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

Intubated Brain Injured Clinical Trial

— D co réa  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02830256
• Other study ID #: 9673
• Secondary ID: 2016-A00748-43
• Status: Completed
• Start date: November 3, 2016
• Est. completion date: November 28, 2017

Study information

• Verified date: April 2017
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 28, 2017
• Est. primary completion date: November 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Intubated Brain Injured

Intervention

Other:
• NCS-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).

Locations

Country	Name	City	State
France	UHMontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through study completion (30 months)
Secondary	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).	Through study completion (30 months)
Secondary	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).	Through study completion (30 months)