Critical IllnessNOCI-ICUNCT05469841
Pupillometry and Nociception Level Index for the Evaluation of Pain in Intensive Care Unit.
A study testing Systemic pain assessment in people with Critical Illness, run by Centre Hospitalier Régional d'Orléans at 2 sites in France.
Trial summary
Pain is a frequent symptom in the intensive care unit (ICU). Critical ill patients are often intubated and sedated which makes self-evaluation of pain impossible. Pupillary dilatation is a reflex directly related to stimuli such as pain, which can be measured by quantitative pupillometry. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- Systemic pain assessment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- 29 Jul 2022to 28 Mar 2023
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- older than18 years old
- Under invasive mechanical ventilation
- Sedated with i) a Richmond Agitation Sedation Scale (RASS) : ≥ -4 and <1, ii) being unable to evaluate their pain by a visual numeric scale
Who cannot join
- Ophthalmological diseases which could modify the pupillometric parameters
- Neurological diseases (damage of nerve III, intracranial hypertension, stroke)
- Admitted in ICU after resuscitated cardiac arrest
- Drugs that inhibit the effect of the sympathetic system (clonidine, dexmedetomidine)
- Patient under Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO)
- Patient treated by a neuromuscular blockade
- A do-not resuscitate order
- Major hemodynamic instability prohibiting planned care procedures
Trial locations and contacts
2 sites in 1 country.
France2 sites
Regional Hospital Center
Orléans, 45067
Universitary Hospital Center
Tours, 37000
About this study
Official title: Pupillometry and Nociception Level Index (NOL-index) for the Evaluation of Pain in Intensive Care Unit. Prospective Study in Two Centers
Pain is a frequent symptom in the intensive care unit (ICU). Critical ill patients are often intubated and sedated which makes self-evaluation of pain impossible.
Pupillary dilatation is a reflex directly related to stimuli such as pain, which can be measured by quantitative pupillometry.
Read more
Several studies in ICU showed a significant relationship between pupillary diameter variation and pain.
The nociception level index (NOL-index) is a recent noninvasive and continuous monitoring of pain essentially used in operating room.
The aim of this study is to evaluate the pupillometry and NOL index in critical ill patients in sedated patients under mechanical ventilation during the mobilization plus toilet (described in literature as not painful procedure) and tracheal suctioning (described as a painful procedure)
Read the detailed description
Pain will be evaluated via i) pupillometry with 3 successive measurements ii) Behaviour Pain Scale (BPS) and Critical Care Pain Observation Tool (CPOT) score evaluated by an investigator (physician) iii) evolution of physiological parameters (ie heart rate, blood pressure, respiratory rate) iv) Nociception level index (NOL-index).
The evaluation times will be 5 minutes before care procedures (mobilization plus toilet and tracheal suctioning), during the procedures (with the worst value recorded) and 5 minutes after the procedures.
The procedures are:
- A mobilization and toilet of the patient: a priori, not a very painful procedure. The pain will be evaluated every 5 minutes during the toilet.
- Tracheal suctioning: a procedure known to be painful. The painful will be evaluated just at the end of tracheal suctioning (once the tracheal suctioning catheter is removed from the endotracheal intubation).
- Conditions
- Critical Illness
- Being tested
- Systemic pain assessment
- Keywords
- pain, intensive care, sedated, ventilated, NOL ICU, pupillometry
- Medical subject headings
- Critical Illness, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic pain assessmentOther
Pain will be evaluated via i) pupillometry with 3 successive measurements ii) Behaviour Pain Scale (BPS) and Critical Care Pain Observation Tool (CPOT) score evaluated by an investigator (physician) iii) evolution of physiological parameters (ie heart rate, blood pressure, respiratory rate) iv) Nociception Level Index (NOL) index.
| Study group | Role | What they receive |
|---|---|---|
| Pupillometry | Experimental | Pain will be evaluated via pupillometry with 3 successive measurements Receives: Other: Systemic pain assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
pupillary redilatation velocity after constriction light-induced
Area under the ROC curve (AUC) of pupillary re-dilation velocity measured before a potentially painful procedure to predict the occurrence of a BPS score ≥ 5 during the procedure.
Measured: 1 hour during procedure
Secondary outcomes (5)
Nociception Level index
To evaluate the predictive value of the NOL-index measured before a potentially painful procedure to predict the intensity of the pain felt during the procedure.
Measured: 1 hour during procedure
Systolic and diastolic Blood pressure
Describe the variations of vital parameters
Measured: 1 hour during procedure
Heart rate
Describe the variations of vital parameters
Measured: 1 hour during procedure
Respiratory rate
Describe the variations of vital parameters
Measured: 1 hour during procedure
Behaviour Pain Scale
Compare variations of nociception parameters during mobilizations and during tracheal aspirations Behaviour Pain Scale Score from 3 (no pain) to 12 (maximum pain)
Measured: 1 hour during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start29 Jul 2022
- Primary completion28 Mar 2023
- Study completion28 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mai Anh NAY, MD, Study director, Regional Hospital Center of ORLEANS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469841
- Sponsor's protocol ID
- CHRO-2022-04
- Acronym
- NOCI-ICU
- Status last verified
- Mar 2023
- First submitted
- 20 Jun 2022
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pupillometry and Nociception Level Index (NOL-index) for the Evaluation of Pain in Intensive Care Unit. Prospective Study in Two Centers
- ClinicalTrials.gov ID
- NCT05469841
- Acronym / sponsor ID
- NOCI-ICU / CHRO-2022-04
- Conditions
- Critical Illness
- Keywords
- pain, intensive care, sedated, ventilated, NOL ICU, pupillometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 22 Jul 2022 (actual)
- 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.
Pain is a frequent symptom in the intensive care unit (ICU). Critical ill patients are often intubated and sedated which makes self-evaluation of pain impossible.
Pupillary dilatation is a reflex directly related to stimuli such as pain, which can be measured by quantitative pupillometry.
Several studies in ICU showed a significant relationship between pupillary diameter variation and pain.
The nociception level index (NOL-index) is a recent noninvasive and continuous monitoring of pain essentially used in operating room.
The aim of this study is to evaluate the pupillometry and NOL index in critical ill patients in sedated patients under mechanical ventilation during the mobilization plus toilet (described in literature as not painful procedure) and tracheal suctioning (described as a painful procedure)
Detailed description
Pain will be evaluated via i) pupillometry with 3 successive measurements ii) Behaviour Pain Scale (BPS) and Critical Care Pain Observation Tool (CPOT) score evaluated by an investigator (physician) iii) evolution of physiological parameters (ie heart rate, blood pressure, respiratory rate) iv) Nociception level index (NOL-index).
The evaluation times will be 5 minutes before care procedures (mobilization plus toilet and tracheal suctioning), during the procedures (with the worst value recorded) and 5 minutes after the procedures.
The procedures are:
- A mobilization and toilet of the patient: a priori, not a very painful procedure. The pain will be evaluated every 5 minutes during the toilet.
- Tracheal suctioning: a procedure known to be painful. The painful will be evaluated just at the end of tracheal suctioning (once the tracheal suctioning catheter is removed from the endotracheal intubation).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pupillometry | Experimental | Other: Systemic pain assessmentPain will be evaluated via pupillometry with 3 successive measurements |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- older than18 years old
- Under invasive mechanical ventilation
- Sedated with i) a Richmond Agitation Sedation Scale (RASS) : ≥ -4 and <1, ii) being unable to evaluate their pain by a visual numeric scale
Key exclusion criteria (8 listed)
- Ophthalmological diseases which could modify the pupillometric parameters
- Neurological diseases (damage of nerve III, intracranial hypertension, stroke)
- Admitted in ICU after resuscitated cardiac arrest
- Drugs that inhibit the effect of the sympathetic system (clonidine, dexmedetomidine)
- Patient under Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systemic pain assessmentPain will be evaluated via i) pupillometry with 3 successive measurements ii) Behaviour Pain Scale (BPS) and Critical Care Pain Observation Tool (CPOT) score evaluated by an investigator (physician) iii) evolution of physiological parameters (ie heart rate, blood pressure, respiratory rate) iv) Nociception Level Index (NOL) index. | Other | Pupillometry |
Primary outcome
pupillary redilatation velocity after constriction light-induced
Time frame: 1 hour during procedure
Area under the ROC curve (AUC) of pupillary re-dilation velocity measured before a potentially painful procedure to predict the occurrence of a BPS score ≥ 5 during the procedure.
5 secondary outcomes
Nociception Level index
Time frame: 1 hour during procedure
Systolic and diastolic Blood pressure
Time frame: 1 hour during procedure
Heart rate
Time frame: 1 hour during procedure
Respiratory rate
Time frame: 1 hour during procedure
Behaviour Pain Scale
Time frame: 1 hour during procedure
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 3 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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.
Mai Anh NAY, MD study director
Regional Hospital Center of ORLEANS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systemic pain assessment in people with Critical Illness, run by Centre Hospitalier Régional d'Orléans at 2 sites in France.
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 8 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 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
pupillary redilatation velocity after constriction light-induced (time frame: 1 hour during procedure). 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 3 Apr 2023.