Evaluation of Antral Ultrasonography for Full Stomach Diagnosis Before Pediatric Surgical Emergencies

Gastric Content Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02936882
• Other study ID #: DAR_NCK_OMN0001
• Status: Recruiting
• Phase: N/A
• First received: October 6, 2016
• Last updated: October 14, 2016
• Start date: March 2016

Study information

• Verified date: October 2016
• Source: Hôpital Necker-Enfants Malades
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Interventional

Clinical Trial Summary

This study evaluates antral ultrasonography for the diagnosis of full stomach before surgical emergencies in pediatric population. Preoperative ultrasonographic antral evaluation is compared to peroperative gastric aspirate with nasogastric tube.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 15 Years

Eligibility

Inclusion Criteria:

• Surgical emergency procedure

• ASA I-II

Exclusion Criteria:

• Ultrasound antrum assessment not possible

• No nasogastric tube during surgery

• Vital emergency

• Patient from Critical Care Ward

• Time between ultrasound assessment and gastric content collecting up to 20min

• Child and/or Parents doesn't/don't want to participate in the study

• Personal medical history of gastric or oesophagus desease

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Full Stomach Status
• Gastric Content

Intervention

Procedure:
• Preoperative gastric ultrasonography
Before surgical emergency procedure, a preoperative antral ultrasonography is performed to assess gastric content.

Locations

Country	Name	City	State
France	Necker Enfants-Malades University Hospital - APHP	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Necker-Enfants Malades

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of gastric content aspirated throw nasogastric tube		20 min	No
Secondary	Grades as described by Perlas et al. for ultrasonographic qualitative evaluation of gastric content		20 min	No
Secondary	relationship between peroperative gastric content and ultrasonographic antrum assessment		20 min	No
Secondary	Time to perform antral ultrasonography		20 min	No
Secondary	Quality of image obtained during antral ultrasonography		20 min	No
Secondary	Child behaviour during antral ultrasonography		20 min	No
Secondary	Number of participants with exploitable antral ultrasonography		20 min	No
Secondary	Reasons for antral ultrasonography failure		20 min	No