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NCT03962036 Clinical Trial

Effect of One-lung Ventilation on BIS Values

Surgery Clinical Trial

Official title:
Effect of One-lung Ventilation on BIS Values

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03962036
Other study ID # STUDY00000324
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date October 11, 2019
Est. completion date December 3, 2021

Study information
Verified date December 2021
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 8
Est. completion date December 3, 2021
Est. primary completion date December 3, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients coming for thoracic surgery with anticipated need for lung isolation Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Christopher McKee

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.)
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