NCT05962996

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: Centre Hospitalier Régional Universitaire de Tours · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Critical Illness

Interventions

Type	Name	Description
DEVICE	Pupillometry	Measurement of pain levels by pupillometry during the insertion of a deep venous catheter

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2023-07-27
• Last updated: 2024-02-07

Locations

2 sites across 1 country: France