Reliability of BIS Monitoring in Neurosurgical Patients | NCT01483547

Studies
Reliability of BIS Monitoring in Neurosurgical Patients

NCT01483547

Sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Status

Completed

Last Update Posted

Feb 18, 2013Estimated

Enrollment

405Actual

Phase

Not provided

Conditions

Sovra and Intra Tentorial Lesions

Interventions

Bispectral Index (BIS Vista, Covidien)

Countries

Italy

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

Feb 2013

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

Nov 2011

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Nov 25, 2011

First Submission Date that Met QC Criteria

Nov 29, 2011

First Posted Date

Dec 1, 2011Estimated

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

Feb 15, 2013

Last Update Posted Date

Feb 18, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Carla Carozzi, MD, Doctor, Dept. of Neuroanesthesia and Intensive Care, Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaPrincipal Investigator

Lead Sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 aim of the study is to assess the reliability of Bispectral Index (BIS Vista , Covidien) in neurosurgical patients . BIS values at Loss of Consciousness (LOC), Post Intubation (PI) and Return of Consciousness (ROC) in neurosurgical patients are compared to those of non-neurosurgical patients, during routine anesthesia procedures.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

405Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Neurosurgical			Device: Bispectral Index (BIS Vista, Covidien)
Non-neurosurgical			Device: Bispectral Index (BIS Vista, Covidien)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bispectral Index (BIS Vista, Covidien)	Device	BIS values at LOC, PI, ROC.	Neurosurgical Non-neurosurgical

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
BIS values at LOC, PI and ROC		8 months

Secondary Outcomes

Measure	Description	Time Frame
incidence of intraoperative awareness	intraoperative awareness assessed by BRICE Interview	0, 1, 3, 30 days after surgery
incidence of postoperative delirium	assessed by Nursing Delirium Scale and CAM-ICU.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BIS > 90 at baseline (awake)
ASA I or II

Exclusion Criteria:

GSC < 15
anticipated difficult ventilation and/or intubation
BMI > 30
surgical site that does not allow BIS monitoring
bilateral hearing loss
not speaking Italian Language

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

patients undergoing elective craniotomy and elective spinal cord and column surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istituto Neurologico Carlo Besta		Milan	Milan	20133	Italy