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Completed

NCT Number: NCT02576132

Pupillometry for Pain Assessment in Critically Ill Patients

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.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine

Berlin, State of Berlin, 13353, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Minimal pupil size [mm]

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

  2. Maximal pupil size [mm]

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

  3. Contraction speed of pupil [mm/s]

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

  4. Latency of pupil [ms]

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

  5. Pupillary light reflex [%]

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

  6. Richmond Agitation Sedation Scale (RASS)

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

  7. Glasgow Coma Scale (GCS)

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

  8. Delirium

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

    Delirium is measured by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)

  9. Duration of mechanical ventilation (hours)

    Time frame: Participants will be followed up during their intensive care unit stay, an average of 25 days

  10. Intensive care unit length of stay (days)

    Time frame: Participants will be followed up during their intensive care unit stay, an average of 25 days

  11. Hospital length of stay (days)

    Time frame: Participants will be followed up during their hospital length of stay, an average of 5 weeks

  12. Hospital mortality (days)

    Time frame: Participants will be followed up during their hospital length of stay, an average of 5 weeks

  13. Discharge to home [%]

    Time frame: Participants will be followed up during their hospital length of stay, an average of 5 weeks

  14. Morbidity Scores

    Time frame: Participants will be followed up during their intensive care unit stay, an average of 25 days

  15. Amount of administered drugs

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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 15, 2015
Registry last updated
Oct 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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