NCT04078113

Stimulation and Validation of the Pupillary Dilation for the Detection of Pain in Analgosedated Patients Under Mechanically Ventilation in Intensive Care Unit

Stimulation Anda Validation of the Pupillary Dilation for the Detection of Pain in Analgosedated Patients Under Mechanically in Intensive Care Unit

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Basque Health Service · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This project has 2 phases. Phase 1: diagnostic test study, to evaluate the efficacy of the variation of pupillary size (PDR) to detect pain in ICU patients regarding to Behavioural Pain Scale (BPS) and ESCID (Conductual Scale Pain Index). Phase 2: controlled and aleatorized clinical trial to evaluate efficacy in PDR monitoring after painful assessed minimum stimulus with the best diagnostic efficiency on phase 1, as a need of analgesia indicator tool. The sample will be patients over 18 years, sedated and mechanically ventilated, with an initial BPS of 3, RASS between -1 and -4, not able not to communicate , with inform consent signed. Exclusion criteria will be: ophtalmologic pathology and administration of drugs interfering pupillary reflexes. Measurements before/during pain/non-pain situations, aspiration of secretions and calibrated intensity stimulus through the pupilometer Algiscan. The investigators will study association between pain according to BPS/ESCID and pupillary dilatation according to pupillometry and percentage of patients with pain and preanalgesia according to pupillometry and standard clinical practice.

Conditions

• Pain

Interventions

Type	Name	Description
OTHER	Pupillometer	Measurements of pupillary dilatation with pupillometer to administer or not analgesia

Timeline

• Start date: 2019-03-14
• Primary completion: 2022-07-30
• Completion: 2022-10-31
• First posted: 2019-09-04
• Last updated: 2022-03-11

Locations

1 site across 1 country: Spain