Gastric Content Ultrasound Monitoring Prior to Extubation in Critically Ill Children

Pediatric ALL Clinical Trial

— GastrExtub  

Official title:

Gastric Content Ultrasound Monitoring Prior to Extubation in Critically Ill Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05181904
• Other study ID #: 69HCL21_1249
• Secondary ID: 2021-A03130-41
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: April 1, 2026

Study information

• Verified date: April 2024
• Source: Hospices Civils de Lyon
• Contact: Frédéric VALLA
• Phone: 04 72 12 97 35
• Email: Frederic.valla[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2026
• Gender: All
• Age group: 0 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Aspiration
• Critical Illness
• Fasting
• Pediatric ALL

Intervention

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.

Locations

Country	Name	City	State
France	Paediatric intensive care Unit - Hopital Femme Mère Enfant - Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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