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Effect of One-lung Ventilation on BIS Values

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03962036
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Information provided by (Responsible Party):
Christopher McKee, Nationwide Children's Hospital

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.

Condition or disease Intervention/treatment
Surgery Thoracic Device: Bispectral index monitor

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of One-lung Ventilation on BIS Values
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Intervention Details:
  • 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.
    Other Name: BIS

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Surgical patients requiring one lung ventilation at Nationwide Children's Hospital.

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03962036

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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Christopher McKee

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Responsible Party: Christopher McKee, Attending Anesthesiologist, Nationwide Children's Hospital Identifier: NCT03962036     History of Changes
Other Study ID Numbers: STUDY00000324
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No