Clinical Trials Directory

Trials / Terminated

TerminatedNCT05181904

Gastric Content Ultrasound Monitoring Prior to Extubation in Critically Ill Children

Status
Terminated
Phase
Study type
Observational
Enrollment
34 (actual)
Sponsor
Hospices Civils de Lyon · Academic / Other
Sex
All
Age
0 Years – 17 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERGastric ultrasoundAssessment 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.

Timeline

Start date
2022-04-01
Primary completion
2024-10-24
Completion
2024-10-24
First posted
2022-01-10
Last updated
2026-01-15

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05181904. Inclusion in this directory is not an endorsement.