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

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.

Study Overview

• Status: Completed
• Conditions: Non-inferiority, in Terms of Extubation Failure, Continuation of Enteral Nutrition Before Extubation Versus Gastric Vacuity Peri-extubation
• Intervention / Treatment: Other: maximum gastric vacuity; Other: maintaining calorie intake

• Study Type: Interventional
• Enrollment (Actual): 1148
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; stopping enteral feeding at least 6 hours before extubation. Suction in the gastric tube (if its caliber permits) continuously for 6 hours before extubation
Other: maintaining calorie intake; maintaining enteral caloric intake at the same rate. No aspiration in the gastric tube	Other: maintaining calorie intake; Maintaining enteral caloric intake at the same rate. No aspiration in the gastric tube.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
reintubation within 7 days after extubation in intensive care.	7 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier le Mans

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: November 3, 2017
• First Submitted That Met QC Criteria: November 6, 2017
• First Posted (Actual): November 7, 2017

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Nutrition; Enteral Nutrition; Airway Extubation/adverse effects/ Methods; Ventilator Weaning/methods; Intensive care Unit
• Other Study ID Numbers: CHM-2016/S3/07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No