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

NCT04078113 | Unknown

• 1 other identifier: PUPIPAIN
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Pupillary dilation; Analgosedated; Mechanically ventilation

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

Every patient will be subjected to a measured stimulus with a power selected in phase 1 (X mA) and pupillary dilatation will be measured by pupillometry. In those patients showing pupillary size variation over the limit for insufficient analgesia estimated in phase 1 for tracheal suction, additional analgesia will be provided before tracheal suction. In those patients without pain detected by pupillometry, additional anlagesia won´t be provided. In both cases Pupillometry, BPS and ESCID will be measured during tracheal suction to determine whether the patient is in pain or not.

Other: Pupillometer

Control group

NO INTERVENTION

Before tracheal suction and due to medical decision, analgesia following current clinical practice would be administered prophylactically. Pupillometry, BPS and ESCID will be measured during tracheal suction to determinate whether the patient is in pain or not.

Interventions

Pupillometer OTHER

Measurements of pupillary dilatation with pupillometer to administer or not analgesia

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Basque Health Service: lead

Study Sites (1)

Araba University hospital

Vitoria-Gasteiz, Álava, 01009, Spain

Location

Related Publications (3)

• Lopez de Audicana Jimenez de Aberasturi Y, Vallejo De la Cueva A, Parraza Diez N. The effectiveness of a pupillary dilation reflex as an analgesia indicator: A protocol for a randomised multicentre trial in critically ill patients. Int J Nurs Stud Adv. 2025 Oct 1;9:100431. doi: 10.1016/j.ijnsa.2025.100431. eCollection 2025 Dec.

  PMID: 41159095 DERIVED

• Lopez-De-Audicana-Jimenez-De-Aberasturi Y, Vallejo-De-La-Cueva A, Parraza-Diez N. Behavioral pain scales, vital signs, and pupilometry to pain assessment in the critically ill patient: A cross sectional study. Clin Neurol Neurosurg. 2024 Dec;247:108644. doi: 10.1016/j.clineuro.2024.108644. Epub 2024 Nov 18.

  PMID: 39571502 DERIVED

• Lopez de Audicana-Jimenez de Aberasturi Y, Vallejo-De la Cueva A, Aretxabala-Cortajarena N, Rodriguez-Nunez C, Pelegrin-Gaspar PM, Gil-Garcia ZI, Rodriguez-Borrajo MJ, Marguello-Fernandez AA, Parraza-Diez N. The pupillary dilation reflex to a nociceptive stimulus as a tool for analgesia management: A diagnostic study. Aust Crit Care. 2024 Mar;37(2):230-235. doi: 10.1016/j.aucc.2023.06.009. Epub 2023 Aug 10.

  PMID: 37573155 DERIVED

MeSH Terms

Conditions

Pain; Mydriasis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pupil Disorders; Eye Diseases

Study Officials

• Ana Vallejo de la Cueva, Dr.

  Basque Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: September 4, 2019
• Study Start: March 14, 2019
• Primary Completion: July 30, 2022
• Study Completion: October 31, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-03

Locations

ES (1)