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Changes in Cerebral Oxygenation Based on Intraoperative Ventilation Strategy

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02651103
Recruitment Status : Completed
First Posted : January 8, 2016
Results First Posted : October 15, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital

Study Description
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Brief Summary:

The proposed research aims to investigate how different ventilation strategies may affect cerebral tissue oxygenation in the pediatric population. It will contribute to the literature exploring the NIRS monitoring device which is becoming increasingly utilized in a variety of anesthetic and critical care settings. It may help to guide clinical practice regarding optimal ventilation strategies, and how ventilation may be altered to correct suboptimal cerebral tissue oxygenation.

This prospective study will include 50 patients undergoing posterior spinal fusion that requires placement of an arterial cannulation. There will be no change in the anesthetic or perioperative care of these patients. Tissue and cerebral oxygenation will be monitored using near infrared spectroscopy (NIRS).


Condition or disease Intervention/treatment
Posterior Spinal Fusion Device: NIRS

Study Design
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes in Cerebral Oxygenation Based on Intraoperative Ventilation Strategy
Actual Study Start Date : January 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017
Groups and Cohorts
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Group/Cohort Intervention/treatment
Posterior spinal fusion
Patients undergoing spinal fusion surgery
 Device: NIRS
Cerebral oxygenation monitor which is standard of care for this surgery.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Cerebral Oxygenation Values Throughout the Procedure [ Time Frame: prior to induction of anesthesia in the awake patient and following four ventilation strategies (average time frame of 15 mins. to 5 hours) ]
    Measured on the NIRS cerebral oxygenation monitor attached to the patient


Eligibility Criteria
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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
Patients undergoing posterior spinal fusion
Criteria

Inclusion Criteria:

  • Any patient undergoing spinal surgery

Exclusion Criteria:

  • None
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02651103


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Joseph D. Tobias
Investigators
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Principal Investigator: Joseph D Tobias, MD Nationwide Children's Hospital
  Study Documents (Full-Text)

Documents provided by Joseph D. Tobias, Nationwide Children's Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] May 15, 2017

More Information
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Responsible Party: Joseph D. Tobias, Chairman: Professor of Anesthesiology, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02651103    
Other Study ID Numbers: IRB15-01073
First Posted: January 8, 2016    Key Record Dates
Results First Posted: October 15, 2018
Last Update Posted: October 15, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No