Status:
UNKNOWN
Stimulation and Validation of the Pupillary Dilation for the Detection of Pain in Analgosedated Patients Under Mechanically Ventilation in Intensive Care Unit
Lead Sponsor:
Basque Health Service
Conditions:
Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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) an...
Eligibility Criteria
Inclusion
- Patients over 18 years.
- Analgosedated patients under mechanical ventilation.
- Unable to communicate (verbal or motor).
- Patients with initial BPS of 3, and RASS from -1 to -4.
- Familiar prior informed consent.
Exclusion
- Patients treated with muscle relaxants.
- Severe Critical Polyneuropathy.
- Pupillary reflex affectation in diabetic patients (diabetic papillopathy,glaucomatous optic neuropathy) or any other pathologies like Adie´s Syndrome, Argyl-Robertson pupil.
- Patients with tansmisible ocular infections.
- Patients with possible injury of the third carnial nerve (Horner´s syndrome) due to injury to the brainstem, cervical cord, cancer of the upper lobe the lung, dissection of the carotid and/or cluster headache.
- Acute cerbrovascular conditions with Glasgow Coma Scale less than 6, or increased intracranial pressure, or pontine base infarction.
- Drugs that interfere with the pupillary reflex (clonidine, dexmedetomidine, metoclopramide, tramadol, droperidol, ketamine, nitrous oxide).
- Patients under metoclopramide, if given 10 minutes prior the measurement of the pupillary reflex (PDR).
- Patients during the first 24 hours after Cardiac Arrest (CRP).
- Severe unestable comorbidity with doses of norepinephrine\> 0.6 microg/kg/min and/or dobutamine\>10 microg/kg/min or drenalin any doses.
- Patients with untreated pheochromocytomas.
- Refuse to participate in the trial.
Key Trial Info
Start Date :
March 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2022
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04078113
Start Date
March 14 2019
End Date
October 31 2022
Last Update
March 11 2022
Active Locations (1)
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1
Araba University hospital
Vitoria-Gasteiz, Álava, Spain, 01009