Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335345
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : March 10, 2022
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier le Mans

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Non-inferiority, in Terms of Extubation Failure, Continuation of Enteral Nutrition Before Extubation Versus Gastric Vacuity Peri-extubation Other: maintaining calorie intake Other: maximum gastric vacuity Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Non-inferiority Study of the Pursuit of Enteral Nutrition Compared to a Strategy of Gastric Emptiness Peri-extubation. Cluster Randomized Trial
Actual Study Start Date : April 5, 2018
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 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
maintaining calorie intake
maintaining enteral caloric intake at the same rate. No aspiration in the gastric tube
 Other: maintaining calorie intake
Maintaining enteral caloric intake at the same rate. No aspiration in the gastric tube.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. reintubation within 7 days after extubation in intensive care. [ Time Frame: 7 days ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335345


Locations
Show Show 22 study locations
Sponsors and Collaborators
Centre Hospitalier le Mans
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Centre Hospitalier le Mans
ClinicalTrials.gov Identifier: NCT03335345    
Other Study ID Numbers: CHM-2016/S3/07
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: March 10, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier le Mans:
Airway Extubation/adverse effects/ Methods
Nutrition
Ventilator Weaning/methods
Intensive care Unit
Enteral Nutrition