Utility of the Smart Pilot View in Clinical Practice: A Two Center Prospective Observational Study

Completed

• Conditions: Anesthesia,General

• Registration Number: NCT01467167
• Lead Sponsor: University Medical Center Groningen

Brief Summary

Recently, a new software program for anesthesia has been developed, called Smart Pilot View. This program monitors the patient, the anesthetic drugs given, and the calculated depth of the anesthesia. The purpose of this study is to determine whether the use of this program improves the quality of anesthesia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-14
• Study Start: 2011-10
• Study First Submitted QC: 2011-11-03
• Study First Posted: 2011-11-08
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Elective surgery
• General anesthesia
• American Society of Anesthesiologists Physical Status: I - III
• Age 18 to 90 years

Exclusion Criteria

• Combined regional and general anesthesia
• Expected surgery duration < 30 minutes
• Central nervous system (CNS) diseases (dementia, cerebrovascular accident, seizures, psychiatric diseases)
• Regular intake of CNS active drugs (benzodiazepines, antidepressants, antipsychotics, anticonvulsants)
• Heart surgery on cardio-pulmonary bypass
• Relevant hepatic disease (Child B or higher)
• BMI >35
• Overt signs of alcohol abuse
• Contraindications or allergies to drugs used in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anesthesia Quality Score	up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU)	Anesthesia Quality Score (AQS) is defined as the percentage of time the BIS is within the range of 40-60 AND the mean arterial pressure is within the range of 60-80 mmHg.

Secondary Outcome Measures

Name	Time	Method
Total anesthetic drug doses	up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU)
Early postoperative pain control measured by visual analog scale and total morphine dose	up to 1 day From end of surgery (skin closure) until discharge from post-anesthesia care unit (PACU)	Assess the adequacy of pain control during the early postoperative stage, measured by the visual analog scale and the total dose of morphine immediately postoperatively and during PACU stay.
Mean intra-operative Noxious Stimulation Response Index (NSRI)	1 day During surgery (until skin closure)	The Noxious Stimulation Response Index (NSRI) is based on a hierarchical interaction propofol-remifentanil model. With this model, the predicted propofol and remifentanyl concentrations can make a prediction about a respons to a certain stimulus, such as shaking and shouting, or a noxious stimulus.
Number of doses of vasoactive substances	up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU)	The number of doses of vasoactive substances given to maintain an adequate perfusion pressure.
Number of events with motor and vegetative (tearing, sweating) responses	up to 1 week From start of induction until discharge from post-anesthesia care unit	The total number of events in which the patient displays vegetative reactions such as tearing and sweating, in respons to a noxious stimulus during surgery.
Workload of anesthesist, measured by the NASA Taskload Index	up to 1 day From start of induction until transportation to PACU	Assess the workload the anesthetist experiences while working with the Smart Pilot View
Recovery times (skin closure to extubation; skin closure to orientation)	up to 1 week From end of surgery (skin closure) until discharge from post-anesthesia care unit (PACU)	The time it takes for the patient to recover from anesthesia: the time from skin closure until the patient is sufficiently awake to be extubated, and the time from skin closure until full orientation of the patient.

Trial Locations

Locations (2)

University Medical Center Groningen (UMCG); 🇳🇱 Groningen, Netherlands

University Hospital of Bern; 🇨🇭 Bern, Switzerland