Interest of a Period of Fasting Before Extubation in Resuscitation Patients

Intensive Care Clinical Trial

— NUTRIGUS  

Official title:

Interest of a Period of Fasting Before Extubation in Resuscitation Patients: a Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04245878
• Other study ID #: NGUYEN 2019-2
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Extubation
• Intensive Care

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