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

NCT ID: NCT03335345

Last Updated: 2022-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-05
• Study Completion Date: 2020-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

maximum gastric vacuity

Intervention Type: OTHER

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

maintaining calorie intake

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

Group Type: OTHER

maintaining calorie intake

Intervention Type: OTHER

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

Interventions

maintaining calorie intake

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

Intervention Type: 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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier le Mans

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Réanimation Médicale-CHU ANGERS

Angers, , France

Réanimation médico-chirurgicale-CH BLOIS

Blois, , France

Réanimation Chirurgicale-CHU BREST

Brest, , France

Réanimation Médicale CHU BREST

Brest, , France

Réanimation polyvalente-CH CHARTRES

Chartres, , France

Réanimation polyvalente-CH CHOLET

Cholet, , France

Réanimation polyvalente-CH DREUX

Dreux, , France

Réanimation polyvalente-Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, , France

Réanimation médico-chirurgicale- CH LE MANS

Le Mans, , France

Réanimation-CH de Pays de MORLAIX

Morlaix, , France

Réanimation Chirugicale 2- CHU NANTES

Nantes, , France

Réanimation Médicale-CHU NANTES

Nantes, , France

Médecine Intensive Réanimation-CH ORLEANS

Orléans, , France

Réanimation médico-chirurgicale-CH PARIS ST JOSEPH

Paris, , 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-Brulés-CHU GUADELOUPE

Pointe-à-Pitre, , Guadeloupe

Countries

France; Guadeloupe

References

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.

Reference Type: DERIVED

PMID: 36693402 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34016658 (View on PubMed)

Other Identifiers

CHM-2016/S3/07

Identifier Type: -

Identifier Source: org_study_id