Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A00712-43 | Other Identifier | IdRCB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centre Hospitalier Régional d'Orléans | OTHER |
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pupillometry | Device | Measurement of pain levels by pupillometry during the insertion of a deep venous catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients admitted in ICU, sedated, intubated, unable to communicate their levels of pain and requiring the placement of a deep venous catheter
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ambre Sauvage | Contact | 247474747 | +33 | asauvage.isp@gmail.com |
| Sophie Jacquier, MD | Contact | S.JACQUIER@chu-tours.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU d'Orléans | Recruiting | Orléans | 45000 | France |
Not provided
Not provided
Not provided
Not provided
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| CHRU de Tours | Recruiting | Tours | 37000 | France |
|
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided