Cerebral Oximetry in Single Lung Ventilation Thoracic Surgery

Summary

This is a prospective, randomized controlled pilot study of cerebral oximetry use in elderly patients undergoing thoracic surgical procedures that require the use of single lung ventilation. The hypothesis is that subjects randomized to open cerebral oximetry monitoring that have active intervention to mitigate observed desaturations will have measurable postoperative clinical outcome benefits when compared to the patients randomized to blinded cerebral oximetry monitoring with no active interventions to mitigate desaturations.

Conditions

• Hypoxia

Interventions

DRUG

Vasoconstrictor Agents

cerebral desaturations may be treated with IV vasoactives to increase blood pressure or cardiac output at attending physician's descretion.

OTHER

Head/neck repositioning

Assure that arterial and venous neck blood flow is not obstructed related to patient positioning

OTHER

Increase ETCO2

Allow normalization or slight increase in end tidal CO2 to cause selective cerebral vasodilation and increased tissue blood flow/O2 delivery

OTHER

IV fluid bolus

Administer IV fluids to increase preload and cardiac output

DRUG

Additional anesthesia

By deepening anesthetic there will be a decrease in cerebral metabolic oxygen consumption.

BIOLOGICAL

RBC transfusion

By administering RBCs there will be a increase in intravascular volume and cardiac preload and an increase in oxygen carrying capacity

DRUG

Increase FiO2

Increase FiO2 to improve oxygen delivery to tissue

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center

  lead OTHER

Principal Investigators

• John C Klick, MD · University Hospitals Cleveland Medical Center

• Edwin G Avery, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-06-30

Primary Completion

2016-11-10

Completion

2016-11-10

Countries

• United States

Study Locations