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Concomitant Bedside Percutaneous Tracheostomy and Ultrasound Gastrostomy

NCT05955534 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-07-09

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

TPUG

Tracheostomy shall utilize any FDA approved device for the performance of percutaneous dilatational tracheostomy. PUG shall be performed using the only FDA-cleared device for ultrasound gastrostomy, the PUMA-G System.

PROCEDURE

PEG

Each site will perform the procedures of gastrostomy placement using the devices according to their institutional policy and guidelines.

PROCEDURE

PRG

Each site will perform the procedures of gastrostomy placement using the devices according to their institutional policy and guidelines.

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Dana Beach, RN · University of Maryland, Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2025-12-01
Completion
2026-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05955534 on ClinicalTrials.gov