NCT03962036

Brief Summary

In this observational study, all enrolled patients having a thoracic surgical procedure requiring lung isolation will have a bispectral index (BIS) monitor placed at time of induction. BIS monitors are used to assist in determining depth of anesthesia. This study will evaluate changes in BIS before, during and after lung isolation.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 23, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

October 11, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2021

Completed
Last Updated

December 20, 2021

Status Verified

December 1, 2021

Enrollment Period

2.1 years

First QC Date

May 22, 2019

Last Update Submit

December 6, 2021

Conditions

SurgeryThoracic

Outcome Measures

Primary Outcomes (1)

  • Change in BIS

    Comparing the BIS readings while on two lung ventilation to the BIS readings after switching the one lung ventilation.

    From baseline to one lung ventilation (average time frame of 30 mins. - 1 hr.)

Interventions

Bispectral index monitorDEVICE

BIS monitor is a novel measure of the level of consciousness by algorithmic analysis of a patient's electroencephalogram during general anesthesia.

Also known as: BIS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surgical patients requiring one lung ventilation at Nationwide Children's Hospital.

You may qualify if:

  • Patients coming for thoracic surgery with anticipated need for lung isolation

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Interventions

Consciousness Monitors

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending Anesthesiologist

Study Record Dates

First Submitted

May 22, 2019

First Posted

May 23, 2019

Study Start

October 11, 2019

Primary Completion

December 3, 2021

Study Completion

December 3, 2021

Last Updated

December 20, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)