Clinical trial NCT03335345: Non-inferiority Study of the Pursuit of Enteral Nutrition Compared to a Strategy of Gastric Emptiness Peri-extubation. Cluster Randomized Trial
Official title: Non-inferiority Study of the Pursuit of Enteral Nutrition Compared to a Strategy of Gastric Emptiness Peri-extubation. Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Centre Hospitalier le Mans
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 1148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: reintubation within 7 days after extubation in intensive care.
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Réanimation Médicale-CHU ANGERS
city: Blois
country: France
facility: Réanimation médico-chirurgicale-CH BLOIS
city: Brest
country: France
facility: Réanimation Chirurgicale-CHU BREST
city: Brest
country: France
facility: Réanimation Médicale CHU BREST
city: Chartres
country: France
facility: Réanimation polyvalente-CH CHARTRES
city: Cholet
country: France
facility: Réanimation polyvalente-CH CHOLET
city: Dreux
country: France
facility: Réanimation polyvalente-CH DREUX
city: La Roche-sur-Yon
country: France
facility: Réanimation polyvalente-Centre Hospitalier Départemental Vendée
city: Le Mans
country: France
facility: Réanimation médico-chirurgicale- CH LE MANS
city: Morlaix
country: France
facility: Réanimation-CH de Pays de MORLAIX
city: Nantes
country: France
facility: Réanimation Chirugicale 2- CHU NANTES
city: Nantes
country: France
facility: Réanimation Médicale-CHU NANTES
city: Orléans
country: France
facility: Médecine Intensive Réanimation-CH ORLEANS
city: Paris
country: France
facility: Réanimation médico-chirurgicale-CH PARIS ST JOSEPH
city: Poitiers
country: France
facility: Réanimation Médicale-CHU POITIERS
city: Quimper
country: France
facility: Réanimation et Soins Continus-CHI de CORNOUAILLE
city: Rennes
country: France
facility: Réanimation Médicale-CHU RENNES
city: Saint-Brieuc
country: France
facility: Réanimation polyvalente-CH SAINT BRIEUC
city: Saint-Nazaire
country: France
facility: Réanimation polyvalente-CHG SAINT NAZAIRE
city: Tours
country: France
facility: Réanimation Chirurgicale-CHRU TOURS
city: Tours
country: France
facility: Réanimation Médicale-CHRU TOURS
city: Pointe-à-Pitre
country: Guadeloupe
facility: Réanimation-Brulés-CHU GUADELOUPE
Study officials:
References:
citation: 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.