Concomitant Bedside Percutaneous Tracheostomy and Ultrasound Gastrostomy

NCT ID: NCT05955534

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2026-12-01

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

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.

Group Type: PLACEBO_COMPARATOR

PEG

Intervention Type: PROCEDURE

Each site will perform the procedures of gastrostomy placement using the devices according to their institutional policy and guidelines.

PRG

Intervention Type: PROCEDURE

Each site will perform the procedures of gastrostomy placement using the devices according to their institutional policy and guidelines.

Intervention Group (TPUG)

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

Group Type: EXPERIMENTAL

TPUG

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

PEG

Each site will perform the procedures of gastrostomy placement using the devices according to their institutional policy and guidelines.

Intervention Type: PROCEDURE

PRG

Each site will perform the procedures of gastrostomy placement using the devices according to their institutional policy and guidelines.

Intervention Type: PROCEDURE

Other Intervention Names

Percutaneous Tracheostomy and Percutaneous Ultrasound Gastrostomy; Percutaneous Endoscopic Gastrostomy; Percutaneous Radiographic Gastrostomy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Richard Gentry Wilkerson

Associate Professor, Director of Clinical Research, Assistant Residency Program Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dana Beach, RN

Role: STUDY_CHAIR

University of Maryland, Baltimore

Locations

University of Maryland Medical Systems

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

HP-00104764

Identifier Type: -

Identifier Source: org_study_id