Pupillometry and Nociception Level Index for the Evaluation of Pain in Intensive Care Unit.

Critical Illness Clinical Trial

— NOCI-ICU  

Official title:

Pupillometry and Nociception Level Index (NOL-index) for the Evaluation of Pain in Intensive Care Unit. Prospective Study in Two Centers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05469841
• Other study ID #: CHRO-2022-04
• Status: Completed
• Phase: N/A
• Start date: July 29, 2022
• Est. completion date: March 28, 2023

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pain is a frequent symptom in the intensive care unit (ICU). Critical ill patients are often intubated and sedated which makes self-evaluation of pain impossible.

Pupillary dilatation is a reflex directly related to stimuli such as pain, which can be measured by quantitative pupillometry.

Several studies in ICU showed a significant relationship between pupillary diameter variation and pain.

The nociception level index (NOL-index) is a recent noninvasive and continuous monitoring of pain essentially used in operating room.

The aim of this study is to evaluate the pupillometry and NOL index in critical ill patients in sedated patients under mechanical ventilation during the mobilization plus toilet (described in literature as not painful procedure) and tracheal suctioning (described as a painful procedure)

Description:

Pain will be evaluated via i) pupillometry with 3 successive measurements ii) Behaviour Pain Scale (BPS) and Critical Care Pain Observation Tool (CPOT) score evaluated by an investigator (physician) iii) evolution of physiological parameters (ie heart rate, blood pressure, respiratory rate) iv) Nociception level index (NOL-index).

The evaluation times will be 5 minutes before care procedures (mobilization plus toilet and tracheal suctioning), during the procedures (with the worst value recorded) and 5 minutes after the procedures.

The procedures are:

• A mobilization and toilet of the patient: a priori, not a very painful procedure. The pain will be evaluated every 5 minutes during the toilet.

• Tracheal suctioning: a procedure known to be painful. The painful will be evaluated just at the end of tracheal suctioning (once the tracheal suctioning catheter is removed from the endotracheal intubation).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 28, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• older than18 years old

• Under invasive mechanical ventilation

• Sedated with i) a Richmond Agitation Sedation Scale (RASS) : = -4 and <1, ii) being unable to evaluate their pain by a visual numeric scale

Exclusion Criteria:

• Ophthalmological diseases which could modify the pupillometric parameters

• Neurological diseases (damage of nerve III, intracranial hypertension, stroke)

• Admitted in ICU after resuscitated cardiac arrest

• Drugs that inhibit the effect of the sympathetic system (clonidine, dexmedetomidine)

• Patient under Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO)

• Patient treated by a neuromuscular blockade

• A do-not resuscitate order

• Major hemodynamic instability prohibiting planned care procedures

Related Conditions & MeSH terms

• Critical Illness

Intervention

Other:
• Systemic pain assessment
Pain will be evaluated via i) pupillometry with 3 successive measurements ii) Behaviour Pain Scale (BPS) and Critical Care Pain Observation Tool (CPOT) score evaluated by an investigator (physician) iii) evolution of physiological parameters (ie heart rate, blood pressure, respiratory rate) iv) Nociception Level Index (NOL) index.

Locations

Country	Name	City	State
France	Regional Hospital Center	Orléans
France	Universitary Hospital Center	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pupillary redilatation velocity after constriction light-induced	Area under the ROC curve (AUC) of pupillary re-dilation velocity measured before a potentially painful procedure to predict the occurrence of a BPS score = 5 during the procedure.	1 hour during procedure
Secondary	Nociception Level index	To evaluate the predictive value of the NOL-index measured before a potentially painful procedure to predict the intensity of the pain felt during the procedure.	1 hour during procedure
Secondary	Systolic and diastolic Blood pressure	Describe the variations of vital parameters	1 hour during procedure
Secondary	Heart rate	Describe the variations of vital parameters	1 hour during procedure
Secondary	Respiratory rate	Describe the variations of vital parameters	1 hour during procedure
Secondary	Behaviour Pain Scale	Compare variations of nociception parameters during mobilizations and during tracheal aspirations Behaviour Pain Scale Score from 3 (no pain) to 12 (maximum pain)	1 hour during procedure