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COMPLETED

Total Shoulder Arthroplasty Near-infrared Spectroscopy

NCT02198183 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 34 participants
Start Date 2014-07
Est. Completion 2015-10

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02198183

The ClinicalTrials.gov registry entry for NCT02198183 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hospital for Special Surgery, New York, which has 141 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02198183 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02198183?

This trial is sponsored by Hospital for Special Surgery, New York, which has 141 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial