Comparison of Adequacy of Anesthesia Monitoring With Stan... | NCT01928875

Studies
Comparison of Adequacy of Anesthesia Monitoring With Standard Clinical Practice During Routine General Anesthesia

NCT01928875

Sponsor

GE Healthcare

Status

Completed

Last Update Posted

May 1, 2017Actual

Enrollment

496Actual

Phase

Not Applicable

Conditions

Surgical Procedure, Unspecified

Interventions

AoA Monitoring
Routine (Standard) Anesthesia Monitoring

Countries

Finland
Germany
Hungary
Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Feb 1, 2017Actual

Completion Date

Not provided

First Submitted Date

Aug 19, 2013

First Submission Date that Met QC Criteria

Aug 22, 2013

First Posted Date

Aug 27, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2017

Last Update Posted Date

May 1, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to demonstrate that using Surgical Pleth Index (SPI) and Entropy in adjunct to other clinical information decreases the occurrence rate of inadequate anesthesia events, bradycardia and hypotension in comparison to standard clinical practice during anesthesia. Adequacy of Anesthesia (AoA) monitoring comprises the use of both Entropy and SPI measurements. Adequacy of anesthesia will be monitored using non-invasive blood pressure, blood oxygen saturation (SpO2), ECG, and neuromuscular transmission (NMT).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

496Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adequacy of Anesthesia (AoA) Monitoring	Experimental	Adequacy of Anesthesia monitoring with SPI and Entropy	Device: AoA Monitoring
Routine (Standard) Anesthesia Monitoring	Active Comparator		Device: Routine (Standard) Anesthesia Monitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AoA Monitoring	Device	Monitoring with Entropy and SPI parameters during surgery	Adequacy of Anesthesia (AoA) Monitoring

Measure	Description	Time Frame
Incidence of hemodynamic instability	Incidence of hemodynamic instability including hypertension, hypotension, tachycardia, and bradycardia	Participants will be followed for the duration of their surgery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ability to provide written informed consent
Age 18-80 years of age
Surgery that is expected to last at least 2 hours under general anesthesia with endotracheal tube

Exclusion Criteria:

Any subject that meets the definition of vulnerable subject as defined in ISO 14155:2011
Per ISO 14155:2011, a vulnerable subject is defined as an individual whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate
Any subject with a cardiac pacemaker
Any subject with atrial fibrillation at the time of obtaining the baseline values
Any subject with more than 5 ventricular extra systoles/minute at the time of obtaining the baseline values
Any subject who needs invasive blood pressure measurement
Any subject who show hemodynamics that would have qualified for being considered as a sign of inadequate anesthesia already at baseline:
Mean blood pressure below 60 mmHg or above 100 mmHg
HR below 45 /min or above 100/min
Any subject with epidural anesthesia or analgesia during the surgery. Epidural catheter may be placed pre-operatively, and used in the PACU, but not during the surgery
Any subject having surgery that requires prone position
Any subject with very high body mass index (>35) because of incompatibility with the target controlled anesthesia models used
Any subject with known allergies to the specific anesthetic agents/ analgesic drugs intended for use in their surgeries
Any subject with laryngeal mask airway
Any subject who requires neuromuscular blocking agent infusion
Any subject who is going to have major surgery with a high risk of extensive blood loss
Any subject with known chronic use of opioids

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Tampere University Hospital		Tampere			Finland
University Hospital Schleswig-Holstein

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33074943	Derived	Gruenewald M, Harju J, Preckel B, Molnar Z, Yli-Hankala A, Rosskopf F, Koers L, Orban A, Bein B; AoA Study Group. Comparison of adequacy of anaesthesia monitoring with standard clinical practice monitoring during routine general anaesthesia: An international, multicentre, single-blinded randomised controlled trial. Eur J Anaesthesiol. 2021 Jan;38(1):73-81. doi: 10.1097/EJA.0000000000001357.