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NCT Number: NCT05469841

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

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)

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Key information

Conditions

Critical Illness Disease Attributes Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regional Hospital Center, Orléans, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Systemic pain assessment

Other

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.

Primary outcomes

  1. pupillary redilatation velocity after constriction light-induced

    Time frame: 1 hour during procedure

    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.

Secondary outcomes

  1. Nociception Level index

    Time frame: 1 hour during procedure

    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.

  2. Systolic and diastolic Blood pressure

    Time frame: 1 hour during procedure

    Describe the variations of vital parameters

  3. Heart rate

    Time frame: 1 hour during procedure

    Describe the variations of vital parameters

  4. Respiratory rate

    Time frame: 1 hour during procedure

    Describe the variations of vital parameters

  5. Behaviour Pain Scale

    Time frame: 1 hour during procedure

    Compare variations of nociception parameters during mobilizations and during tracheal aspirations Behaviour Pain Scale Score from 3 (no pain) to 12 (maximum pain)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

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

Acronym: NOCI-ICU

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 22, 2022
Registry last updated
Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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