An interventional study of TPUG and PEG in Gastrostomy, Ventilatory Failure and Respiratory Failure, sponsored by University of Maryland, Baltimore. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-09.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Treatment
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.
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.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: PEG · Procedure: PRG
The intervention group will receive concomitant percutaneous bedside tracheostomy and PUG.
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.
Also known as: Percutaneous Tracheostomy and Percutaneous Ultrasound Gastrostomy
Each site will perform the procedures of gastrostomy placement using the devices according to their institutional policy and guidelines.
Also known as: Percutaneous Endoscopic Gastrostomy
Each site will perform the procedures of gastrostomy placement using the devices according to their institutional policy and guidelines.
Also known as: Percutaneous Radiographic Gastrostomy
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.
Time frame: ICU discharge - up to 24 weeks
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.
Time frame: Hospital discharge - through study completion, an average of 45 days
Demographics
To assess confounding variables and differences between groups that could affect outcomes: 1. Age (categorized as \<50 yrs., 51-70 yrs., \>70 yrs) 2. Gender (Assigned at birth) 3. Race (Self-Reported) 4. Insurance (categorized as Insured versus Uninsured) 5. Covid status (categorized as Positive, Negative, Indeterminate) 6. Primary diagnosis 7. Primary ICU type 8. Charlson Score 9. SAPS Score
Time frame: End of study comparison - through study completion, an average of 45 days
Plan to share: 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.
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: Until the end of the study. Essential documents will be retained for at least 2 years.
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.
No publications or documents are linked to this record.
Start is estimated for Jul 2024; primary completion for Dec 2025, 17 months later.
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This study is withdrawn, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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