Non-inferiority, in Terms of Extubation Failure, Continuation of Enteral Nutrition Before Extubation Versus Gastric Vacuity Peri-extubationAMBROISIENCT03335345
Non-inferiority Study of the Pursuit of Enteral Nutrition Compared to a Strategy of Gastric Emptiness Peri-extubation. Cluster Randomized Trial
A study testing maintaining calorie intake and maximum gastric vacuity in people with Non-inferiority, in Terms of Extubation Failure, Continuation of Enteral Nutrition Before Extubation Versus Gastric Vacuity Peri-extubation, run by Centre Hospitalier le Mans at 22 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-inferiority, in Terms of Extubation Failure, Continuation of Enteral Nutrition Before Extubation Versus Gastric Vacuity Peri-extubation
- What is being tested?
- maintaining calorie intake and maximum gastric vacuity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,148 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 5 Apr 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
France21 sites
Réanimation Médicale-CHU ANGERS
Angers, 49000
Réanimation médico-chirurgicale-CH BLOIS
Blois, 41000
Réanimation Chirurgicale-CHU BREST
Brest, 29200
Réanimation Médicale CHU BREST
Brest, 29200
Réanimation polyvalente-CH CHARTRES
Chartres, 28000
Réanimation polyvalente-CH CHOLET
Cholet, 49280
Réanimation polyvalente-CH DREUX
Dreux, 28100
Réanimation polyvalente-Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, 85000
Réanimation médico-chirurgicale- CH LE MANS
Le Mans, 72000
Réanimation-CH de Pays de MORLAIX
Morlaix, 29600
Réanimation Chirugicale 2- CHU NANTES
Nantes, 44000
Réanimation Médicale-CHU NANTES
Nantes, 44000
Médecine Intensive Réanimation-CH ORLEANS
Orléans, 45000
Réanimation médico-chirurgicale-CH PARIS ST JOSEPH
Paris, 75014
Réanimation Médicale-CHU POITIERS
Poitiers, 86000
Réanimation et Soins Continus-CHI de CORNOUAILLE
Quimper, 29000
Réanimation Médicale-CHU RENNES
Rennes, 35000
Réanimation polyvalente-CH SAINT BRIEUC
Saint-Brieuc, 22000
Réanimation polyvalente-CHG SAINT NAZAIRE
Saint-Nazaire, 44600
Réanimation Chirurgicale-CHRU TOURS
Tours, 37000
Réanimation Médicale-CHRU TOURS
Tours, 37000
About this study
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).
Read more
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.
- Being tested
- maintaining calorie intake, maximum gastric vacuity
- Keywords
- Airway Extubation/adverse effects/ Methods, Nutrition, Ventilator Weaning/methods, Intensive care Unit, Enteral Nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maintaining calorie intakeOther
Maintaining enteral caloric intake at the same rate. No aspiration in the gastric tube.
maximum gastric vacuityOther
stopping enteral feeding at least 6 hours before extubation. Suction in the gastric tube (if its caliber permits) continuously for 6 hours before extubation
| Study group | Role | What they receive |
|---|---|---|
| maximum gastric void | Other | stopping enteral feeding at least 6 hours before extubation. Suction in the gastric tube (if its size permits) continuously for 6 hours before extubation. Receives: Other: maximum gastric vacuity |
| maintaining calorie intake | Other | maintaining enteral caloric intake at the same rate. No aspiration in the gastric tube Receives: Other: maintaining calorie intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
reintubation within 7 days after extubation in intensive care.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start5 Apr 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-inferiority, in Terms of Extubation Failure, Continuation of Enteral Nutrition Before Extubation Versus Gastric Vacuity Peri-extubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335345
- Sponsor's protocol ID
- CHM-2016/S3/07
- Acronym
- AMBROISIE
- Status last verified
- Mar 2022
- First submitted
- 3 Nov 2017
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36693402Landais 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.
PubMed 34016658
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Study of the Pursuit of Enteral Nutrition Compared to a Strategy of Gastric Emptiness Peri-extubation. Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT03335345
- Acronym / sponsor ID
- AMBROISIE / CHM-2016/S3/07
- Keywords
- Airway Extubation/adverse effects/ Methods, Nutrition, Ventilator Weaning/methods, Intensive care Unit, Enteral Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,148 participants (actual)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| maximum gastric void | Other | Other: maximum gastric vacuitystopping enteral feeding at least 6 hours before extubation. Suction in the gastric tube (if its size permits) continuously for 6 hours before extubation. |
| maintaining calorie intake | Other | Other: maintaining calorie intakemaintaining enteral caloric intake at the same rate. No aspiration in the gastric tube |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| maintaining calorie intakeMaintaining enteral caloric intake at the same rate. No aspiration in the gastric tube. | Other | maintaining calorie intake |
| maximum gastric vacuitystopping enteral feeding at least 6 hours before extubation. Suction in the gastric tube (if its caliber permits) continuously for 6 hours before extubation | Other | maximum gastric void |
Primary outcome
reintubation within 7 days after extubation in intensive care.
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Derived from this study: PubMed 36693402Landais 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.
- Derived from this study: PubMed 34016658Landais 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing maintaining calorie intake and maximum gastric vacuity in people with Non-inferiority, in Terms of Extubation Failure, Continuation of Enteral Nutrition Before Extubation Versus Gastric Vacuity Peri-extubation, run by Centre Hospitalier le Mans at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in France, Guadeloupe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reintubation within 7 days after extubation in intensive care. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03335345, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.