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New treatment option for Critical Illness
Official title Preoperative Fasting vs. Not Fasting in Critically Ill Patients
ClinicalTrials.gov ID: NCT06751043
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Planned eligible procedure (Examples are listed in Appendix C) with anesthesia care or nursing sedation. Eligible procedures are defined as...
You likely can't join if
- 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
- Critically ill burn patient
- Emergency procedure
See the full eligibility criteria
- 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
- Planned eligible procedure (Examples are listed in Appendix C) with anesthesia care or nursing sedation. Eligible procedures are defined as non-emergent diagnostic or therapeutic interventions that:
- Do NOT have a well-established practice of preoperative fasting. (For example, bedside placement of a vascular catheter [arterial, central venous, peripheral venous] by the ICU team is NOT eligible for this trial since...
- Do NOT require fasting for preoperative gastrointestinal tract preparation
- Do NOT require removal/replacement of the endotracheal or tracheostomy tube
- Do NOT require prone or Trendelenburg (head-down) positioning.
- Typically require procedural sedation or anesthesia care.
- Generally, are scheduled for a specific time (although this time can change, or procedure may be cancelled).
- Are performed in the operating room, non-operating room procedural areas, or at the patient's bedside.
- All ICU types are eligible: surgical, medical, cardiac, neurological, trauma, mixed etc.
- Secure airway is defined as a cuffed endotracheal tube or a cuffed tracheostomy tube.
- Patients with all types of feeding tubes are eligible, regardless of tube insertion site (nasal, oral, surgically implanted) and tube tip location (pre- and post-pyloric) †As determined by the enrolling...
- 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
- Critically ill burn patient
- Emergency procedure
- a. Gastrointestinal tract procedure that requires fasting based on surgical indications or b. airway/lung procedure that requires removal of endotracheal or tracheostomy tube
- Plan for prone or Trendelenburg (head down) positioning during most of the procedure
- Major impairment of gastrointestinal motility or major structural disease of the gastrointestinal tract (e.g., severe gastroparesis, bowel obstruction, severe ileus, severely compromised lower esophageal sphincter...
- Plan for postoperative extubation in the procedure area
- Prisoner
- Pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test during the current hospitalization, or woman who is breast feeding
- Refusal to enroll patient by treating physician
- Extracorporeal Membrane Oxygenation (ECMO) at the time of potential enrollment, except patients scheduled for ECMO decannulation as the study procedure and patients expected to be off of ECMO at the time of study...
- Chronic mechanical ventilation at pre-admission level of care
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Worcester, Massachusetts, United States
- Minneapolis, Minnesota, United States
- New York, New York, United States
- Rochester, New York, United States
- The Bronx, New York, United States
- Winston-Salem, North Carolina, United States
- Cleveland, Ohio, United States
- Galveston, Texas, United States
- Houston, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; San Francisco, California, United States; Aurora, Colorado, United States; Miami, Florida, United States; Chicago, Illinois, United States; Baltimore, Maryland, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.