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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04078113
• Other study ID #: PUPIPAIN
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 14, 2019
• Est. completion date: October 31, 2022

Study information

• Verified date: March 2022
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 82
• Est. completion date: October 31, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mydriasis
• Pain

Intervention

Other:
• Pupillometer
Measurements of pupillary dilatation with pupillometer to administer or not analgesia

Locations

Country	Name	City	State
Spain	Araba University hospital	Vitoria-Gasteiz	Álava

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Propotion of patient with pain on experimental group versus control group	To compare the proprtion of patients with pain according to Behavioral Pain Scale (BPS), pupillometry and Scale of Behaviour Indicators of Pain (escid)	An average of 1 year
Primary	Proportion of patient who require anesthesia on experimental group versus control group	The proportion of patients who require anesthesia on experimental group (previous analgesia according to pupillometry during endotracheal aspiration) versus control group (previous analgesia according to standard clinical practice).	An average of 1 year