Concomitant Bedside Percutaneous Tracheostomy and Ultrasound Gastrostomy

NCT05955534 | Withdrawn FDA Device

• 1 other identifier: HP-00104764
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Length of hospital stay

  Hospital discharge - through study completion, an average of 45 days

• Demographics

  End of study comparison - through study completion, an average of 45 days

Study Arms (2)

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.

Procedure: PEG; Procedure: PRG

Intervention Group (TPUG)

EXPERIMENTAL

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

Device: TPUG

Interventions

TPUG 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.

Also known as: Percutaneous Tracheostomy and Percutaneous Ultrasound Gastrostomy

Intervention Group (TPUG)

PEG PROCEDURE

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

Control Group

PRG PROCEDURE

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

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Systems

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Hypoventilation; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dana Beach, RN

  University of Maryland, Baltimore

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Participants will be randomly assigned to either the intervention group (TPUG) or the control group using a 1:1 randomization scheme.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Director of Clinical Research, Assistant Residency Program Director

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 21, 2023
• Study Start: July 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• 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.

Locations

US (1)