Pupillometry for Pain Assessment in Critically Ill Patients

NCT02576132 | Completed

• 1 other identifier: Vola-ICU
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

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

Berlin, State of Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Claudia Spies, MD Prof.

  Charité - Univeritätsmedizin Berlin

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Anesthesiology and Intensive Care Medicine CVK/CCM

Study Record Dates

• First Submitted: October 9, 2015
• First Posted: October 15, 2015
• Study Start: November 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 15, 2015

Record last verified: 2015-10

Locations

DE (1)