| Title: |
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 |
| Authors: |
Landais, Mickaël; Nay, Mai-Anh; Auchabie, Johann; Hubert, Noemie; Frerou, Aurélien; Yehia, Aihem; Mercat, Alain; Jonas, Maud; Martino, Frédéric; Moriconi, Mikael; Courte, Anne; Robert-Edan, Vincent; Conia, Alexandre; Bavozet, Florent; Egreteau, Pierre-Yves; Bruel, Cédric; Renault, Anne; Huet, Olivier; Feller, Marc; Chudeau, Nicolas; Ferrandiere, Martine; Rebion, Anne; Robert, Alain; Giraudeau, Bruno; Reignier, Jean; Thille, Arnaud; Tavernier, Elsa; Ehrmann, Stephan |
| Contributors: |
Centre Hospitalier Le Mans (CH Le Mans); Centre Hospitalier Regional d'Orléans (CHRO); Centre Hospitalier de Cholet (CH Cholet); CHU Pitié-Salpêtrière AP-HP; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU); Centre Hospitalier Universitaire de Rennes CHU Rennes = Rennes University Hospital Pontchaillou; Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon (CHD Vendée); Centre Hospitalier Universitaire d'Angers (CHU Angers); Centre hospitalier de Saint-Nazaire; CHU Pointe-à-Pitre / Abymes Guadeloupe; Centre Hospitalier Intercommunal de Cornouaille Quimper (CHI Cornouaille Quimper ); Centre hospitalier Saint-Brieuc Paimpol Tréguier (CH Saint-Brieuc Paimpol Tréguier); Groupement Hospitalier Territoire d'Armor (GHT Armor); Hôpital Nord Laennec CHU Nantes; Hôpitaux de Chartres Chartres; Centre Hospitalier Victor Jousselin Dreux; CH Morlaix; Centre hospitalier Saint-Joseph Paris; Groupe Hospitalier Paris Saint-Joseph (hpsj); Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP); Centre Hospitalier Régional Universitaire de Brest (CHRU Brest); Optimisation des régulations physiologiques (ORPHY (EA 4324)); Université de Brest (UBO EPE)-Centre Hospitalier Régional Universitaire de Brest (CHRU Brest)-Institut Brestois Santé Agro Matière (IBSAM); Université de Brest (UBO EPE)-Université de Brest (UBO EPE); Centre Hospitalier Simone-Veil de Blois Blois (CHB); Centre Hospitalier Régional Universitaire de Tours (CHRU Tours); Centre d’Investigation Clinique CHRU Tours (CIC 1415); Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Institut National de la Santé et de la Recherche Médicale (INSERM); methodS in Patients-centered outcomes and HEalth ResEarch (SPHERE); Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Nantes Université - UFR des Sciences Pharmaceutiques et Biologiques (Nantes Univ - UFR Pharmacie); Nantes Université - pôle Santé; Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Nantes Université - pôle Santé; Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ); Centre Hospitalier Universitaire de Nantes = Nantes University Hospital (CHU Nantes); Centre hospitalier universitaire de Poitiers = Poitiers University Hospital (CHU de Poitiers La Milétrie ); CIC de Poitiers – Centre d'investigation clinique de Poitiers (CIC 1402) (CIC 1402); Université de Poitiers = University of Poitiers (UP)-Centre hospitalier universitaire de Poitiers = Poitiers University Hospital (CHU de Poitiers La Milétrie )-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM); Réseau CRICS-TRIGGERSEP Clinical Research in Intensive Care and Sepsis - TRIal Group for Global Evaluation and Research in SEPsis – Labellisé F-CRIN (French Clinical Research Infrastructure Network) (CRICS-TRIGGERSEP); Centre d’Etude des Pathologies Respiratoires Tours (CEPR - U 1100); Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM); REVA network and CRICS-TriggerSEP F-CRIN research network: Satar Mortaza, Julien Demiselle, Taoufik Sassi, Charles Delale, Julien Grouille, Anne DE Tinteniac, Marie Geslain, Herve Floch, Pierre Bailly, Laetitia Bodenes, Gwenaël Prat, Pierre Kalfon, Gaetan Badre, Cecile Jourdain, Thierry Mazzoni, Anthony LE Meur, Pierre Marie Fayolle, Anne Heron, Odile Maillet, Nelly Ledoux, Amélie Rolle, Régine Richard, Marc Valette, Marie-Ange Azais, Caroline Pouplet, Konstantinos Bachoumas, Jean Christophe Callahan, Christophe Guitton, Cedric Darreau, Montaine Lefevre, Guillaume Leloup, Mélanie Bertel, Jerome Dauvergne, Laurence Pacaud, Karim Lakhal, Maelle Martin, Charlotte Garret, Jean-Baptiste Lascarrou, Thierry Boulain, Armelle Mathonnet, Grégoire Muller, François Philippart, Marc Tran, Julien Fournier, Jean-Pierre Frat, Remi Coudroy, Delphine Chatellier, Guillaume Halley, Arnaud Gacouin, Jerome Hoff, Servane Vastal, Anne-Charlotte Tellier, Mathilde Barbaz, Charlotte Salmon Gandonniere, Emmanuelle Mercier, Walid Darwiche |
| Source: |
ISSN: 2213-2600. |
| Publisher Information: |
CCSD; Elsevier |
| Publication Year: |
2023 |
| Collection: |
Université François-Rabelais de Tours: HAL |
| Subject Terms: |
MESH: Humans; MESH: Enteral Nutrition; MESH: Airway Extubation; MESH: Respiration; Artificial; MESH: Intensive Care Units; MESH: Fasting; MESH: Treatment Outcome; [SDV]Life Sciences [q-bio] |
| Description: |
International audience ; Background: Fasting is frequently imposed before extubation in patients in intensive care units, with the aim to reduce risk of aspiration. This unevaluated practice might delay extubation, increase workload, and reduce caloric intake. We aimed to compare continued enteral nutrition until extubation with fasting before extubation in patients in the intensive care unit.Methods: We conducted an open-label, cluster-randomised, parallel-group, non-inferiority trial in 22 intensive care units in France. Patients aged 18 years or older were eligible for enrolment if they had received invasive mechanical ventilation for at least 48 h in the intensive care unit and received prepyloric enteral nutrition for at least 24 h at the time of extubation decision. Centres were randomly assigned (1:1) to continued enteral nutrition until extubation or 6-h fasting with concomitant gastric suctioning before extubation, to be applied for all patients within the unit. Masking was not possible because of the nature of the trial. The primary outcome was extubation failure (composite criteria of reintubation or death) within 7 days after extubation, assessed in both the intention-to-treat and per-protocol populations. The non-inferiority margin was set at 10%. Pneumonia within 14 days of extubation was a key secondary endpoint. This trial is now complete and is registered with ClinicalTrials.gov, NCT03335345.Findings: Between April 1, 2018, and Oct 31, 2019, 7056 patients receiving enteral nutrition and mechanical ventilation were admitted to the intensive care units and 4198 were assessed for eligibility. 1130 patients were enrolled and included in the intention-to-treat population and 1008 were included in the per-protocol population. In the intention-to-treat population, extubation failure occurred in 106 (17·2%) of 617 patients assigned to receive continued enteral nutrition until extubation versus 90 (17·5%) of 513 assigned to fasting, meeting the a priori defined non-inferiority criterion (absolute ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/36693402; PUBMED: 36693402 |
| DOI: |
10.1016/S2213-2600(22)00413-1 |
| Availability: |
https://hal.science/hal-04683372; https://hal.science/hal-04683372v1/document; https://hal.science/hal-04683372v1/file/thelancetrm-D-22-00636_Manuscrit_et_appendice-final.pdf; https://doi.org/10.1016/S2213-2600(22)00413-1 |
| Rights: |
https://about.hal.science/hal-authorisation-v1/ ; info:eu-repo/semantics/OpenAccess |
| Accession Number: |
edsbas.771288AD |
| Database: |
BASE |