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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia,General

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands
    • University Medical Center Groningen (UMCG)
• Switzerland
  • Bern, Switzerland
    • University Hospital of Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery under general anesthesia scheduled for neurosurgery, gynecology and ear nose and throat surgery.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Baseline; Baseline group in which patients are anesthetized without the use of Smart Pilot View, according to common practice.
Smart Pilot View Group; Study group in which patients are anesthetized with the use of Smart Pilot View.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anesthesia Quality Score	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.	up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total anesthetic drug doses		up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU)
Mean intra-operative Noxious Stimulation Response Index (NSRI)	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.	1 day During surgery (until skin closure)
Number of doses of vasoactive substances	The number of doses of vasoactive substances given to maintain an adequate perfusion pressure.	up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU)
Number of events with motor and vegetative (tearing, sweating) responses	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.	up to 1 week From start of induction until discharge from post-anesthesia care unit
Recovery times (skin closure to extubation; skin closure to orientation)	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.	up to 1 week From end of surgery (skin closure) until discharge from post-anesthesia care unit (PACU)
Early postoperative pain control measured by visual analog scale and total morphine dose	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.	up to 1 day From end of surgery (skin closure) until discharge from post-anesthesia care unit (PACU)
Workload of anesthesist, measured by the NASA Taskload Index	Assess the workload the anesthetist experiences while working with the Smart Pilot View	up to 1 day From start of induction until transportation to PACU

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: Insel Gruppe AG, University Hospital Bern

Publications and helpful links

General Publications

• Kuizenga MH, Vereecke HEM, Absalom AR, Bucher CH, Hannivoort LN, van den Berg JP, Schmalz L, Struys MMRF, Luginbuhl M. Utility of the SmartPilot(R) View advisory screen to improve anaesthetic drug titration and postoperative outcomes in clinical practice: a two-centre prospective observational trial. Br J Anaesth. 2022 Jun;128(6):959-970. doi: 10.1016/j.bja.2022.02.033. Epub 2022 Mar 28.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: September 14, 2011
• First Submitted That Met QC Criteria: November 3, 2011
• First Posted (Estimated): November 8, 2011

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Recovery; Anesthesia; Pain control; Smart Pilot View
• Other Study ID Numbers: SPV_Utility_V7