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Concomitant Bedside Percutaneous Tracheostomy and Ultrasound Gastrostomy (TPUG)

Primary Purpose

Gastrostomy, Ventilatory Failure, Respiratory Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TPUG
PEG
PRG
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrostomy focused on measuring Ventilator Dependent Respiratory Failure, Tracheostomy and Percutaneous Ultrasound Gastrostomy (TPUG), Percutaneous Radiologic Gastrostomy (PRG), PEG, Percutaneous Endoscopic Gastrostomy, Tracheostomy, Gastrostomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 Absolute contraindications to percutaneous dilatational tracheostomy procedure Cervical instability Infection at the planned insertion site Relative contraindications to percutaneous dilatational tracheostomy deemed present by the clinical team Difficult anatomy (e.g., short neck, morbid obesity, minimal next extension, or tracheal deviation) Severe respiratory disease resulting in inability to withstand periods of apnea or in the loss of positive pressure ventilation Pregnancy Incongruent goals of care between care team and LAR (family representative). Other procedure related concerns by the primary team that would affect safety of the patient.

Sites / Locations

  • University of Maryland Medical Systems

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Group

Intervention Group (TPUG)

Arm Description

The control group will receive percutaneous bedside tracheostomy along with gastrostomy methods other than PUG, including but not limited to Percutaneous Endoscopic or Radiologic Gastrostomy (PEG or PRG, respectively), or surgical gastrostomy.

The intervention group will receive concomitant percutaneous bedside tracheostomy and PUG.

Outcomes

Primary Outcome Measures

Length of stay in ICU
To compare the ICU (Intensive Care Unit) length of stay (days) from the time the decision is made to place a tracheostomy tube and gastrostomy tube to the time of discharge from the ICU for participants receiving TPUG versus a control group.

Secondary Outcome Measures

Length of hospital stay
To compare the hospital length of stay (days) and total hospital costs (United States Dollars) from the time the decision is made to place a tracheostomy tube and gastrostomy tube to the time of discharge from the hospital for participants receiving TPUG versus a control group.
Demographics
To assess confounding variables and differences between groups that could affect outcomes: Age (categorized as <50 yrs., 51-70 yrs., >70 yrs) Gender (Assigned at birth) Race (Self-Reported) Insurance (categorized as Insured versus Uninsured) Covid status (categorized as Positive, Negative, Indeterminate) Primary diagnosis Primary ICU type Charlson Score SAPS Score

Full Information

First Posted
June 28, 2023
Last Updated
August 14, 2023
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT05955534
Brief Title
Concomitant Bedside Percutaneous Tracheostomy and Ultrasound Gastrostomy
Acronym
TPUG
Official Title
A Multicenter, Randomized Controlled Trial of Concomitant Bedside Percutaneous Tracheostomy and Ultrasound Gastrostomy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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 patient's 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrostomy, Ventilatory Failure, Respiratory Failure
Keywords
Ventilator Dependent Respiratory Failure, Tracheostomy and Percutaneous Ultrasound Gastrostomy (TPUG), Percutaneous Radiologic Gastrostomy (PRG), PEG, Percutaneous Endoscopic Gastrostomy, Tracheostomy, Gastrostomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All patients enrolled will receive bedside tracheostomy, but each patient will be randomly assigned a common method for gastrostomy placement. Patients in the control group will receive a bedside tracheostomy along with a common method of gastrostomy placement other than PUG, which may be performed at the same time or at a different time in relation to the tracheostomy. Patients in the intervention group will receive a bedside tracheostomy and a PUG at the same time using an FDA-cleared device.
Masking
Investigator
Masking Description
Participants will be randomly assigned to either the intervention group (TPUG) or the control group using a 1:1 randomization scheme.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
The control group will receive percutaneous bedside tracheostomy along with gastrostomy methods other than PUG, including but not limited to Percutaneous Endoscopic or Radiologic Gastrostomy (PEG or PRG, respectively), or surgical gastrostomy.
Arm Title
Intervention Group (TPUG)
Arm Type
Experimental
Arm Description
The intervention group will receive concomitant percutaneous bedside tracheostomy and PUG.
Intervention Type
Device
Intervention Name(s)
TPUG
Other Intervention Name(s)
Percutaneous Tracheostomy and Percutaneous Ultrasound Gastrostomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
PEG
Other Intervention Name(s)
Percutaneous Endoscopic Gastrostomy
Intervention Description
Each site will perform the procedures of gastrostomy placement using the devices according to their institutional policy and guidelines.
Intervention Type
Procedure
Intervention Name(s)
PRG
Other Intervention Name(s)
Percutaneous Radiographic Gastrostomy
Intervention Description
Each site will perform the procedures of gastrostomy placement using the devices according to their institutional policy and guidelines.
Primary Outcome Measure Information:
Title
Length of stay in ICU
Description
To compare the ICU (Intensive Care Unit) length of stay (days) from the time the decision is made to place a tracheostomy tube and gastrostomy tube to the time of discharge from the ICU for participants receiving TPUG versus a control group.
Time Frame
ICU discharge - up to 24 weeks
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
To compare the hospital length of stay (days) and total hospital costs (United States Dollars) from the time the decision is made to place a tracheostomy tube and gastrostomy tube to the time of discharge from the hospital for participants receiving TPUG versus a control group.
Time Frame
Hospital discharge - through study completion, an average of 45 days
Title
Demographics
Description
To assess confounding variables and differences between groups that could affect outcomes: Age (categorized as <50 yrs., 51-70 yrs., >70 yrs) Gender (Assigned at birth) Race (Self-Reported) Insurance (categorized as Insured versus Uninsured) Covid status (categorized as Positive, Negative, Indeterminate) Primary diagnosis Primary ICU type Charlson Score SAPS Score
Time Frame
End of study comparison - through study completion, an average of 45 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 Absolute contraindications to percutaneous dilatational tracheostomy procedure Cervical instability Infection at the planned insertion site Relative contraindications to percutaneous dilatational tracheostomy deemed present by the clinical team Difficult anatomy (e.g., short neck, morbid obesity, minimal next extension, or tracheal deviation) Severe respiratory disease resulting in inability to withstand periods of apnea or in the loss of positive pressure ventilation Pregnancy Incongruent goals of care between care team and LAR (family representative). Other procedure related concerns by the primary team that would affect safety of the patient.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Gentry Wilkerson, M.D.
Phone
410-328-4237
Email
gwilkerson@som.umaryland.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana Beach, RN
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Study Chair
Facility Information:
Facility Name
University of Maryland Medical Systems
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Principal Investigator will centrally aggregate and maintain screening and recruitment information from all study sites and routinely inform and share this data with the entire study team in a deidentified fashion. The principal investigator and co-investigators will maintain a personal participant identification list (participant numbers with the corresponding participant names) to enable records to be identified. The University of Maryland School of Medicine's research team will ensure that all study-related documents are collected and maintained.
IPD Sharing Time Frame
Until the end of the study. Essential documents will be retained for at least 2 years.
IPD Sharing Access Criteria
All study team members will attend online trainings to receive instruction on the protocol, consent process and associated regulatory requirements for the conduct of Clinical Trials/Human Subjects Research. All persons assisting with the trial are adequately informed about the protocol, any amendments to the protocol, any changes to the informed consent form, the trial treatments, eligibility criteria and their trial related duties and functions.

Learn more about this trial

Concomitant Bedside Percutaneous Tracheostomy and Ultrasound Gastrostomy

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