Clinical trial NCT02576132: Pupillometry for Pain Assessment in Critically Ill Patients
Official title: Pupillometry for Pain Assessment in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pain
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2015-10-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients, aged 18 years or older with an expected intensive care unit length of stay of of at least 48 hours.

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.


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
* stroke
* increased intracranial pressure
* ocular disease or surgery.

Primary outcomes:
measure: Correlation coefficient of pupillary light reflex amplitude and pain score
timeFrame: Participants will be followed up to 6 days during their intensive care unit stay
Secondary outcomes:
measure: Minimal pupil size [mm]
timeFrame: Participants will be followed up to 6 days during their intensive care unit stay
measure: Maximal pupil size [mm]
timeFrame: Participants will be followed up to 6 days during their intensive care unit stay
measure: Contraction speed of pupil [mm/s]
timeFrame: Participants will be followed up to 6 days during their intensive care unit stay
measure: Latency of pupil [ms]
timeFrame: Participants will be followed up to 6 days during their intensive care unit stay
measure: Pupillary light reflex [%]
timeFrame: Participants will be followed up to 6 days during their intensive care unit stay
measure: Richmond Agitation Sedation Scale (RASS)
timeFrame: Participants will be followed up to 6 days during their intensive care unit stay
measure: Glasgow Coma Scale (GCS)
timeFrame: Participants will be followed up to 6 days during their intensive care unit stay
measure: Delirium
timeFrame: Participants will be followed up to 6 days during their intensive care unit stay
measure: Duration of mechanical ventilation (hours)
timeFrame: Participants will be followed up during their intensive care unit stay, an average of 25 days
measure: Intensive care unit length of stay (days)
timeFrame: Participants will be followed up during their intensive care unit stay, an average of 25 days
measure: Hospital length of stay (days)
timeFrame: Participants will be followed up during their hospital length of stay, an average of 5 weeks
measure: Hospital mortality (days)
timeFrame: Participants will be followed up during their hospital length of stay, an average of 5 weeks
measure: Discharge to home [%]
timeFrame: Participants will be followed up during their hospital length of stay, an average of 5 weeks
measure: Morbidity Scores
timeFrame: Participants will be followed up during their intensive care unit stay, an average of 25 days
measure: Amount of administered drugs
timeFrame: Participants will be followed up to 6 days during their intensive care unit stay
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine
Study officials:
affiliation: Charité - Univeritätsmedizin Berlin
name: Claudia Spies, MD Prof.
role: STUDY_DIRECTOR
References: