Concomitant Bedside Percutaneous Tracheostomy and Ultrasound Gastrostomy

Respiratory Failure Clinical Trial

— TPUG  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05955534
• Other study ID #: HP-00104764
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: December 1, 2026

Study information

• Verified date: March 2024
• Source: University of Maryland, Baltimore
• Contact: Richard Gentry Wilkerson, M.D.
• Phone: 410-328-4237
• Email: gwilkerson[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastrostomy
• Hypoventilation
• Respiratory Failure
• Respiratory Insufficiency
• Ventilatory Failure

Intervention

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.

Procedure:
• PEG
Each site will perform the procedures of gastrostomy placement using the devices according to their institutional policy and guidelines.
• PRG
Each site will perform the procedures of gastrostomy placement using the devices according to their institutional policy and guidelines.

Locations

Country	Name	City	State
United States	University of Maryland Medical Systems	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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