Changes in Cerebral Oxygenation Based on Intraoperative Ventilation Strategy

NCT ID: NCT02651103

Last Updated: 2018-10-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-08-31

Brief Summary

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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).

Detailed Description

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Conditions

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Posterior Spinal Fusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Posterior spinal fusion

Patients undergoing spinal fusion surgery

NIRS

Intervention Type DEVICE

Cerebral oxygenation monitor which is standard of care for this surgery.

Interventions

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NIRS

Cerebral oxygenation monitor which is standard of care for this surgery.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Any patient undergoing spinal surgery

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Joseph D. Tobias

OTHER

Sponsor Role lead

Responsible Party

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Joseph D. Tobias

Chairman: Professor of Anesthesiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Joseph D Tobias, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB15-01073

Identifier Type: -

Identifier Source: org_study_id

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