Skip to main content
OpenTrials
Completed

NCT Number: NCT02198183

Total Shoulder Arthroplasty Near-infrared Spectroscopy

The purpose of this study is to measure cerebral oxygenation and cardiac output of total shoulder replacement patients undergoing general anesthesia (GA) and positive-pressure ventilation (PPV).

We hypothesize that cerebral desaturation occurs frequently during GA with PPV, but is rare during GA and spontaneous ventilation. We also hypothesize that cardiac output usually is well maintained under GA in the sitting position when epinephrine is used, but that decreased cardiac output increases the risk of cerebral desaturation.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cerebral Ischemia Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients 18-99 undergoing total shoulder arthroplasty
  • Planned general anesthesia + brachial plexus nerve block
  • Planned arterial catheter

Exclusion criteria

  • Patients younger than 18 years older and older than 99
  • Patients not intending to receive general anesthesia and peripheral nerve block
  • Indication for endotracheal tube
  • BMI ≥ 30
  • Ejection Fraction (if known) < 50%
  • Known significant restrictive or obstructive pulmonary disease
  • Patients with a history of transient ischemic attack (TIA) or stroke
  • Patients with recent signs or symptoms of myocardial ischemia
  • Current stress test positive for ischemia
  • Intolerance to study medications
  • pre-existing contraindication to regional anesthesia
  • infection at block site
  • pre-existing neurological injury to operative limb
  • Non-English speaking patients

Treatment and study plan

Casmed Fore-Sight Elite

Device

Non-invasive Cardiac Output Monitor (NICOM)

Device

Primary outcomes

  1. Number of Cerebral Desaturation Events

    Time frame: Day of surgery

    The number of Cerebral Desaturation Events (CDE) that occured. CDE is defined as a reduction in cerebral tissue oxygen saturation of >20% from baseline that lasts for 90 seconds or longer.

Secondary outcomes

  1. Cardiac Output (CO)

    Time frame: Day of surgery

    Cardiac output of patients as measured in liters per minute

  2. Cardiac Index (CI)

    Time frame: Day of surgery

    Average cardiac index for patients, a measurement of how efficient the heart is pumping. Measured in liters per minute per meters squared of heart size.

  3. Stroke Volume (SV)

    Time frame: Day of surgery

    Stroke volume, the amount of blood pumped by the left ventricle of the heart with each contraction. Measured in milliliters.

  4. Mean Arterial Pressure (MAP)

    Time frame: Day of surgery

    mean arterial pressure and noninvasive blood pressure will be represented as a percentage of baseline after surgery. A lower percentage is a worse outcome.

  5. End Tidal Carbon Dioxide (ETCO2)

    Time frame: Day of surgery

    a lower score is a better outcome.

  6. Intravenous Fluid Volume

    Time frame: Day of surgery

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

The Effects of Positive-pressure Ventilation on Cerebral Oxygenation and Cardiac Output in Total Shoulder Arthroplasty.

Acronym: TSA NIRS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 23, 2014
Registry last updated
Jan 17, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.