Pupillometry for Pain Assessment in Critically Ill Patients

Acute Pain Clinical Trial

Official title:

Pupillometry for Pain Assessment in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02576132
• Other study ID #: Vola-ICU
• Status: Completed
• Phase: N/A
• First received: October 9, 2015
• Last updated: October 13, 2015
• Start date: November 2011
• Est. completion date: October 2012

Study information

• Verified date: October 2015
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Pain
• Critical Illness

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Minimal pupil size [mm]		Participants will be followed up to 6 days during their intensive care unit stay	No
Secondary	Maximal pupil size [mm]		Participants will be followed up to 6 days during their intensive care unit stay	No
Secondary	Contraction speed of pupil [mm/s]		Participants will be followed up to 6 days during their intensive care unit stay	No
Secondary	Latency of pupil [ms]		Participants will be followed up to 6 days during their intensive care unit stay	No
Secondary	Pupillary light reflex [%]		Participants will be followed up to 6 days during their intensive care unit stay	No
Secondary	Richmond Agitation Sedation Scale (RASS)		Participants will be followed up to 6 days during their intensive care unit stay	No
Secondary	Glasgow Coma Scale (GCS)		Participants will be followed up to 6 days during their intensive care unit stay	No
Secondary	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	No
Secondary	Duration of mechanical ventilation (hours)		Participants will be followed up during their intensive care unit stay, an average of 25 days	No
Secondary	Intensive care unit length of stay (days)		Participants will be followed up during their intensive care unit stay, an average of 25 days	No
Secondary	Hospital length of stay (days)		Participants will be followed up during their hospital length of stay, an average of 5 weeks	No
Secondary	Hospital mortality (days)		Participants will be followed up during their hospital length of stay, an average of 5 weeks	No
Secondary	Discharge to home [%]		Participants will be followed up during their hospital length of stay, an average of 5 weeks	No
Secondary	Morbidity Scores		Participants will be followed up during their intensive care unit stay, an average of 25 days	No
Secondary	Amount of administered drugs		Participants will be followed up to 6 days during their intensive care unit stay	No