Interest of a Period of Fasting Before Extubation in Resuscitation Patients

NCT04245878 | Completed

• 1 other identifier: NGUYEN 2019-2
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Extubation; Intensive Care

Outcome Measures

Primary Outcomes (2)

• Surface of the antral area in mm²

  pre-extubation

• Duration of enteral feeding interruption in hours

  pre-extubation

Study Arms (1)

intensive care unit inpatient

Inpatient intubated resuscitation patient with a scheduled extubation

Other: gastric ultrasound

Interventions

gastric ultrasound OTHER

gastric ultrasound for measurement of the antral area

intensive care unit inpatient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Intensive care patients receiving respiratory assistance by mechanical ventilation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

Related Publications (1)

• Nguyen M, Drihem A, Berthoud V, Dransart-Raye O, Bartamian L, Gounot I, Guinot PG, Bouhemad B. Fasting does not guarantee empty stomach in the intensive care unit: A prospective ultrasonographic evaluation (The NUTRIGUS study). Anaesth Crit Care Pain Med. 2021 Dec;40(6):100975. doi: 10.1016/j.accpm.2021.100975. Epub 2021 Nov 4.

  PMID: 34743035 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 29, 2020
• Study Start: December 17, 2019
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

FR (1)