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

NCT05962996 | Recruiting

• 2 other identifiers: DR2300922023-A00712-43
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Critical Illness

Keywords

Pupillometry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Changes in pupillary reflex latency by quantitative pupillometry

  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

  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

  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

  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

  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)

Study Arms (3)

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

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

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

Interventions

Pupillometry DEVICE

Measurement of pain levels by pupillometry during the insertion of a deep venous catheter

Amines; Curares; Sedation alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional Universitaire de Tours: lead
• Centre Hospitalier Régional d'Orléans: collaborator

Study Sites (2)

CHRU d'Orléans

Orléans, 45000, France

RECRUITING

CHRU de Tours

Tours, 37000, France

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ambre Sauvage

CONTACT

247474747; asauvage.isp@gmail.com

Sophie Jacquier, MD

CONTACT

S.JACQUIER@chu-tours.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 27, 2023
• Study Start: September 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

FR (2)