Pupillometry for Pain Assessment in Critically Ill Patients

Study Overview
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Brief Summary
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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.

Official Title
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Pupillometry for Pain Assessment in Critically Ill Patients

Conditions
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Acute Pain

Participation Criteria
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Eligibility Criteria
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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 stroke increased intracranial pressure ocular disease or surgery.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation coefficient of pupillary light reflex amplitude and pain score | 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 | Participants will be followed up to 6 days during their intensive care unit stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Contraction speed of pupil [mm/s] |  | Participants will be followed up to 6 days during their intensive care unit stay | 
| Latency of pupil [ms] |  | 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 | 
| Richmond Agitation Sedation Scale (RASS) |  | Participants will be followed up to 6 days during their intensive care unit stay | 
| Glasgow Coma Scale (GCS) |  | Participants will be followed up to 6 days during their intensive care unit stay | 
| Delirium | Delirium is measured by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) | 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 | 
| 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 | 
| Morbidity Scores |  | 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 |