Evaluation of Pain Levels by Quantitative Pupillometry During the Placement of Deep Venous Catheters in Sedated Patients in Intensive Care Unit (PUPICAT)
NCT ID: NCT05962996
Last Updated: 2024-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
90 participants
OBSERVATIONAL
2023-09-01
2024-08-01
Brief Summary
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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).
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Detailed Description
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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
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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
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
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
Pupillometry
Measurement of pain levels by pupillometry during the insertion of a deep venous catheter
Interventions
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Pupillometry
Measurement of pain levels by pupillometry during the insertion of a deep venous catheter
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Centre Hospitalier Régional d'Orléans
OTHER
Centre Hospitalier Régional Universitaire de Tours
OTHER_GOV
Responsible Party
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Ambre Sauvage
Principal Investigator
Locations
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CHRU d'Orléans
Orléans, , France
CHRU de Tours
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-A00712-43
Identifier Type: OTHER
Identifier Source: secondary_id
DR230092
Identifier Type: -
Identifier Source: org_study_id
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