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

Critical Illness Clinical Trial

— PUPICAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05962996
• Other study ID #: DR230092
• Secondary ID: 2023-A00712-43
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Régional Universitaire de Tours
• Contact: Ambre Sauvage
• Phone: 247474747
• Email: asauvage.isp[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

Device:
• Pupillometry
Measurement of pain levels by pupillometry during the insertion of a deep venous catheter

Locations

Country	Name	City	State
France	CHRU d'Orléans	Orléans
France	CHRU de Tours	Tours

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Universitaire de Tours	Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)