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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03205592
Other study ID # L16-174
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 3, 2017
Est. completion date May 4, 2018

Study information

Verified date May 2018
Source Hôpital Edouard Herriot
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This prospective observational study aims to assess whether ultrasound assessment of gastric content may be useful for the monitoring of the gastric residual content in critically ill patients


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date May 4, 2018
Est. primary completion date May 4, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Critically ill patients under mechanical ventilation and enteral feeding through a gastric tube since >48 h

Exclusion Criteria:

- Digestive hemorrhage Contra-indication to prokinetic drugs Enteral feeding through jejunostomy or gastrostomy Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Ultrasound examination of the antrum
Ultrasound assessment of gastric content will be performed : prior to suction of gastric content through a gastric tube (method to assess the residual gastric content volume), after this suctioning of gastric content, then after reinjection of the content suctioned into the stomach (max 250 ml) and 1h30 later

Locations

Country Name City State
France Hôpital Nord Marseille
France Centre Hospitalier Lyon Sud Pierre-Bénite
France CHU Saint Etienne Saint-Étienne

Sponsors (1)

Lead Sponsor Collaborator
Hôpital Edouard Herriot

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in antral cross sectional area measured by ultrasonography after suctioning gastric volume Ultrasound measurement of antral area and qualitative assessment prior to and immediately after suctioning of gastric content volume through a gastric tube
Primary Change in antral area after administration of prokinetic drug If aspirated gastric content volume was > 250 ml, only 250 ml will be reinjected into the stomach and a prokientic drug will be administered (current protocol in our units). Antral area will be measured prior to and 90 min after the start of the infusion Ultrasound assessment of gastric content after reinjection of suctioned gastric content and 1h30 later (1 h after the end of the infusion of prokinetic drug)
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