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

NCT ID: NCT01467167

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2017-10-31

Brief Summary

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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

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Conditions

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Anesthesia,General

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Baseline

Baseline group in which patients are anesthetized without the use of Smart Pilot View, according to common practice.

No interventions assigned to this group

Smart Pilot View Group

Study group in which patients are anesthetized with the use of Smart Pilot View.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Medical Center Groningen (UMCG)

Groningen, , Netherlands

Site Status

University Hospital of Bern

Bern, , Switzerland

Site Status

Countries

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Netherlands Switzerland

References

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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.

Reference Type DERIVED
PMID: 35361490 (View on PubMed)

Other Identifiers

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SPV_Utility_V7

Identifier Type: -

Identifier Source: org_study_id

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