GastrostomyTPUGNCT05955534
Concomitant Bedside Percutaneous Tracheostomy and Ultrasound Gastrostomy
A study testing TPUG, PEG and PRG in people with Gastrostomy and Ventilatory Failure, run by University of Maryland, Baltimore at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastrostomy, Ventilatory Failure, Respiratory Failure
- What is being tested?
- TPUG, PEG and PRG
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Systems
Baltimore, Maryland, 21201
About this study
Official title: A Multicenter, Randomized Controlled Trial of Concomitant Bedside Percutaneous Tracheostomy and Ultrasound Gastrostomy
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.
Read the 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.
- Conditions
- Gastrostomy, Ventilatory Failure, Respiratory Failure
- Being tested
- TPUG, PEG, PRG
- Keywords
- Ventilator Dependent Respiratory Failure, Tracheostomy and Percutaneous Ultrasound Gastrostomy (TPUG), Percutaneous Radiologic Gastrostomy (PRG), PEG, Percutaneous Endoscopic Gastrostomy, Tracheostomy, Gastrostomy
- Medical subject headings
- Hypoventilation, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPUGDevice
Also called Percutaneous Tracheostomy and Percutaneous Ultrasound Gastrostomy
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.
PEGProcedure or surgery
Also called Percutaneous Endoscopic Gastrostomy
Each site will perform the procedures of gastrostomy placement using the devices according to their institutional policy and guidelines.
PRGProcedure or surgery
Also called Percutaneous Radiographic Gastrostomy
Each site will perform the procedures of gastrostomy placement using the devices according to their institutional policy and guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | 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. Receives: Procedure: PEG; Procedure: PRG |
| Intervention Group (TPUG) | Experimental | The intervention group will receive concomitant percutaneous bedside tracheostomy and PUG. Receives: Device: TPUG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ICU discharge - up to 24 weeks
Secondary outcomes (2)
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.
Measured: Hospital discharge - through study completion, an average of 45 days
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
Measured: End of study comparison - through study completion, an average of 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study startJul 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Why it stopped: Lack of supporting resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastrostomyStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Gentry Wilkerson, University of Maryland, Baltimore
- Investigators
- Dana Beach, RN, Study chair, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955534
- Sponsor's protocol ID
- HP-00104764
- Acronym
- TPUG
- Status last verified
- Jul 2024
- First submitted
- 28 Jun 2023
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled Trial of Concomitant Bedside Percutaneous Tracheostomy and Ultrasound Gastrostomy
- ClinicalTrials.gov ID
- NCT05955534
- Acronym / sponsor ID
- TPUG / HP-00104764
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of supporting resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Procedure: PEG, Procedure: PRGThe 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. |
| Intervention Group (TPUG) | Experimental | Device: TPUGThe intervention group will receive concomitant percutaneous bedside tracheostomy and PUG. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TPUGAlso: Percutaneous Tracheostomy and Percutaneous Ultrasound GastrostomyTracheostomy 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. | Device | Intervention Group (TPUG) |
| PEGAlso: Percutaneous Endoscopic GastrostomyEach site will perform the procedures of gastrostomy placement using the devices according to their institutional policy and guidelines. | Procedure or surgery | Control Group |
| PRGAlso: Percutaneous Radiographic GastrostomyEach site will perform the procedures of gastrostomy placement using the devices according to their institutional policy and guidelines. | Procedure or surgery | Control Group |
Primary outcome
Length of stay in ICU
Time frame: ICU discharge - up to 24 weeks
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.
2 secondary outcomes
Length of hospital stay
Time frame: Hospital discharge - through study completion, an average of 45 days
Demographics
Time frame: End of study comparison - through study completion, an average of 45 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana Beach, RN study chair
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TPUG, PEG and PRG in people with Gastrostomy and Ventilatory Failure, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay in ICU (time frame: ICU discharge - up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.