Is NCT06751043 recruiting in Boston, MA?

Yes, NCT06751043 is currently recruiting participants at its Boston, MA location. This critical illness clinical trial is actively enrolling qualified participants.

How do I join the critical illness clinical trial in Boston?

To join this clinical trial in Boston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Boston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Critical Illness Clinical Trial in Boston, MA

About This Critical Illness Study in Boston

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. '

Sponsor: Massachusetts General Hospital

Who Can Participate

Inclusion 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 it has a widely established practice of no preoperative fasting and is not generally scheduled for a specific time.)

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 physician-investigator

Exclusion Criteria

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, active gastrointestinal bleeding)

Plan for postoperative extubation in the procedure area

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 procedure.

Chronic mechanical ventilation at pre-admission level of care

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT06751043) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Critical Illness Treatment Options in Boston, MA

If you're searching for critical illness treatment options in Boston, MA, this clinical trial (NCT06751043) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced critical illness specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all critical illness clinical trials near you to find additional studies recruiting in your area.

Critical Illness Clinical Trial in Boston, MA

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