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SPI Value Relevance in Clinical Practice

NCT02074475 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2017-05-05

No results posted yet for this study

Summary

Primary endpoint: Defining The optimal target range for Surgical Pleth index. Surgical Pleth Index (SPI, formerly used SSI = Surgical Stress Index) is a novel multivariate index, which is based on the sum of the normalized pulse beat interval (PBI) and the photoplethysmography. SPI indicates the balance between intensity of surgical stimulation and the level of anti-nociception (opioid analgesia and neural blockade). This study is a Spin off from a larger Adequacy of Anaesthesia study and aims on finding the most appropriate target range for SPI in order to avoid signs of inadequate anaesthesia. Patients are treated without monitoring adequacy of anaesthesia thus the values are collected blinded and analyzed afterwards in accordance of signs for inadequate anaesthesia. The study population will be 150 patients.

Conditions

  • Anesthesia

Interventions

OTHER

Control group

A group of no Monitoring patients from larger AoA study with no adequacy of anaesthesia monitoring

Sponsors & Collaborators

  • Tampere University Hospital

    lead OTHER

Principal Investigators

  • Jarkko Harju, MD · Tampere University Hospital

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02074475 on ClinicalTrials.gov