Cerebral IschemiaTSA NIRSNCT02198183
Total Shoulder Arthroplasty Near-infrared Spectroscopy
An observational study of Cerebral Ischemia, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Ischemia
- What is being tested?
- Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM)
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Oct 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Total shoulder arthroplasty patients who are receiving surgery at the Hospital for Special Surgery
Who may be able to join
- Patients 18-99 undergoing total shoulder arthroplasty
- Planned general anesthesia + brachial plexus nerve block
- Planned arterial catheter
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: The Effects of Positive-pressure Ventilation on Cerebral Oxygenation and Cardiac Output in Total Shoulder Arthroplasty.
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.
- Conditions
- Cerebral Ischemia
- Being tested
- Casmed Fore-Sight Elite, Non-invasive Cardiac Output Monitor (NICOM)
- Medical subject headings
- Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Casmed Fore-Sight EliteDevice
Non-invasive Cardiac Output Monitor (NICOM)Device
| Study group | Role | What they receive |
|---|---|---|
| Near-infrared spectroscopy | Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM) Receives: Device: Casmed Fore-Sight Elite; Device: Non-invasive Cardiac Output Monitor (NICOM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Cerebral Desaturation Events
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.
Measured: Day of surgery
Secondary outcomes (6)
Cardiac Output (CO)
Cardiac output of patients as measured in liters per minute
Measured: Day of surgery
Cardiac Index (CI)
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.
Measured: Day of surgery
Stroke Volume (SV)
Stroke volume, the amount of blood pumped by the left ventricle of the heart with each contraction. Measured in milliliters.
Measured: Day of surgery
Mean Arterial Pressure (MAP)
mean arterial pressure and noninvasive blood pressure will be represented as a percentage of baseline after surgery. A lower percentage is a worse outcome.
Measured: Day of surgery
End Tidal Carbon Dioxide (ETCO2)
a lower score is a better outcome.
Measured: Day of surgery
Intravenous Fluid Volume
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebral IschemiaStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques T YaDeau, MD, PhD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198183
- Sponsor's protocol ID
- 2014-003
- Acronym
- TSA NIRS
- Status last verified
- Apr 2022
- First submitted
- 16 Jul 2014
- Last updated
- 17 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Friedman DJ, Parnes NZ, Zimmer Z, Higgins LD, Warner JJ. Prevalence of cerebrovascular events during shoulder surgery and association with patient position. Orthopedics. 2009 Apr;32(4):orthosupersite.com/view.asp?rID=38058.
PubMed 19388618Yadeau JT, Casciano M, Liu SS, Edmonds CR, Gordon M, Stanton J, John R, Shaw PM, Wilfred SE, Stanton M. Stroke, regional anesthesia in the sitting position, and hypotension: a review of 4169 ambulatory surgery patients. Reg Anesth Pain Med. 2011 Sep-Oct;36(5):430-5. doi: 10.1097/AAP.0b013e318228d54e.
PubMed 21857267Yadeau JT, Liu SS, Bang H, Shaw PM, Wilfred SE, Shetty T, Gordon M. Cerebral oximetry desaturation during shoulder surgery performed in a sitting position under regional anesthesia. Can J Anaesth. 2011 Nov;58(11):986-92. doi: 10.1007/s12630-011-9574-7. Epub 2011 Aug 25.
PubMed 21866430Koh JL, Levin SD, Chehab EL, Murphy GS. Neer Award 2012: cerebral oxygenation in the beach chair position: a prospective study on the effect of general anesthesia compared with regional anesthesia and sedation. J Shoulder Elbow Surg. 2013 Oct;22(10):1325-31. doi: 10.1016/j.jse.2013.01.035. Epub 2013 Apr 6.
PubMed 23571083
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Positive-pressure Ventilation on Cerebral Oxygenation and Cardiac Output in Total Shoulder Arthroplasty.
- ClinicalTrials.gov ID
- NCT02198183
- Acronym / sponsor ID
- TSA NIRS / 2014-003
- Conditions
- Cerebral Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 23 Jul 2014 (estimated)
- Results
- Posted 17 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Near-infrared spectroscopy | – | Device: Casmed Fore-Sight Elite, Device: Non-invasive Cardiac Output Monitor (NICOM)Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Total shoulder arthroplasty patients who are receiving surgery at the Hospital for Special Surgery
Key inclusion criteria (3 listed)
- Patients 18-99 undergoing total shoulder arthroplasty
- Planned general anesthesia + brachial plexus nerve block
- Planned arterial catheter
Key exclusion criteria (14 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Casmed Fore-Sight Elite | Device | Near-infrared spectroscopy |
| Non-invasive Cardiac Output Monitor (NICOM) | Device | Near-infrared spectroscopy |
Primary outcome
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.
6 secondary outcomes
Cardiac Output (CO)
Time frame: Day of surgery
Cardiac Index (CI)
Time frame: Day of surgery
Stroke Volume (SV)
Time frame: Day of surgery
Mean Arterial Pressure (MAP)
Time frame: Day of surgery
End Tidal Carbon Dioxide (ETCO2)
Time frame: Day of surgery
Intravenous Fluid Volume
Time frame: Day of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19388618Friedman DJ, Parnes NZ, Zimmer Z, Higgins LD, Warner JJ. Prevalence of cerebrovascular events during shoulder surgery and association with patient position. Orthopedics. 2009 Apr;32(4):orthosupersite.com/view.asp?rID=38058.
- Background: PubMed 21857267Yadeau JT, Casciano M, Liu SS, Edmonds CR, Gordon M, Stanton J, John R, Shaw PM, Wilfred SE, Stanton M. Stroke, regional anesthesia in the sitting position, and hypotension: a review of 4169 ambulatory surgery patients. Reg Anesth Pain Med. 2011 Sep-Oct;36(5):430-5. doi: 10.1097/AAP.0b013e318228d54e.
- Background: PubMed 21866430Yadeau JT, Liu SS, Bang H, Shaw PM, Wilfred SE, Shetty T, Gordon M. Cerebral oximetry desaturation during shoulder surgery performed in a sitting position under regional anesthesia. Can J Anaesth. 2011 Nov;58(11):986-92. doi: 10.1007/s12630-011-9574-7. Epub 2011 Aug 25.
- Background: PubMed 23571083Koh JL, Levin SD, Chehab EL, Murphy GS. Neer Award 2012: cerebral oxygenation in the beach chair position: a prospective study on the effect of general anesthesia compared with regional anesthesia and sedation. J Shoulder Elbow Surg. 2013 Oct;22(10):1325-31. doi: 10.1016/j.jse.2013.01.035. Epub 2013 Apr 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques T YaDeau, MD, PhD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Ischemia, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Cerebral Desaturation Events (time frame: Day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02198183, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.