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OpenTrials
Completed

NCT Number: NCT02651103

Changes in Cerebral Oxygenation Based on Intraoperative Ventilation Strategy

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).

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Key information

Conditions

Posterior Spinal Fusion

Sex eligibility

All sexes

Study type

Observational

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any patient undergoing spinal surgery

Exclusion criteria

  • None

Treatment and study plan

NIRS

Device

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Joseph D. Tobias

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 8, 2016
Registry last updated
Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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