Effect of One-lung Ventilation on BIS Values

December 6, 2021 updated by: Christopher McKee
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BIS
Time Frame: From baseline to one lung ventilation (average time frame of 30 mins. - 1 hr.)
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.)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christopher McKee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2019

Primary Completion (Actual)

December 3, 2021

Study Completion (Actual)

December 3, 2021

Study Registration Dates

First Submitted

May 22, 2019

First Submitted That Met QC Criteria

May 22, 2019

First Posted (Actual)

May 23, 2019

Study Record Updates

Last Update Posted (Actual)

December 20, 2021

Last Update Submitted That Met QC Criteria

December 6, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00000324

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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