About this trial
The goal of this clinical trial is to learn if fasting or not fasting before a procedure has an effect on recovery in those who are critically ill. The main questions it aims to answer for patients on a breathing machine who are receiving tube feeding are:
* Does the risk of lung complications and death differ between those who are not fasting, which may have a higher chance of allowing tube feeding to enter the lungs, and fasting, which temporarily stops nutrition before a procedure? * Is there a difference in recovery times, hospital stays, infection rates, need for organ support, safety, and nutrition for those who either fast or do not fast before a procedure? * What is the relationship between nutrition and clinical outcomes?
Researchers will compare not fasting and fasting to see if it has an effect on recovery.
Participants will:
* Be assigned by chance (like a coin toss) to one of two groups. One group (fasting group) will have their tube feeding stopped at least 8 hours before their procedure. The other group (not fasting group) will have their tube feeding stopped right before their procedure. * Be monitored via medical record for amount of protein and calories received, and any complications related to fasting/not fasting.
* Data from routine electronic medical records will be reviewed to determine how participants are doing 3 months after their procedure.
'
Eligibility criteria
Qualifiers
1. Age ≥ 18
Current admission to ICU*
Secure airway** with no plans for its removal prior to procedure
Current non-trophic (> 10 mL/hr) tube (enteral) feeding*** with no plans to discontinue prior to procedure for reasons other than preoperative fasting
Disqualifiers
Inability to obtain informed consent
Inability to enroll and randomize > 8 hours prior to planned procedure time
Inability to deliver trial interventions
Expected survival < 48 hours as determined by the enrolling physician-investigator
Trial design
Treatments tested in this trial
- Fasting
- Not fasting
Treatment groups
Sponsors and collaborators
Massachusetts General Hospital
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Columbia University
Collaborator