2005 OPEN FORUM Abstracts
DISSECTION OF THE BARD RESPISHIELD with InnoValve CLOSED SUCTION SYSTEM CATHETER, A CASE STUDY
Tim Frymyer, BS, RRT, Anne Schaer, RRT, David Mussetter, BA, RRT, Michael Trevino, MS, RRT, Gary Weinstein, MD, FCCP, Presbyterian Hospital of Dallas, Dallas, Texas.
INTRODUCTION: The in-line closed suction catheter is a common element in today's ventilator circuit. We currently employ the Kimberly-Clarkä/Ballardä Adult Trach Careä in-line suction catheter in all of our ventilator circuit set-ups, along with the GibeckÒ Humid VentÒ Filter Light (VT 250 - 1500 ml) HME. Ballard has enjoyed a large market share in this niche medical device area and has been a part of the standard of care in our hospital over the last 15 years. In March 2005, we were presented the opportunity to evaluate the BARD RespiShield with InnoValve closed suction system.
CASE SUMMARY: We began our product trial on March 28th, 2005. No hazards or complications to patient care had been observed. We placed the product in three ICUs and used 42 RespiShield endotracheal starter kits and 12 replacement kits over the course of the trial. On April 12th, an 85 year-old female experienced respiratory failure due to retained secretions. The family had decided that intubation and bronchoscopy in this case was warranted as her failure was deemed a reversible process (the retained secretions). The RespiShield closed suction system was placed between the patient's endotracheal tube (ETT) and the Gibeck HME after the bronchoscopy. The suction catheter was then used on a routine basis by the nursing and respiratory therapy staff throughout that evening, night and early next morning. One of our respiratory therapy product investigators, evaluated the patient the next morning, 18 hours post intubation. She opened the InnoValve and began to suction the patient's ETT. She quickly noticed the catheter would not advance into the patient's ETT. After closing the InnoValve, the closed in-line catheter was removed for direct visualization. Upon closer examination, the beveled tip of the catheter was missing, apparently sheared away. She looked for the minuscule fragment, but it could not be recovered. The RespiShield catheters were then removed and the product evaluation terminated. The attending MD was notified of the potential for a retained item in this patient. The patient did not exhibit any response or adverse reaction. The patient's chest x-ray did not reveal evidence that the minute fragment was present. The patient's course then progressed normally for someone with her condition and debilitation. She was extubated without incident 96 hours post-intubation. At 72 hours post-extubation, she was receiving volume expansion therapy and supplemental oxygen at 2 lpm with a SpO2 of 96%. Patient did not have any new findings on chest x-ray.
DISCUSSION: Prior to the evaluation, we were concerned that closing the InnoValve could potentially dissect the catheter if left in the InnoValve housing. We attempted to create this circumstance before the trial and were only able to accomplish this by exerting tremendous effort and torque, none of which would be present in the clinical environment. However, in this case study, the tearing of the catheter occurred below the eyelets on the beveled tip. This event was then duplicated in a bench model by inserting the beveled catheter tip into the housing and then closing the InnoValve. The InnoValve had only one side of the catheter to cut through, which dramatically reduced the effort or torque required. The bench results showed the same shearing pattern on the end of the catheter that was present on the in vivo catheter. As a result of this experience, BARD reports to us they have made changes to their catheter design.