Portal de Periódicos da CAPES

Feasibility Assessment of Computer-Assisted Personalized Sedation

2006; Lippincott Williams & Wilkins; Volume: 101; Linguagem: Inglês

10.14309/00000434-200609001-01325

1572-0241

Daniel J. Pambianco, Christopher J. Whitten, Anneliese Moerman, Michel Struys, James G. Martin, Johnson W. McRorie,

Healthcare Technology and Patient Monitoring

Purpose: Computer-Assisted Personalized Sedation (CAPS) is a novel method integrating continuous physiological monitoring and delivery of propofol through a computer interface to provide precise control of sedation. These studies were designed to assess the feasibility of an investigational CAPS device to facilitate propofol sedation by a gastroenterologist/nurse team. Methods: In two IRB/EC approved studies, 48 subjects (12 colonoscopy and 12 EGD; in both US and Belgium) were sedated with the device by the gastroenterologist/nurse teams. Results: Forty-eight subjects (13 ASA I; 24 II; 11 III) completed the studies. Subjects received a single fentanyl dose (mean 88.5 ± 23.3 mcg in the US and 67.1 ± 30.5 mcg in Belgium). Three minutes later propofol was initiated at 75 mcg/kg/minute, then titrated to desired clinical effect (mean total dose 65.4 ± 24.7 mg in the US and 72.1 ± 36.6 mg in Belgium). Subjects were calm, comfortable and cooperative at a mean MOAA/S score of 4.4 ± 1.0 in the US and 4.4 ± 0.8 in Belgium. For colonoscopy, 17% of US and 33% of Belgian subjects had polyps removed. Procedure times (scope-in to scope-out) for colonoscopy were 9.5 ± 2.1 min in the US and 11.9 ± 3.9 min in Belgium. For EGD, procedure times were 2.5 ± 0.7 min in the US and 2.7 ± 1.0 min in Belgium. Recovery times (scope-out to Aldrete ≥ 12) for colonoscopy were 29 ± 37 seconds in the US and 10 ± 6 seconds in Belgium. Recovery times for EGD were 28 ± 30 seconds in the US and 10 ± 5 seconds in Belgium. Two US subjects and one Belgian subject experienced a total of 5 oxygen desaturation events below 90% (low 78% US, 84% Belgium). Twelve US subjects and six Belgian subjects experienced apnea ≥ 30 seconds (total of 40 events). Automated device actions in response to apnea resulted in recovery of normal respiratory parameters within a mean of 6 seconds. Validated physician and patient satisfaction with sedation scores showed high satisfaction with this new sedation paradigm. Conclusions: These studies demonstrated the feasibility of CAPS to facilitate propofol sedation by gastroenterologist/nurse teams to subjects undergoing GI endoscopy.