Concomitant Bedside Percutaneous Tracheostomy and Ultrasound Gastrostomy

Withdrawn before enrolling · Not applicable

Conditions studied: Gastrostomy, Ventilatory Failure, Respiratory Failure

In brief

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.

Key facts

Study ID

NCT05955534

Run by

University of Maryland, Baltimore

People needed

0

Starts

2024-07-01

Expected to finish

2026-12-01

Last updated by the study team

2024-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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)
• 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.

Where it is running

• University of Maryland Medical Systems — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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