Acute PainNCT02576132
Pupillometry for Pain Assessment in Critically Ill Patients
An observational study of Acute Pain, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2011to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- critically ill patients
- aged 18 years or older
- patients with an expected intensive care unit length of stay of of at least 48 hours.
Who cannot join
- not German speaking
- traumatic brain injury
- stroke
- increased intracranial pressure
- ocular disease or surgery.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine
Berlin, State of Berlin, 13353
About this study
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.
Read more
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
- Medical subject headings
- Acute Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Participants will be followed up to 6 days during their intensive care unit stay
Secondary outcomes (15)
Minimal pupil size [mm]
Measured: Participants will be followed up to 6 days during their intensive care unit stay
Maximal pupil size [mm]
Measured: Participants will be followed up to 6 days during their intensive care unit stay
Contraction speed of pupil [mm/s]
Measured: Participants will be followed up to 6 days during their intensive care unit stay
Latency of pupil [ms]
Measured: Participants will be followed up to 6 days during their intensive care unit stay
Pupillary light reflex [%]
Measured: Participants will be followed up to 6 days during their intensive care unit stay
Richmond Agitation Sedation Scale (RASS)
Measured: Participants will be followed up to 6 days during their intensive care unit stay
Glasgow Coma Scale (GCS)
Measured: Participants will be followed up to 6 days during their intensive care unit stay
Delirium
Delirium is measured by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
Measured: Participants will be followed up to 6 days during their intensive care unit stay
Duration of mechanical ventilation (hours)
Measured: Participants will be followed up during their intensive care unit stay, an average of 25 days
Intensive care unit length of stay (days)
Measured: Participants will be followed up during their intensive care unit stay, an average of 25 days
Hospital length of stay (days)
Measured: Participants will be followed up during their hospital length of stay, an average of 5 weeks
Hospital mortality (days)
Measured: Participants will be followed up during their hospital length of stay, an average of 5 weeks
Discharge to home [%]
Measured: Participants will be followed up during their hospital length of stay, an average of 5 weeks
Morbidity Scores
Measured: Participants will be followed up during their intensive care unit stay, an average of 25 days
Amount of administered drugs
Measured: Participants will be followed up to 6 days during their intensive care unit stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startNov 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD Prof., Study director, Charité - Univeritätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576132
- Sponsor's protocol ID
- Vola-ICU
- Status last verified
- Oct 2015
- First submitted
- 9 Oct 2015
- Last updated
- 15 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pupillometry for Pain Assessment in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02576132
- Acronym / sponsor ID
- Vola-ICU
- Conditions
- Acute Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 15 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- critically ill patients
- aged 18 years or older
- patients with an expected intensive care unit length of stay of of at least 48 hours.
Key exclusion criteria (5 listed)
- not German speaking
- traumatic brain injury
- stroke
- increased intracranial pressure
- ocular disease or surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
15 secondary outcomes
Minimal pupil size [mm]
Time frame: Participants will be followed up to 6 days during their intensive care unit stay
Maximal pupil size [mm]
Time frame: Participants will be followed up to 6 days during their intensive care unit stay
Contraction speed of pupil [mm/s]
Time frame: Participants will be followed up to 6 days during their intensive care unit stay
Latency of pupil [ms]
Time frame: Participants will be followed up to 6 days during their intensive care unit stay
Pupillary light reflex [%]
Time frame: Participants will be followed up to 6 days during their intensive care unit stay
Richmond Agitation Sedation Scale (RASS)
Time frame: Participants will be followed up to 6 days during their intensive care unit stay
Glasgow Coma Scale (GCS)
Time frame: Participants will be followed up to 6 days during their intensive care unit stay
Delirium
Time frame: Participants will be followed up to 6 days during their intensive care unit stay
Duration of mechanical ventilation (hours)
Time frame: Participants will be followed up during their intensive care unit stay, an average of 25 days
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
Hospital length of stay (days)
Time frame: Participants will be followed up during their hospital length of stay, an average of 5 weeks
Hospital mortality (days)
Time frame: Participants will be followed up during their hospital length of stay, an average of 5 weeks
Discharge to home [%]
Time frame: Participants will be followed up during their hospital length of stay, an average of 5 weeks
Morbidity Scores
Time frame: Participants will be followed up during their intensive care unit stay, an average of 25 days
Amount of administered drugs
Time frame: Participants will be followed up to 6 days during their intensive care unit stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD Prof. study director
Charité - Univeritätsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pain, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2015.