Critical IllnessPUPICATNCT05962996
Evaluation of Pain Levels by Quantitative Pupillometry During the Placement of Deep Venous Catheters in Sedated Patients in Intensive Care Unit (PUPICAT)
An observational study of Critical Illness, run by Centre Hospitalier Régional Universitaire de Tours at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Pupillometry
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Sep 2023to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted in ICU, sedated, intubated, unable to communicate their levels of pain and requiring the placement of a deep venous catheter
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Sophie Jacquier, MD contact
France2 sites, 2 recruiting
- Recruiting
CHRU d'Orléans
Orléans, 45000
Mai-Anh Nay, MD, +33238514444, mai-anh.nay@chr-orleans.fr
- Recruiting
CHRU de Tours
Tours, 37000
Sophie Jacquier, MD, +33247474747, s.jacquier@chu-tours.fr
About this study
Official title: Evaluation of Pain Levels by Quantitative Pupillometry During the Placement of Deep Venous Catheters in Sedated Patients in Intensive Care Unit
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).
Read the 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.
- Conditions
- Critical Illness
- Being tested
- Pupillometry
- Keywords
- Pupillometry
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PupillometryDevice
Measurement of pain levels by pupillometry during the insertion of a deep venous catheter
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Device: Pupillometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in variation of pupillary diameter by quantitative pupillometry
Pupillary variation (%) = [maximum pupil diameter (mm) - minimum pupil diameter (mm)] / maximum pupil diameter (mm)]
Measured: 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
Latency of pupillary reflex in seconds
Measured: 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
Pupil constriction speed in mm/s
Measured: 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
Pupil dilation speed in mm/s
Measured: 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
Neurological Pupil Index (NPi), from 0 to 4.9, higher scores meaning a better outcome (normal pupillary light reflex)
Measured: 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
Behavioural Pain Scale scores : from 3 to 12, higher scores meaning a worse outcome (more pain)
Measured: 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 respiratory rate
Respiratory rate (cycles per minute)
Measured: 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 heart rate
Heart rate (beats per minute)
Measured: 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 blood pressure
Blood pressure (mmHg)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Sep 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Universitaire de Tours
- Sponsor type
- Other government
- Collaborators
- Centre Hospitalier Régional d'Orléans
- Responsible party
- Principal investigator, Ambre Sauvage, Centre Hospitalier Régional Universitaire de Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962996
- Sponsor's protocol ID
- DR230092
- Other IDs
- 2023-A00712-43
- Acronym
- PUPICAT
- Status last verified
- Feb 2024
- First submitted
- 22 Jun 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pain Levels by Quantitative Pupillometry During the Placement of Deep Venous Catheters in Sedated Patients in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05962996
- Acronym / sponsor ID
- PUPICAT / DR230092
- Conditions
- Critical Illness
- Keywords
- Pupillometry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional Universitaire de ToursOther government
- Collaborators
- Centre Hospitalier Régional d'Orléans
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amines | – | Device: PupillometrySedated 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 |
| Curares | – | Device: PupillometrySedated 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 |
| Sedation alone | – | Device: PupillometrySedated 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted in ICU, sedated, intubated, unable to communicate their levels of pain and requiring the placement of a deep venous catheter
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PupillometryMeasurement of pain levels by pupillometry during the insertion of a deep venous catheter | Device | Amines, Curares, Sedation alone |
Primary outcome
Change in variation of pupillary diameter by quantitative pupillometry
Time frame: 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)
Pupillary variation (%) = [maximum pupil diameter (mm) - minimum pupil diameter (mm)] / maximum pupil diameter (mm)]
8 secondary outcomes
Changes in pupillary reflex latency by quantitative pupillometry
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 respiratory rate
Time frame: 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 heart rate
Time frame: 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 blood pressure
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Jacquier, MD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Centre Hospitalier Régional Universitaire de Tours at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ambre Sauvage (247474747 ext. +33, asauvage.isp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in variation of pupillary diameter by quantitative pupillometry (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.