Clinical trial NCT04078113: Stimulation and Validation of the Pupillary Dilation for the Detection of Pain in Analgosedated Patients Under Mechanically Ventilation in Intensive Care Unit
Official title: Stimulation Anda Validation of the Pupillary Dilation for the Detection of Pain in Analgosedated Patients Under Mechanically in Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Pupillary dilation
Analgosedated
Mechanically ventilation
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2019-09-04
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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) 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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Propotion of patient with pain on experimental group versus control group
timeFrame: An average of 1 year
measure: Proportion of patient who require anesthesia on experimental group versus control group
timeFrame: An average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Vitoria-Gasteiz
country: Spain
facility: Araba University hospital
state: Álava
Study officials:
affiliation: Basque Health System
name: Ana Vallejo de la Cueva, Dr.
role: PRINCIPAL_INVESTIGATOR
References: