An observational study in Intubated Brain Injured, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2018-12-05.
Sponsored by University Hospital, Montpellier · Observational
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).
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).
University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Admission to intensive care unit
Exclusion criteria:
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).
Difference in pain scores or pupillary diameter measures at rest and during care procedures
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.
Time frame: Through study completion (30 months)
Weight kappa coefficient for pain using the NCS-I
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).
Time frame: Through study completion (30 months)
Weight kappa coefficient for pain using the BPS
Weighted kappa coefficient will be used to measure inter-observers agreement using the two subjective pain scales (NCS-I and BPS).
Time frame: Through study completion (30 months)
Plan to share: Undecided
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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University Hospital, Montpellier