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NCT02198183 · ClinicalTrials.gov registry record
Total Shoulder Arthroplasty Near-infrared Spectroscopy
A clinical trial of Cerebral Ischemia, sponsored by Hospital for Special Surgery, New York.
- Completed
- Registry status
- 34
- Enrollment target
- 1
- Study location
NCT02198183: Completed study of Cerebral Ischemia, sponsored by Hospital for Special Surgery, New York.
NCT02198183 is a study of Cerebral Ischemia that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 34 participants, below the 15,136-participant average among 4 other Cerebral Ischemia trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02198183, a study of Cerebral Ischemia, has completed, sponsored by Hospital for Special Surgery, New York.
- COMPLETED
- Registry status
- 34 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Casmed Fore-Sight Elite
- DEVICE Non-invasive Cardiac Output Monitor (NICOM)
Study Locations (1)
New York
- Hospital for Special Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2014-07 |
| Est. Completion | 2015-10 |
What the finished NCT02198183 record still lists
NCT02198183 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 15,136-participant average among 4 other Cerebral Ischemia trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Cerebral Ischemia appearing as the primary indexed condition, and to 2 interventions - of which Casmed Fore-Sight Elite is the first listed.
NCT02198183 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02198183 about?
NCT02198183 is a clinical study titled "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 an...
What is the current status of trial NCT02198183?
This trial is currently completed. The enrollment target is 34 participants. The study started on 2014-07. Estimated completion is 2015-10.
What conditions does trial NCT02198183 study?
This clinical trial studies the following conditions: Cerebral Ischemia.
What interventions are being tested in trial NCT02198183?
The interventions under investigation include: Casmed Fore-Sight Elite (DEVICE), Non-invasive Cardiac Output Monitor (NICOM) (DEVICE).
Who is sponsoring clinical trial NCT02198183?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02198183 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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