Critical Illness
Conditions
Keywords
pain, intensive care, sedated, ventilated, NOL ICU, pupillometry
Brief 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. 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).
Interventions
OTHERSystemic pain assessment
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.
Sponsors
Centre Hospitalier Régional d'Orléans
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pupillary redilatation velocity after constriction light-induced | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nociception Level index | 1 hour during procedure | 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. |
| Systolic and diastolic Blood pressure | 1 hour during procedure | Describe the variations of vital parameters |
| Heart rate | 1 hour during procedure | Describe the variations of vital parameters |
| Respiratory rate | 1 hour during procedure | Describe the variations of vital parameters |
| Behaviour Pain Scale | 1 hour during procedure | Compare variations of nociception parameters during mobilizations and during tracheal aspirations Behaviour Pain Scale Score from 3 (no pain) to 12 (maximum pain) |
Countries
France
Outcome results
None listed