ExtubationNUTRIGUSNCT04245878
Interest of a Period of Fasting Before Extubation in Resuscitation Patients
An observational study of Extubation and Intensive Care, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extubation, Intensive Care
- What is being tested?
- gastric ultrasound
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- 17 Dec 2019to 30 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intensive care patients receiving respiratory assistance by mechanical ventilation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of a Period of Fasting Before Extubation in Resuscitation Patients: a Prospective Observational Study
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.
Read more
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
- Being tested
- gastric ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric ultrasoundOther
gastric ultrasound for measurement of the antral area
| Study group | Role | What they receive |
|---|---|---|
| intensive care unit inpatient | Inpatient intubated resuscitation patient with a scheduled extubation Receives: Other: gastric ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface of the antral area in mm²
Measured: pre-extubation
Duration of enteral feeding interruption in hours
Measured: pre-extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start17 Dec 2019
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ExtubationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245878
- Sponsor's protocol ID
- NGUYEN 2019-2
- Acronym
- NUTRIGUS
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2020
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34743035
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of a Period of Fasting Before Extubation in Resuscitation Patients: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04245878
- Acronym / sponsor ID
- NUTRIGUS / NGUYEN 2019-2
- Conditions
- Extubation, Intensive Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 29 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intensive care unit inpatient | – | Other: gastric ultrasoundInpatient intubated resuscitation patient with a scheduled extubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care patients receiving respiratory assistance by mechanical ventilation
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gastric ultrasoundgastric ultrasound for measurement of the antral area | Other | intensive care unit inpatient |
Primary outcome
Surface of the antral area in mm²
Time frame: pre-extubation
Duration of enteral feeding interruption in hours
Time frame: pre-extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Results publication: PubMed 34743035Nguyen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extubation and Intensive Care, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surface of the antral area in mm² (time frame: pre-extubation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04245878, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.