Evaluating pain levels during deep venous catheter placement in sedated ICU patients
Evaluation of Pain Levels by Quantitative Pupillometry During the Placement of Deep Venous Catheters in Sedated Patients in Intensive Care Unit
Centre Hospitalier Régional Universitaire de Tours · NCT05962996
This study is testing how much pain sedated ICU patients feel during the placement of deep venous catheters to see if a new method using pupil size can help measure their pain levels.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Régional Universitaire de Tours (other gov) |
| Locations | 2 sites (Orléans and 1 other locations) |
| Trial ID | NCT05962996 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess pain levels in sedated, intubated patients in the intensive care unit (ICU) during the placement of deep venous catheters using quantitative pupillometry. The study will involve three groups of patients based on their medication status: those receiving aminergic drugs, those receiving curare, and those receiving neither. Pain assessments will be conducted at various stages of the catheter placement process, and additional data on sedation and vital parameters will be collected. The goal is to validate pupillometry as a reliable pain assessment tool in this population and identify any subgroups that do not respond to pain stimuli.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old, hospitalized in the ICU, requiring deep venous catheter placement, and unable to communicate their pain due to sedation.
Not a fit: Patients with ophthalmological or intracranial pathologies, or those on medications that interfere with the pupillary reflex, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve pain management strategies for sedated ICU patients undergoing invasive procedures.
How similar studies have performed: Previous studies have shown promising results using pupillometry for pain assessment in similar settings, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Orléans and 1 other locations
- CHRU d'Orléans — Orléans, France (RECRUITING)
- CHRU de Tours — Tours, France (RECRUITING)
Study contacts
- Study coordinator: Ambre Sauvage
- Email: asauvage.isp@gmail.com
- Phone: 247474747
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Critical Illness, Pupillometry