Clinical trial NCT05181904: Gastric Content Ultrasound Monitoring Prior to Extubation in Critically Ill Children
Official title: Gastric Content Ultrasound Monitoring Prior to Extubation in Critically Ill Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fasting
Pediatric ALL
Aspiration
Keywords: Fasting
Extubation
Pediatric critical care
Gastric ultrasound
Aspiration
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 45
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of critically ill children presenting with a full stomach 6 hours after enteral feeding interruption for planned extubation
timeFrame: 12 hours following the inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Paediatric intensive care Unit - Hopital Femme Mère Enfant - Hospices Civils de Lyon
Study officials:
References: