Percutaneous ultrasound gastrostomy (PUG): first prospective clinical trial

Abstract

Graphical abstarct Purpose To report the results of the first-in-human trial evaluating the safety and efficacy of the percutaneous ultrasound gastrostomy (PUG) technique. Methods A prospective, industry-sponsored single-arm clinical trial of PUG insertion was performed in 25 adult patients under investigational device exemption (mean age 64 ± 15 years, 92% men, 80% inpatients, mean BMI 24.5 ± 2.7 kg/m2). A propensity score-matched retrospective cohort of 25 patients who received percutaneous radiologic gastrostomy (PRG) was generated as an institutional control (mean age 66 ± 14 years, 92% men, 80% inpatients, mean BMI 24.0 ± 2.7 kg/m2). Primary outcomes included successful insertion and 30-day procedure-related adverse events (AE’s). Secondary outcomes included procedural duration, sedation requirements, and hospital length of stay. Results All PUG procedures were successful, including 3/25 [12%] performed bedside within the ICU. There was no significant difference between PUG and PRG in rates of mild AE’s (3/25 [12%] for PUG and 7/25 [28%] for PRG, p = 0.16) or moderate AE’s (1/25 [4%] for PUG and 0/25 for PRG, p = 0.31). There were no severe AE’s or 30-day procedure-related mortality in either group. Procedural room time was longer for PUG (56.5 ± 14.1 min) than PRG (39.3 ± 15.0 min, p < 0.001). PUG procedure time was significantly shorter after a procedural enhancement, the incorporation of a Gauss meter to facilitate successful magnetic gastropexy. Length of stay for outpatients did not significantly differ (2.4 ± 0.5 days for PUG and 2.6 ± 1.0 days for PRG, p = 0.70). Conclusion PUG appears effective with a safety profile similar to PRG. Bedside point-of-care gastrostomy tube insertion using the PUG technique shows promise. Trial Registration Number: ClinicalTrials.gov ID NCT03575754. Graphical abstract

Length of Stay and Hospital Cost Reductions After Implementing Bedside Percutaneous Ultrasound Gastrostomy (PUG) in a Critical Care Unit

“…Methods for performing PUG have been previously described by this group as well as others. 4,[13][14][15][16] Critical care physicians not trained in PUG relied on usual care gastrostomy placement processes (i.e. consultation and placement by gastroenterology or interventional radiology services in the operating suite).…”

“…Percutaneous ultrasound gastrostomy (PUG) is a broadly accessible bedside gastrostomy procedure shown to be safe and effective, using point-of-care ultrasound rather than endoscopy. 4,[12][13][14][15] Utilizing a magnetic gastropexy, PUG enables real time ultrasound visualization of the access needle and surrounding viscera during gastrostomy tract formation, similar to ultrasound visualization in central line placement. Due to the magnetic gastropexy, PUG is contraindicated in patients with implanted electronically active medical devices, however, PUG otherwise shares similar indications and contraindications as other percutaneous gastrostomy methods.…”

Updates in percutaneous tracheostomy and gastrostomy: should we strive for combined placement during one procedure?

“…More importantly, PUG may expand the ability for gastrostomy placement to intensivists, who may have barriers to credentialing for endoscopic procedures such as PEG. The feasibility of PUG has been shown in several studies by interventional radiologists and critical care physicians [49 ▪ ,50].…”