NUTRIGUS: Interest of a Period of Fasting Before Extubation in Resuscitation Patients

Sponsor
Centre Hospitalier Universitaire Dijon (Other)
Overall Status
Completed
CT.gov ID
NCT04245878
Collaborator
(none)
101
1
10.4
9.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: gastric ultrasound

Study Design

Study Type:
Observational
Actual Enrollment :
101 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Interest of a Period of Fasting Before Extubation in Resuscitation Patients: a Prospective Observational Study
Actual Study Start Date :
Dec 17, 2019
Actual Primary Completion Date :
Oct 30, 2020
Actual Study Completion Date :
Oct 30, 2020

Arms and Interventions

Arm Intervention/Treatment
intensive care unit inpatient

Inpatient intubated resuscitation patient with a scheduled extubation

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

Outcome Measures

Primary Outcome Measures

  1. Surface of the antral area in mm² [pre-extubation]

  2. Duration of enteral feeding interruption in hours [pre-extubation]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Dijon Bourgogne Dijon France 21000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT04245878
Other Study ID Numbers:
  • NGUYEN 2019-2
First Posted:
Jan 29, 2020
Last Update Posted:
Mar 26, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 26, 2021