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 Tours

Status: Enrolling

Conditions: Critical Illness

Treatments: Device: Pupillometry

Study type: Observational

Funder types: Other

Identifiers

NCT05962996

DR230092

2023-A00712-43 (Other Identifier)

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

90 participants in 3 patient groups

Amines

Description:

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

Treatment:

Device: Pupillometry

Curares

Description:

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

Treatment:

Device: Pupillometry

Sedation alone

Description:

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

Treatment:

Device: Pupillometry