Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02830256
Acronym
D co réa
Enrollment
50
Registered
2016-07-12
Start date
2016-11-03
Completion date
2017-11-28
Last updated
2018-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubated Brain Injured

Keywords

Intensive care unit, Neuro-ICU, Pain, Intubation, critical care, patients

Brief summary

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).

Detailed description

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).

Interventions

OTHERNCS-I (Nociception Coma Scale adapted intubated patients)

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).

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Difference in pain scores or pupillary diameter measures at rest and during care proceduresThrough 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

MeasureTime frameDescription
Weight kappa coefficient for pain using the NCS-IThrough 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).
Weight kappa coefficient for pain using the BPSThrough 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).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026