopital Femme Mère Enfant - Hospices Civils de Lyon
    • Contact: Frédéric VALLA; Phone Number: +33 04 72 12 97 35; Email: Frederic.valla@chu-lyon.fr
    • Principal Investigator: Frédéric VALLA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 17 years (Child)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 hours following the inclusion

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Aspiration; Gastric ultrasound; Fasting; Extubation; Pediatric critical care
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 69HCL21_1249; 2021-A03130-41 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No