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

Not Applicable

Completed

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

• Registration Number: NCT03335345
• Lead Sponsor: Centre Hospitalier le Mans

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-03
• Study First Submitted QC: 2017-11-06
• Study First Posted: 2017-11-07
• Study Start: 2018-04-05
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1148

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
maintaining calorie intake	maintaining calorie intake	maintaining enteral caloric intake at the same rate. No aspiration in the gastric tube
maximum gastric void	maximum gastric vacuity	stopping enteral feeding at least 6 hours before extubation. Suction in the gastric tube (if its size permits) continuously for 6 hours before extubation.

Primary Outcome Measures

Name	Time	Method
reintubation within 7 days after extubation in intensive care.	7 days

Trial Locations

Locations (22)

Réanimation Médicale-CHU ANGERS; 🇫🇷 Angers, France

Réanimation Médicale CHU BREST; 🇫🇷 Brest, France

Réanimation Chirurgicale-CHU BREST; 🇫🇷 Brest, France

Réanimation médico-chirurgicale-CH BLOIS; 🇫🇷 Blois, France

Réanimation polyvalente-CH DREUX; 🇫🇷 Dreux, France

Réanimation polyvalente-CH CHOLET; 🇫🇷 Cholet, France

Réanimation polyvalente-Centre Hospitalier Départemental Vendée; 🇫🇷 La Roche-sur-Yon, France

Réanimation médico-chirurgicale- CH LE MANS; 🇫🇷 Le Mans, France

Réanimation Chirugicale 2- CHU NANTES; 🇫🇷 Nantes, France

Réanimation-CH de Pays de MORLAIX; 🇫🇷 Morlaix, France

Réanimation Médicale-CHU NANTES; 🇫🇷 Nantes, France

Réanimation médico-chirurgicale-CH PARIS ST JOSEPH; 🇫🇷 Paris, France

Médecine Intensive Réanimation-CH ORLEANS; 🇫🇷 Orléans, France

Réanimation Médicale-CHU POITIERS; 🇫🇷 Poitiers, France

Réanimation et Soins Continus-CHI de CORNOUAILLE; 🇫🇷 Quimper, France

Réanimation Médicale-CHU RENNES; 🇫🇷 Rennes, France

Réanimation polyvalente-CH SAINT BRIEUC; 🇫🇷 Saint-Brieuc, France

Réanimation polyvalente-CHG SAINT NAZAIRE; 🇫🇷 Saint-Nazaire, France

Réanimation Chirurgicale-CHRU TOURS; 🇫🇷 Tours, France

Réanimation Médicale-CHRU TOURS; 🇫🇷 Tours, France

Réanimation polyvalente-CH CHARTRES; 🇫🇷 Chartres, France

Réanimation-Brulés-CHU GUADELOUPE; 🇬🇵 Pointe-à-Pitre, Guadeloupe