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Completed

NCT Number: NCT02830256

Psychometric Measurements of Three Nociception Assessments Methods in Intubated Brain Injured Critical Care Patients

Nociception in intensive care unit is frequently evaluated with some tools such as BPS (Behavioral Pain scale) and NCS (Nociception coma scale). These scales were not validated in intubated and brain injured ICU patients. The investigators propose to validate the NCS adapted for intubated patients (NCS-I) in comparison with the recommended scale (BPS) and the Pupillary response (videopupillometry) to noxious stimulation (common procedure of care).

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Key information

Conditions

Intubated Brain Injured Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UHMontpellier

Montpellier, 34295, France

About this study

Nociception in intensive care unit is frequently evaluated with some tools such as BPS (Behavioral Pain scale) and NCS (Nociception coma scale). These scales were not validated in intubated and brain injured ICU patients. The investigators propose to validate the NCS adapted for intubated patients (NCS-I) in comparison with the recommended scale (BPS) and the Pupillary response (videopupillometry) to noxious stimulation (common procedure of care).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult, > or equal to 18-yr
  • Admission to intensive care unit
  • Brain injured and intubated patient
  • Signs of awakening after the interruption of sedation
  • Impossibility to self-report pain intensity

Exclusion criteria

  • Eye injuries (glaucoma, keratitis, conjunctivis, cataract)
  • Neurodegenerative attack
  • Brainstem damage
  • Pregnancy

Treatment and study plan

NCS-I (Nociception Coma Scale adapted intubated patients)

Other

Every included patient will be assessed by the 3 methods 3 times (before, during, after the procedure fo care) in 3 conditions. There will be 2 painful conditions usually performed in ICU (Nursing and bronchoaspiration) and a painless condition (RASS assessment).

Primary outcomes

  1. Difference in pain scores or pupillary diameter measures at rest and during care procedures

    Time frame: Through study completion (30 months)

    Discriminant validity between NCS-I, BPS and pupillary measurements will follow current recommended method for psychometric assessment of pain tools in critical care patients (Pain Agitation and Delirium Guidelines from the Society of Critical Care Medicine, Barr et al. Crit Care Med 2013). Mann-Whitney-Wilcoxon test will be used to compare values obtained at rest and during the procedures of care.

Secondary outcomes

  1. Weight kappa coefficient for pain using the NCS-I

    Time frame: Through study completion (30 months)

    Reliability of NCS-I and BPS will follow current recommended method for psychometric assessment of pain tools in critical care patients (Pain Agitation and Delirium Guidelines from the Society of Critical Care Medicine, Barr et al. Crit Care Med 2013).

  2. Weight kappa coefficient for pain using the BPS

    Time frame: Through study completion (30 months)

    Weighted kappa coefficient will be used to measure inter-observers agreement using the two subjective pain scales (NCS-I and BPS).

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: D co réa

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 12, 2016
Registry last updated
Dec 5, 2018

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

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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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