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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05181904
Other study ID # 69HCL21_1249
Secondary ID 2021-A03130-41
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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