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Procedure

Combined Tracheostomy and Gastrostomy for Respiratory Failure (TPUG Trial)

N/A

Waitlist Available

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women of childbearing potential must have negative serum or urine pregnancy test during the current hospitalization

Indication for percutaneous gastrostomy including Percutaneous Ultrasound (PUG), Percutaneous Radiologic (PRG), and Percutaneous Endoscopic Gastrostomy (PEG) using an FDA approved gastrostomy kit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up hospital discharge - through study completion, an average of 45 days

Awards & highlights

TPUG Trial Summary

This trial will assess the safety and efficacy of a procedure that combines feeding and breathing tubes for ICU patients who can't eat or breathe on their own.

Who is the study for?

This trial is for adults in the ICU who need help breathing and eating, have no infections at the procedure site, can consent (or have a representative who can), are not pregnant, and don't have conditions like severe ascites or gastroparesis. It's not for those with non-survivable injuries/diseases or expected to live less than 30 days.Check my eligibility

What is being tested?

The study tests if doing a tracheostomy (breathing tube) and gastrostomy (feeding tube) together improves outcomes. Patients will all get a tracheostomy but will be randomly assigned different FDA-approved methods of gastrostomy to see if this combo reduces ICU stay time.See study design

What are the potential side effects?

Possible side effects include infection risks at the insertion sites, complications from anesthesia during procedures such as apnea or loss of positive pressure ventilation, bleeding due to coagulopathy issues, and potential difficulties related to specific anatomies.

TPUG Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman who can have children and my pregnancy test was negative.

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I need a feeding tube placed using a method approved by the FDA.

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I need a tracheostomy with an FDA-approved device.

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I am 18 years old or older.

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I rely on a ventilator to breathe due to respiratory failure.

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I can safely undergo procedures like tracheostomy or gastrostomy at my bedside.

TPUG Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ hospital discharge - through study completion, an average of 45 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~hospital discharge - through study completion, an average of 45 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and hospital discharge - through study completion, an average of 45 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Length of stay in ICU

Secondary outcome measures

Demographics

Length of hospital stay

TPUG Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intervention Group (TPUG)Experimental Treatment1 Intervention

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

Group II: Control GroupPlacebo Group2 Interventions

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.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor

687 Previous Clinical Trials

374,446 Total Patients Enrolled

Dana Beach, RNStudy ChairUniversity of Maryland, Baltimore

Media Library

TPUG (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05955534 — N/A

Hypoventilation Research Study Groups: Control Group, Intervention Group (TPUG)

Hypoventilation Clinical Trial 2023: TPUG Highlights & Side Effects. Trial Name: NCT05955534 — N/A

TPUG (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05955534 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies available for participants in this examination?

"According to clinicaltrials.gov, this trial has concluded recruitment for participants and is no longer seeking volunteers. The study was initially posted on August 1st 2023 and last updated July 12th of the same year. However 193 other trials are presently accepting new patients into their program."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Concomitant Bedside Percutaneous Tracheostomy and Ultrasound Gastrostomy

Richard Gentry Wilkerson 2024. "Concomitant Bedside Percutaneous Tracheostomy and Ultrasound Gastrostomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05955534.