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

Anesthesia,General Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01467167
• Other study ID #: SPV_Utility_V7
• Status: Completed
• Start date: October 2011
• Est. completion date: October 2017

Study information

• Verified date: April 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia,General

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen (UMCG)	Groningen
Switzerland	University Hospital of Bern	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	Insel Gruppe AG, University Hospital Bern

Countries where clinical trial is conducted

Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total anesthetic drug doses		up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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