Critically Ill Patients Clinical Trial
— GastrICUOfficial title:
Ultrasound Assessment of Residual Gastric Content in Critically Ill Patients
| 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 |
| Verified date | May 2018 |
| Source | Hôpital Edouard Herriot |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Nord | Marseille | |
| France | Centre Hospitalier Lyon Sud | Pierre-Bénite | |
| France | CHU Saint Etienne | Saint-Étienne |
| Lead Sponsor | Collaborator |
|---|---|
| Hôpital Edouard Herriot |
France,
| 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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