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)
Introduction Fasting is frequently imposed to patients before extubation in the intensive care unit based on scheduled surgery guidelines. This practice has never been evaluated among critically ill patients and may delay extubation, increase nursing workload and reduce caloric intake. We are hypoth...
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BMJ Publishing Group
2021-05-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/11/5/e041799.full |
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| author | Bruno Giraudeau Stephan Ehrmann Arnaud W Thille Alain Robert Mai-Anh Nay Elsa Tavernier Jean Reignier Mickael Landais Johann Auchabie Noemie Hubert Anne Rebion |
| author_facet | Bruno Giraudeau Stephan Ehrmann Arnaud W Thille Alain Robert Mai-Anh Nay Elsa Tavernier Jean Reignier Mickael Landais Johann Auchabie Noemie Hubert Anne Rebion |
| author_sort | Bruno Giraudeau |
| collection | DOAJ |
| description | Introduction Fasting is frequently imposed to patients before extubation in the intensive care unit based on scheduled surgery guidelines. This practice has never been evaluated among critically ill patients and may delay extubation, increase nursing workload and reduce caloric intake. We are hypothesising that continuous enteral nutrition until extubation represents a safe alternative compared with fasting prior to extubation in the intensive care unit.Methods and analysis Adult patients ventilated more than 48 hours and receiving pre-pyloric enteral nutrition for more than 24 hours are included in this open-label cluster randomised parallel group non-inferiority trial. The participating centres are randomised allocated to continued enteral nutrition until extubation or 6-hour fasting (with concomitant gastric suctioning when feasible) prior to extubation. The primary outcome is extubation failure (ie, reintubation within 7 days following extubation).Ethics and dissemination This study has been approved by the national ethics review board (comité de protection, des personnes Sud Mediterranée III No 2017.10.02 bis) and patients are included after informed consent. Results will be submitted for publication in peer-reviewed journals.Trial registration number ClinicalTrials.gov Registry (NCT03335345). |
| format | Article |
| id | doaj-art-aa42dd28827e4bf0ba5bb06e74e9fda0 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-05-01 |
| publisher | BMJ Publishing Group |
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| spelling | doaj-art-aa42dd28827e4bf0ba5bb06e74e9fda02025-08-20T02:18:48ZengBMJ Publishing GroupBMJ Open2044-60552021-05-0111510.1136/bmjopen-2020-041799Continuous 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)Bruno Giraudeau0Stephan Ehrmann1Arnaud W Thille2Alain Robert3Mai-Anh Nay4Elsa Tavernier5Jean Reignier6Mickael Landais7Johann Auchabie8Noemie Hubert9Anne Rebion10INSERM, U738, Paris, FranceMédecin Intensive Réanimation, CIC 1415, CRICS-TriggerSEP, Centre d`étude des pathologies respiratoires, INSERM U1100, Université de Tours, Centre Hospitalier Régional Universitaire de Tours, Tours, FranceMédecine Intensive Réanimation, Centre Hospitalier Universitaire de Poitiers, Poitiers, FranceMultipurpose Resuscitation, Le Mans Hospital Center, Le Mans, FranceMedical Intensive Care Unit, Centre Hospitalier Regional d`Orleans, Orleans, FranceClinical Investigation Center, INSERM 1415, CHRU Tours, Tours, FranceMédecine intensive réanimation, CHU Nantes, Nantes, FrancePolyvalent Resuscitation, Le Mans Hospital Center, Le Mans, FranceIntensive Care Unit, Cholet Hospital Center, Cholet, FranceCardiac Resuscitation Service, Pitié Salpêtrière University Hospital, Paris, FranceINSERM CIC 1415, Tours, FranceIntroduction Fasting is frequently imposed to patients before extubation in the intensive care unit based on scheduled surgery guidelines. This practice has never been evaluated among critically ill patients and may delay extubation, increase nursing workload and reduce caloric intake. We are hypothesising that continuous enteral nutrition until extubation represents a safe alternative compared with fasting prior to extubation in the intensive care unit.Methods and analysis Adult patients ventilated more than 48 hours and receiving pre-pyloric enteral nutrition for more than 24 hours are included in this open-label cluster randomised parallel group non-inferiority trial. The participating centres are randomised allocated to continued enteral nutrition until extubation or 6-hour fasting (with concomitant gastric suctioning when feasible) prior to extubation. The primary outcome is extubation failure (ie, reintubation within 7 days following extubation).Ethics and dissemination This study has been approved by the national ethics review board (comité de protection, des personnes Sud Mediterranée III No 2017.10.02 bis) and patients are included after informed consent. Results will be submitted for publication in peer-reviewed journals.Trial registration number ClinicalTrials.gov Registry (NCT03335345).https://bmjopen.bmj.com/content/11/5/e041799.full |
| spellingShingle | Bruno Giraudeau Stephan Ehrmann Arnaud W Thille Alain Robert Mai-Anh Nay Elsa Tavernier Jean Reignier Mickael Landais Johann Auchabie Noemie Hubert Anne Rebion 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 |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/11/5/e041799.full |
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