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Clinical Trials/NCT02576132
NCT02576132
Completed
Not Applicable

Pupillometry for Pain Assessment in Critically Ill Patients

Charite University, Berlin, Germany1 site in 1 country80 target enrollmentNovember 2011
ConditionsAcute Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Pain
Sponsor
Charite University, Berlin, Germany
Enrollment
80
Locations
1
Primary Endpoint
Correlation coefficient of pupillary light reflex amplitude and pain score
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

This study was part of a quality improvement project at the Department of Anesthesiology and Intensive Care Medicine, Charité - Universitaetsmedizin Berlin.

Being in pain is reported to be one of the most important stressors in critically ill patients and worsens outcome. The evaluation of pain using validated scores in patients who are able to self-report significantly improves the quality of analgesic therapy and health related outcomes in intensive care patients.

However, behavioral pain score that are used in sedated or delirious patients, often underestimate the severity of pain.

The primary aim of this study is to investigate if measurement of the pupillary light reflex Amplitude correlates with the results of pain assessment using validated pain scores in critically ill patients.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
October 2012
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Claudia Spies

Head of Department of Anesthesiology and Intensive Care Medicine CVK/CCM

Charite University, Berlin, Germany

Eligibility Criteria

Inclusion Criteria

  • critically ill patients
  • aged 18 years or older
  • patients with an expected intensive care unit length of stay of of at least 48 hours.

Exclusion Criteria

  • not German speaking
  • traumatic brain injury
  • increased intracranial pressure
  • ocular disease or surgery.

Outcomes

Primary Outcomes

Correlation coefficient of pupillary light reflex amplitude and pain score

Time Frame: Participants will be followed up to 6 days during their intensive care unit stay

Pain is measured by Numeric Rating Scale - Visualised or Behavioural Pain Scale or Behavioral Pain Scale - Non Intubated and pupillary light reflex amplitude is measured by pupillometry

Secondary Outcomes

  • Latency of pupil [ms](Participants will be followed up to 6 days during their intensive care unit stay)
  • Minimal pupil size [mm](Participants will be followed up to 6 days during their intensive care unit stay)
  • Maximal pupil size [mm](Participants will be followed up to 6 days during their intensive care unit stay)
  • Pupillary light reflex [%](Participants will be followed up to 6 days during their intensive care unit stay)
  • Morbidity Scores(Participants will be followed up during their intensive care unit stay, an average of 25 days)
  • Glasgow Coma Scale (GCS)(Participants will be followed up to 6 days during their intensive care unit stay)
  • Delirium(Participants will be followed up to 6 days during their intensive care unit stay)
  • Contraction speed of pupil [mm/s](Participants will be followed up to 6 days during their intensive care unit stay)
  • Duration of mechanical ventilation (hours)(Participants will be followed up during their intensive care unit stay, an average of 25 days)
  • Amount of administered drugs(Participants will be followed up to 6 days during their intensive care unit stay)
  • Richmond Agitation Sedation Scale (RASS)(Participants will be followed up to 6 days during their intensive care unit stay)
  • Intensive care unit length of stay (days)(Participants will be followed up during their intensive care unit stay, an average of 25 days)
  • Hospital length of stay (days)(Participants will be followed up during their hospital length of stay, an average of 5 weeks)
  • Hospital mortality (days)(Participants will be followed up during their hospital length of stay, an average of 5 weeks)
  • Discharge to home [%](Participants will be followed up during their hospital length of stay, an average of 5 weeks)

Study Sites (1)

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