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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Critical Illness
• Intervention / Treatment: Device: Pupillometry

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.

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Ambre Sauvage; Phone Number: +33 247474747; Email: asauvage.isp@gmail.com
• Study Contact Backup: Name: Sophie JACQUIER, MD; Email: s.jacquier@chu-tours.fr

Study Locations

• France
  • Orléans, France, 45000
    • Recruiting
    • CHRU d'Orléans
    • Contact: Mai-Anh Nay, MD; Phone Number: +33238514444; Email: mai-anh.nay@chr-orleans.fr
  • Tours, France, 37000
    • Recruiting
    • CHRU de Tours
    • Contact: Sophie Jacquier, MD; Phone Number: +33247474747; Email: s.jacquier@chu-tours.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted in ICU, sedated, intubated, unable to communicate their levels of pain and requiring the placement of a deep venous catheter

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Amines; 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; Measurement of pain levels by pupillometry during the insertion of a deep venous catheter
Curares; 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; Measurement of pain levels by pupillometry during the insertion of a deep venous catheter
Sedation alone; 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; Measurement of pain levels by pupillometry during the insertion of a deep venous catheter

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Universitaire de Tours
• Collaborators: Centre Hospitalier Régional d'Orléans

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: June 22, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Pupillometry
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: DR230092; 2023-A00712-43 (Other Identifier: IdRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No