CAPS Device for Propofol Sedation Demonstrates Nurse Confidence and Ease of Use

BALTIMORE – A computer-assisted personalized sedation (CAPS) device is being tested to determine whether it could provide physician/nurse team with an on-label means of confidently administering propofol sedation for routine esophagogastroduodenoscopy (EGD) and colonoscopy procedures. The feasibility study, completed last year, was presented at the Society of Gastroenterology Nurses and Associates (SGNA) Annual Meeting by Claudia Wisman, RN, CRC, in a presentation entitled, "Computer-Assisted Personalized Sedation (CAPS) for GI Endoscopy: Nursing Implications and Patient Satisfaction." The SGNA meeting was held in Baltimore from May 19-24.

Results of the feasibility study demonstrated the ability of the device to facilitate the administration of minimal to moderate propofol sedation appropriate to individual patient needs, while achieving high clinician and patient satisfaction, and rapid recovery times. None of the patients required the assistance of manual or mechanical ventilation during the procedures, and no device-related adverse events were reported. The U.S. study included 24 subjects undergoing elective endoscopy (12 colonoscopy and 12 EGD).

As the assistant to the endoscopist in the feasibility study, the nurse was comfortable using the device to administer propofol sedation and assess subjects. Overall, the nurse found the investigational CAPS device intuitive and user-friendly, leading to a short learning curve. The dosing limits and the automated response algorithms built into this CAPS device gave the team confidence that the system could be used to maintain an appropriate level of sedation for each patient throughout the procedure.i Subjects were calm, comfortable and cooperative; all procedures were successfully completed; and recovery occurred on average in 29 seconds.

"Endoscopy and colonoscopy are common procedures, yet often unnecessarily feared by patients. Anything that can improve the patient experience is welcome," said Wisman. "Patients could benefit from the tight control of sedation, quick recovery and few side effects that the computer-assisted personalized sedation technology may be able to offer, once confirmed by larger clinical studies."

Ethicon Endo-Surgery’s device is the first in the category of computer-assisted personalized sedation that utilizes computerization to increase the predictability and reliability of sedation delivery. It combines continuous physiological monitoring and the delivery of propofol through a computer interface to facilitate precise and personalized sedation. The system is designed for use by a physician/nurse team for routine EGD and colonoscopy procedures.

The investigational system continually monitors and records seven patient parameters including oxygen saturation, respiratory rate, heart rate, blood pressure, end-tidal carbon dioxide, patient responsiveness and ECG. It delivers oxygen and automatically reacts to signs of over-sedation (oxygen desaturation and low respiratory rate/apnea) by stopping or reducing propofol delivery, increasing oxygen delivery and automatically instructing patients to take a deep breath. The system is an investigational product limited by U.S. law to investigational use only.

"We recognize that many nurses are concerned about the risks associated with propofol delivery today," said Michael Gustafson, executive director, Ethicon Endo-Surgery. "By developing a device that has the potential to safeguard against over-sedation with propofol and is easy to use by nurses, we are encouraged that we can successfully address nurse concerns."

Propofol (also known as DIPRIVAN®) is considered a preferred sedative due to its rapid onset, and quick, clear-headed recovery. Propofol labeling includes a warning stating that the drug should be administered only by persons trained in the administration of general anesthesia. However, today it is impractical for anesthesia professionals to be present for all endoscopy procedures requiring sedation. Pending favorable results from the pivotal trial, this CAPS device can be approved with labeling that enables physician/nurse teams to administer propofol during routine EGD and colonoscopy procedures.

The pivotal trial to gain marketing approval from the FDA recently commenced and is expected to be completed by the fourth quarter of 2007. Ethicon Endo-Surgery intends to submit the pivotal results to the FDA in a premarket approval (PMA) submission.

Source: Ethicon Endo-Surgery

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