Evaluation of Pain Levels by Quantitative Pupillometry During the Placement of Deep Venous Catheters in Sedated Patients in Intensive Care Unit (PUPICAT)

Study Overview
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Brief Summary
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Pain is common in intensive care and gives rise to multiple consequences that can impact the future of patients. The placement of deep venous catheters are painful gestures of common practice in intensive care. However, some patients are ventilated and sedated and their level of pain is difficult to judge. Quantitative pupillometry seems to be a reliable tool for assessing pain in these patients unable to communicate. The method is already common practice in the operating room for this indication and recent studies increasingly validate its use in intensive care. The aim of the study is to validate the different levels of pain that can be assessed by pupillometry within this population during catheterization and to identify any non-responding subgroups (in order to conduct future clinical trials evaluating pain therapies).

Detailed Description
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Three groups of patients will be studied : with aminergic drugs / with curare / without aminergic drugs nor curare. The measurement of pain levels by quantitative pupillometry (NPi®-200 pupillometer, NeurOptics® USA) will be made in intubated, sedated patients, unable to communicate on their level of pain during the placement of a deep venous catheter. Pain will be evaluated before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter. Simultaneously, RASS and BPS scores as well as the patient's vital parameters and the cumulative doses of sedation-analgesia, curare and aminergic drugs will be collected.

Official Title
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Evaluation of Pain Levels by Quantitative Pupillometry During the Placement of Deep Venous Catheters in Sedated Patients in Intensive Care Unit

Conditions
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Critical Illness

Intervention / Treatment
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* Device: Pupillometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged over 18 hospitalized in Intensive Care Unit Requiring the placement of a deep venous catheter (central venous catheter or dialysis catheter) Sedated, intubated, unable to communicate about pain No opposition to participation in the study Exclusion Criteria: Any ophthalmological pathology (lesion of the orbital cavity, edematous soft tissue or with an open lesion) Any intracranial pathology (stroke, subarachnoid hemorrhage, tumour, etc.) Patient post-cardio-respiratory arrest within the first 48 hours Medicines interfering with the pupillary reflex: clonidine dexmedetomidine, droperidol, metoclopramide, nitric oxide, scopolamine, atropine Patient protected within the law Previous participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Amines<br>Sedated and intubated patients requiring a deep venous catheter, unable to communicate their level of pain, and treated with aminergic drugs (no curare) Assessment of pain levels by pupillometry during the placement of the deep venous catheter | Device: Pupillometry<br>* Measurement of pain levels by pupillometry during the insertion of a deep venous catheter<br>|
| Curares<br>Sedated and intubated patients requiring a deep venous catheter, unable to communicate their level of pain, and treated with curares (no aminergic drug) Assessment of pain levels by pupillometry during the placement of the deep venous catheter | Device: Pupillometry<br>* Measurement of pain levels by pupillometry during the insertion of a deep venous catheter<br>|
| Sedation alone<br>Sedated and intubated patients requiring a deep venous catheter, unable to communicate their level of pain, without any aminergic drug nor curare Assessment of pain levels by pupillometry during the placement of the deep venous catheter | Device: Pupillometry<br>* Measurement of pain levels by pupillometry during the insertion of a deep venous catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in variation of pupillary diameter by quantitative pupillometry | Pupillary variation (%) = [maximum pupil diameter (mm) - minimum pupil diameter (mm)] / maximum pupil diameter (mm)] | During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pupillary reflex latency by quantitative pupillometry | Latency of pupillary reflex in seconds | During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes) | 
| Changes in pupil constriction by quantitative pupillometry | Pupil constriction speed in mm/s | During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes) | 
| Changes in pupil dilatation by quantitative pupillometry | Pupil dilation speed in mm/s | During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes) | 
| Changes in NPi by quantitative pupillometry | Neurological Pupil Index (NPi), from 0 to 4.9, higher scores meaning a better outcome (normal pupillary light reflex) | During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes) | 
| Changes in BPS scores | Behavioural Pain Scale scores : from 3 to 12, higher scores meaning a worse outcome (more pain) | During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes) | 
| Changes in respiratory rate | Respiratory rate (cycles per minute) | During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes) | 
| Changes in heart rate | Heart rate (beats per minute) | During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes) | 
| Changes in blood pressure | Blood pressure (mmHg) | During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pupillometry