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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02584348
Other study ID # 2013.790
Secondary ID
Status Completed
Phase N/A
First received October 21, 2015
Last updated August 26, 2016
Start date November 2013
Est. completion date November 2015

Study information

Verified date August 2016
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

Anesthesia for emergency surgery is a situation at risk of pulmonary aspiration of gastric contents. It has been previously reported that bedside two-dimensional ultrasonography can be a useful tool for anesthesiologists to determine gastric contents and volume in adults and children.

In this prospective study, preoperative qualitative ultrasound assessment of gastric contents is performed for each children admitted for emergency surgery, in order to plane in case of empty stomach an intravenous or inhalation technique induction rather than an rapid sequence induction.


Recruitment information / eligibility

Status Completed
Enrollment 146
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- Children aged from 0 to 18 years old

- Parental consent

Exclusion Criteria:

- Gastric tube contraindication

- Parental refusal

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Device:
Gastric ultrasound
Preoperative qualitative ultrasound assessment of gastric contents will be performed for each children admitted for emergency surgery

Locations

Country Name City State
France Department of paediatric anaesthesia 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 Number of adapted changes in induction technique according to ultrasound assessment of gastric contents intraoperative No
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