Concomitant Bedside Percutaneous Tracheostomy and Ultrasound Gastrostomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicenter, Randomized Controlled Trial of Concomitant Bedside Percutaneous Tracheostomy and Ultrasound Gastrostomy

Conditions
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Gastrostomy, Ventilatory Failure, Respiratory Failure

Intervention / Treatment
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* Device: TPUG
* Procedure: PEG
* Procedure: PRG


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>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<br>* Each site will perform the procedures of gastrostomy placement using the devices according to their institutional policy and guidelines.<br>* Other names: Percutaneous Endoscopic Gastrostomy;Procedure: PRG<br>* Each site will perform the procedures of gastrostomy placement using the devices according to their institutional policy and guidelines.<br>* Other names: Percutaneous Radiographic Gastrostomy;|
| Experimental: Intervention Group (TPUG)<br>The intervention group will receive concomitant percutaneous bedside tracheostomy and PUG. | Device: TPUG<br>* 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.<br>* Other names: Percutaneous Tracheostomy and Percutaneous Ultrasound Gastrostomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | ICU discharge - up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | End of study comparison - through study completion, an average of 45 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventilator Dependent Respiratory Failure, Tracheostomy and Percutaneous Ultrasound Gastrostomy (TPUG), Percutaneous Radiologic Gastrostomy (PRG), PEG, Percutaneous Endoscopic Gastrostomy, Tracheostomy, Gastrostomy