Changes in Cerebral Oxygenation Based on Intraoperative Ventilation Strategy

Posterior Spinal Fusion Clinical Trial

Official title:

Changes in Cerebral Oxygenation Based on Intraoperative Ventilation Strategy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02651103
• Other study ID #: IRB15-01073
• Status: Completed
• Start date: January 2016
• Est. completion date: August 2017

Study information

• Verified date: December 2017
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Any patient undergoing spinal surgery

Exclusion Criteria:

Related Conditions & MeSH terms

• Posterior Spinal Fusion

Intervention

Device:
• NIRS
Cerebral oxygenation monitor which is standard of care for this surgery.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Joseph D. Tobias

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)