Clinical trial NCT05962996: Evaluation of Pain Levels by Quantitative Pupillometry During the Placement of Deep Venous Catheters in Sedated Patients in Intensive Care Unit (PUPICAT)
Official title: Evaluation of Pain Levels by Quantitative Pupillometry During the Placement of Deep Venous Catheters in Sedated Patients in Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critical Illness
Keywords: Pupillometry
Lead sponsor: Centre Hospitalier Régional Universitaire de Tours
Sponsor class: OTHER_GOV
Collaborators: name: Centre Hospitalier Régional d'Orléans
First posted: 2023-07-27
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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).

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.

Eligibility 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

Primary outcomes:
measure: Change in variation of pupillary diameter by quantitative pupillometry
timeFrame: 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:
measure: Changes in pupillary reflex latency by quantitative pupillometry
timeFrame: 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)
measure: Changes in pupil constriction by quantitative pupillometry
timeFrame: 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)
measure: Changes in pupil dilatation by quantitative pupillometry
timeFrame: 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)
measure: Changes in NPi by quantitative pupillometry
timeFrame: 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)
measure: Changes in BPS scores
timeFrame: 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)
measure: Changes in respiratory rate
timeFrame: 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)
measure: Changes in heart rate
timeFrame: 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)
measure: Changes in blood pressure
timeFrame: 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)
Other outcomes:
Locations:
city: Orléans
country: France
facility: CHRU d'Orléans
city: Tours
country: France
facility: CHRU de Tours
Study officials:
References: