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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04245878
Other study ID # NGUYEN 2019-2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 17, 2019
Est. completion date October 30, 2020

Study information

Verified date March 2021
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Orotracheal extubation in resuscitation is a situation in which there is an elevated risk of inhalation. In resuscitation, enteral nutrition that is administered in a continuous flow is likely to accumulate in the stomach. Gastric motility in resuscitation patients may be impaired for many reasons: - Iatrogenic: Catecholamines, sedatives and opioids slow down the digestive system and decrease the tone of the lower esophageal sphincter - Shock, polytrauma, sepsis, pain or discomfort, or mechanical ventilation again create an alteration in gastric emptying. Enteral nutrition is commonly discontinued to manage extubation, but it is not systematic. Discontinuation leads to a decrease in caloric intake. Gastric ultrasound is a minimally invasive, reliable and promising means of monitoring that allows the stomach to be visualized directly. Studies on healthy subjects and in anaesthesia have made it possible to validate ultrasound in the context of the study of gastric content using both quantitative (including measurement of the antral area) and qualitative criteria. Measurement of the antral area was also studied in resuscitation. Antral area and gastric volume are closely related, with a correlation coefficient ranging from 0.6 to 0.91. Identifying patients at risk of inhalation by ultrasound could allow individualized enteral nutrition management prior to extubation in the resuscitation unit, and thus optimize nutritional management. The objective of the study is to identify factors associated with greated antral area in patients hospitalized in the intensive care unit. The hypothesis is that continued enteral nutrition before extubation is associated with increased gastric volume as measured by ultrasound.


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date October 30, 2020
Est. primary completion date October 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Person or next of kin/designated representative has provided his or her non-opposition - Patient in medical or surgical intensive care, admitted for an urgent medical or surgical reason and for whom extubation have been planned by the practitioner in charge of the patient Exclusion Criteria: - Person subject to legal protection (guardianship, trusteeship) - Person subject to a justice safeguard measure - Pregnant, parturient or breastfeeding woman - Minor - Anechoic patient or patient without an exploitable ultrasound window - History of gastric or esophageal surgery - Limitation of Care (LOC) order

Study Design


Related Conditions & MeSH terms


Intervention

Other:
gastric ultrasound
gastric ultrasound for measurement of the antral area

Locations

Country Name City State
France Chu Dijon Bourgogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Surface of the antral area in mm² pre-extubation
Primary Duration of enteral feeding interruption in hours pre-extubation
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