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Total Shoulder Arthroplasty Near-infrared Spectroscopy (TSA NIRS)

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ClinicalTrials.gov Identifier: NCT02198183
Recruitment Status : Completed
First Posted : July 23, 2014
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Brief Summary:

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.


Condition or disease Intervention/treatment
Cerebral Ischemia Device: Casmed Fore-Sight Elite Device: Non-invasive Cardiac Output Monitor (NICOM)

Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effects of Positive-pressure Ventilation on Cerebral Oxygenation and Cardiac Output in Total Shoulder Arthroplasty.
Study Start Date : July 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : October 2015

Group/Cohort Intervention/treatment
Near-infrared spectroscopy
Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM)
Device: Casmed Fore-Sight Elite
Device: Non-invasive Cardiac Output Monitor (NICOM)



Primary Outcome Measures :
  1. Cerebral Desaturation Events [ Time Frame: On day of surgery ]
    The primary outcome is defined as cerebral desaturation events (CDE) by >20% from baseline that lasts for 90 seconds or longer.


Secondary Outcome Measures :
  1. Cardiac Output (CO) [ Time Frame: Day of surgery ]
  2. Cardiac Index (CI) [ Time Frame: Day of surgery ]
  3. Stroke Volume (SV) [ Time Frame: Day of surgery ]
  4. Mean Arterial Pressure (MAP) [ Time Frame: Day of surgery ]
  5. Fraction of inspired oxygen (FIO2) [ Time Frame: Day of surgery ]
  6. End Tidal Carbon Dioxide (ETCO2) [ Time Frame: Day of surgery ]
  7. Intravenous fluid volume [ Time Frame: Day of surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Total shoulder arthroplasty patients who are receiving surgery at the Hospital for Special Surgery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198183


Locations
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Principal Investigator: Jacques T YaDeau, MD, PhD Hospital for Special Surgery, New York

Publications:
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT02198183     History of Changes
Other Study ID Numbers: 2014-003
First Posted: July 23, 2014    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Ischemia
Brain Ischemia
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Stroke