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Pupillometry for Pain Assessment in Critically Ill Patients

Pupillometry for Pain Assessment in Critically Ill Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02576132
Enrollment
80
Registered
2015-10-15
Start date
2011-11-30
Completion date
2012-10-31
Last updated
2015-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain

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.

Interventions

None listed

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Correlation coefficient of pupillary light reflex amplitude and pain scoreParticipants will be followed up to 6 days during their intensive care unit stayPain 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

MeasureTime frameDescription
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
DeliriumParticipants will be followed up to 6 days during their intensive care unit stayDelirium is measured by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
Minimal pupil size [mm]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
Morbidity ScoresParticipants will be followed up during their intensive care unit stay, an average of 25 days
Amount of administered drugsParticipants 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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026