Concomitant Bedside Percutaneous Tracheostomy & Ultrasound Gastrostomy

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

The research team will assess eligibility during the screening period for percutaneous tracheostomy and gastrostomy. Once eligibility is assessed, participants and/or their legally authorized representative (LAR) will be approached for consent and enrollment into the trial. Randomization occurs at the time of the subject's enrollment, and participants will be randomized to either the Control or Intervention (TPUG) groups using randomly assigned numbers. The study team will also be blinded to the assigned group prior to recruitment to limit selection bias. The intervention group will receive concomitant placement of the tracheostomy and PUG, which will be performed using the FDA-cleared device for ultrasound gastrostomy, the PUMA-G System. The control group will receive percutaneous bedside tracheostomy along with gastrostomy methods other than PUG. Each site will perform the procedures of tracheostomy and gastrostomy using the devices according to their institutional policy and guidelines. Investigators will utilize case report forms (CRFs) and chart review to collect demographic information, important medical events, illnesses, and laboratory data needed for outcomes assessment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05955534
Study type	Interventional
Source	University of Maryland, Baltimore
Contact	Richard Gentry Wilkerson, M.D.
Phone	410-328-4237
Email	gwilkerson@som.umaryland.edu
Status	Not yet recruiting
Phase	N/A
Start date	May 2024
Completion date	December 1, 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Concomitant Bedside Percutaneous Tracheostomy and Ultrasound Gastrostomy — TPUG

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms