WithdrawnNot Applicable

Concomitant Bedside Percutaneous Tracheostomy and Ultrasound Gastrostomy

Stopped: Lack of supporting resources

United States0Started 2024-07

Plain-language summary

The goal of this research study is to assess the FDA approved technique for inserting a feeding tube (gastrostomy) along with a breathing tube (tracheostomy) for patients that cannot breathe or eat on their own in the ICU (Intensive Care Unit). All subjects in the study will receive a tracheostomy, but each patient will be randomly assigned a common method for gastrostomy placement. The placement of the tube and tracheostomy will occur as part of normal clinical practice. Researchers will compare subjects in the control group and the intervention group to evaluate the benefits of performing a tracheostomy and gastrostomy tube at the same time. Researchers will also evaluate the likelihood of the PUG procedure decreasing a patient's length of stay in the ICU.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Informed consent must be obtained from the participant or a Legally Authorized Representative before any trial-specific assessment is performed * Male or female ≥ 18 years of age * Participants with Ventilator Dependent Respiratory Failure (VDRF) * Indication for a bedside percutaneous tracheostomy procedure using an FDA approved percutaneous dilatational tracheostomy device * Indication for percutaneous gastrostomy including Percutaneous Ultrasound (PUG), Percutaneous Radiologic (PRG), and Percutaneous Endoscopic Gastrostomy (PEG) using an FDA approved gastrostomy kit * No contraindications to bedside percutaneous tracheostomy OR gastrostomy * Women of childbearing potential must have negative serum or urine pregnancy test during the current hospitalization Exclusion Criteria: * History of prior gastrostomy, tracheostomy, laryngectomy, gastrostomy prior to tracheostomy decision, known head and neck and gastrointestinal abnormality (cancer, congenital abnormality, anatomic variants). * Hospitalization \> 21 days at the time of screening * Known social discharge issues that in the opinion of the investigator will substantially impact the LOS. * Participants with non-survivable injuries or disease, anticipated life expectancy \< 30 days. * Uncontrolled coagulopathy * Contraindications for percutaneous gastrostomy procedures * Severe Ascites * Abdominal wall infection at selected site of procedure * Severe gastroparesis * Gastric outlet obstruction * Abs…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Length of stay in ICU

Timeframe: ICU discharge - up to 24 weeks

Trial details

NCT IDNCT05955534

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01

View on ClinicalTrials.gov More Gastrostomy trials