Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05955534
Status:
WITHDRAWN
Last Update Posted:
2024-07-09
First Post:
2023-06-28
Brief Title:
Concomitant Bedside Percutaneous Tracheostomy and Ultrasound Gastrostomy
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Multicenter Randomized Controlled Trial of Concomitant Bedside Percutaneous Tracheostomy and Ultrasound Gastrostomy
Status:
WITHDRAWN
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of supporting resources
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TPUG
Brief 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 patients length of stay in the ICU
Detailed Description:
The research team will assess eligibility during the screening period for percutaneous tracheostomy and gastrostomy Once eligibility is assessed participants andor their legally authorized representative LAR will be approached for consent and enrollment into the trial Randomization occurs at the time of the subjects 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None