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CompletedNCT03335345AMBROISIEUpdated Mar 10, 2022

Non-inferiority Study of the Pursuit of Enteral Nutrition Compared to a Strategy of Gastric Emptiness Peri-extubation. Cluster Randomized Trial

An interventional study of maintaining calorie intake and maximum gastric vacuity in Non-inferiority, in Terms of Extubation Failure, Continuation of Enteral Nutrition Before Extubation Versus Gastric Vacuity Peri-extubation, sponsored by Centre Hospitalier le Mans. Completed at 22 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-10.

Sponsored by Centre Hospitalier le Mans · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
1,148
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Approximately 50 to 60% of ICU patients are subjected to invasive mechanical ventilation-through a tracheal tube. Extubation consists of a key moment for the patient on the road to recovery (1). The extubation failure, is a major disease event. The incidence of extubation failure vary between studies between 10% and 20% of ventilated patients over 48 hours, it is therefore a significant risk including at the individual level. Ultimately, it is observed higher mortality for patients with unsuccessful extubation and this independently of their overall severity (2,3). Among the complications associated with extubation failure observed the occurrence of nosocomial pneumonia. Large-scale epidemiological data, covering nearly half of French ICUs found a risk of nosocomial pneumonia multiplied by a factor of 3 in case of extubation failure. Observing this strong association between nosocomial pneumonia and extubation failure does not presage a causal link. In all cases the onset of pneumonia probably involved in the morbidity and mortality of patients undergoing a failed extubation(4).

Prevention of inhalation may limit congestion and bronchial and lung infection, and thereby reduce the risk of extubation failure. Indeed, the primary pathophysiologic mechanism responsible for nosocomial bronchopulmonary infection is inhalation of oropharyngeal and digestive secretions (5).

This risk of inhalation during intubation motivates the implementation of fasting prior to general anesthesia for elective surgery patients. Indeed, it is recommended to respect a 6-hour fast for solids and 2 hours for liquid (water, fruit juices without pulp, tea or coffee without milk) in this situation (9).

Although the situations are very different from the context of programmed anesthesia and extubation followed by a possible emergency reintubation on failure of extubation in the context of resuscitation, fasting appears as a potential means of limit the inhalation during the period of risk posed extubation and reintubation eventual resuscitation. Nevertheless, it is doubtful of the effectiveness of the single fasting to ensure gastric emptiness during the period of extubation. Indeed, a very large proportion of patients presents the delayed gastric emptying causing prolonged gastric fluid stasis. (10).

Fasting and aspiration of gastric contents through a stomach tube has not, to our knowledge, never been rigorously evaluated in the ICU extubation.

Moreover, the setting of fasting patients is likely to induce significant side effects first and foremost, a charge extra care for paramedics. The other major effect is the calorie deficit induced potential source of infectious complications and a delay in extubation.

02

Conditions studied

  • Non-inferiority, in Terms of Extubation Failure, Continuation of Enteral Nutrition Before Extubation Versus Gastric Vacuity Peri-extubation

Keywords

  • Airway Extubation/adverse effects/ Methods
  • Nutrition
  • Ventilator Weaning/methods
  • Intensive care Unit
  • Enteral Nutrition
03

In context

Lead sponsor

Centre Hospitalier le Mans is the lead sponsor of 44 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Hospitalized patient in intensive care
  • Invasive artificial ventilation for at least 48h at the time of extubation
  • Prepyloric enteral feeding for at least 24 hours at the time of extubation
  • Age ≥ 18 years

Exclusion criteria

Exclusion Criteria:

  • tutorship or curatorship
  • Pregnant, parturient or nursing woman
  • Patient not affiliated to a social security scheme
  • Tracheotomized patient
  • Post-pyloric enteral-fed patient (naso-jejunal tube)
  • Patient already included in this study
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,148 participants (actual)

Study arms

  • Other
    maximum gastric void

    stopping enteral feeding at least 6 hours before extubation. Suction in the gastric tube (if its size permits) continuously for 6 hours before extubation.

    Other: maximum gastric vacuity

  • Other
    maintaining calorie intake

    maintaining enteral caloric intake at the same rate. No aspiration in the gastric tube

    Other: maintaining calorie intake

Interventions

  • Othermaintaining calorie intake

    Maintaining enteral caloric intake at the same rate. No aspiration in the gastric tube.

  • Othermaximum gastric vacuity

    stopping enteral feeding at least 6 hours before extubation. Suction in the gastric tube (if its caliber permits) continuously for 6 hours before extubation

06

What researchers measure

Primary outcomes

  1. reintubation within 7 days after extubation in intensive care.

    Time frame: 7 days

07

Study locations

22 sites
  • Réanimation Médicale-CHU ANGERS
    Angers, 49000, France
  • Réanimation médico-chirurgicale-CH BLOIS
    Blois, 41000, France
  • Réanimation Chirurgicale-CHU BREST
    Brest, 29200, France
  • Réanimation Médicale CHU BREST
    Brest, 29200, France
  • Réanimation polyvalente-CH CHARTRES
    Chartres, 28000, France
  • Réanimation polyvalente-CH CHOLET
    Cholet, 49280, France
  • Réanimation polyvalente-CH DREUX
    Dreux, 28100, France
  • Réanimation polyvalente-Centre Hospitalier Départemental Vendée
    La Roche-sur-Yon, 85000, France
  • Réanimation médico-chirurgicale- CH LE MANS
    Le Mans, 72000, France
  • Réanimation-CH de Pays de MORLAIX
    Morlaix, 29600, France
  • Réanimation Chirugicale 2- CHU NANTES
    Nantes, 44000, France
  • Réanimation Médicale-CHU NANTES
    Nantes, 44000, France
  • Médecine Intensive Réanimation-CH ORLEANS
    Orléans, 45000, France
  • Réanimation médico-chirurgicale-CH PARIS ST JOSEPH
    Paris, 75014, France
  • Réanimation Médicale-CHU POITIERS
    Poitiers, 86000, France
  • Réanimation et Soins Continus-CHI de CORNOUAILLE
    Quimper, 29000, France
  • Réanimation Médicale-CHU RENNES
    Rennes, 35000, France
  • Réanimation polyvalente-CH SAINT BRIEUC
    Saint-Brieuc, 22000, France
  • Réanimation polyvalente-CHG SAINT NAZAIRE
    Saint-Nazaire, 44600, France
  • Réanimation Chirurgicale-CHRU TOURS
    Tours, 37000, France
  • Réanimation Médicale-CHRU TOURS
    Tours, 37000, France
  • Réanimation-Brulés-CHU GUADELOUPE
    Pointe-à-Pitre, 97110, Guadeloupe
08

References and documents

Publications

  • Landais M, Nay MA, Auchabie J, Hubert N, Frerou A, Yehia A, Mercat A, Jonas M, Martino F, Moriconi M, Courte A, Robert-Edan V, Conia A, Bavozet F, Egreteau PY, Bruel C, Renault A, Huet O, Feller M, Chudeau N, Ferrandiere M, Rebion A, Robert A, Giraudeau B, Reignier J, Thille AW, Tavernier E, Ehrmann S; REVA network and CRICS-TriggerSEP F-CRIN research network. Continued enteral nutrition until extubation compared with fasting before extubation in patients in the intensive care unit: an open-label, cluster-randomised, parallel-group, non-inferiority trial. Lancet Respir Med. 2023 Apr;11(4):319-328. doi: 10.1016/S2213-2600(22)00413-1. Epub 2023 Jan 21. PubMed 36693402 ↗
  • Landais M, Nay MA, Auchabie J, Hubert N, Rebion A, Robert A, Giraudeau B, Reignier J, Thille AW, Tavernier E, Ehrmann S. Continuous enteral nutrition compared with a maximal gastric vacuity strategy at the time of extubation in the intensive care unit: protocol for a non-inferiority cluster randomised trial (the Ambroisie Project). BMJ Open. 2021 May 20;11(5):e041799. doi: 10.1136/bmjopen-2020-041799. PubMed 34016658 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2018 to primary completion in Dec 2020, 32 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 3, 2017
First posted
Nov 7, 2017
StartActual
Apr 5, 2018
Primary completionActual
Dec 31, 2020
CompletionActual
Dec 31, 2020
Last update
Mar 10, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03335345
Lead sponsor
Centre Hospitalier le Mans
Responsible party
Sponsor
First posted
Nov 7, 2017
Start date
Apr 5, 2018
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020
Last update
Mar 10, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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