Changes in Cerebral Oxygenation Based on Intraoperative Ventilation Strategy

NCT02651103 | Completed Results

• 1 other identifier: IRB15-01073
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Posterior Spinal Fusion

Outcome Measures

Primary Outcomes (1)

• Change in Cerebral Oxygenation Values Throughout the Procedure

  Measured on the NIRS cerebral oxygenation monitor attached to the patient

  prior to induction of anesthesia in the awake patient and following four ventilation strategies (average time frame of 15 mins. to 5 hours)

Study Arms (1)

Posterior spinal fusion

Patients undergoing spinal fusion surgery

Device: NIRS

Interventions

NIRS DEVICE

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

Posterior spinal fusion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing posterior spinal fusion

You may qualify if:

• Any patient undergoing spinal surgery

You may not qualify if:

• None

Sponsors & Collaborators

• Joseph D. Tobias: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Results Point of Contact

• Title: Clinical Research Coordinator
• Organization: Nationwide Children's Hospital

heather.dellinger@nationwidechildrens.org

6147222997

Study Officials

• Joseph D Tobias, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chairman: Professor of Anesthesiology

Study Record Dates

• First Submitted: January 7, 2016
• First Posted: January 8, 2016
• Study Start: January 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: October 15, 2018
• Results First Posted: October 15, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)