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

Centre Hospitalier Régional Universitaire de Tours90 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Critical Illness

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in variation of pupillary diameter by quantitative pupillometry

Pupillary variation (%) = \[maximum pupil diameter (mm) - minimum pupil diameter (mm)\] / maximum pupil diameter (mm)\]

Time frame: 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 Outcomes

Changes in pupillary reflex latency by quantitative pupillometry

Latency of pupillary reflex in seconds

Changes in pupil constriction by quantitative pupillometry

Pupil constriction speed in mm/s

Changes in pupil dilatation by quantitative pupillometry

Pupil dilation speed in mm/s

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)

Changes in BPS scores

Behavioural Pain Scale scores : from 3 to 12, higher scores meaning a worse outcome (more pain)

Changes in respiratory rate

Respiratory rate (cycles per minute)

Changes in heart rate

Heart rate (beats per minute)

Changes in blood pressure

Blood pressure (mmHg)