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PainNCT04078113

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

A study testing Pupillometer in people with Pain, run by Basque Health Service at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain
What is being tested?
Pupillometer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteSpain
Study dates
14 Mar 2019to 31 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Araba University hospital

    Vitoria-Gasteiz, Álava, 01009

Other trials in Spain

About this study

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

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
Being tested
Pupillometer
Keywords
Pupillary dilation, Analgosedated, Mechanically ventilation
Medical subject headings
Pain, Mydriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PupillometerOther

    Measurements of pupillary dilatation with pupillometer to administer or not analgesia

Study groups in NCT04078113
Study groupRoleWhat they receive
Experimental groupExperimentalEvery 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.
Receives: Other: Pupillometer
Control groupNo interventionBefore 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: An average of 1 year

  2. 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).

    Measured: An average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2019
  2. Study start14 Mar 2019
  3. Primary completion30 Jul 2022 (estimated)
  4. Study completion31 Oct 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
82 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04078113
Sponsor's protocol ID
PUPIPAIN
Status last verified
Mar 2022
First submitted
2 Jul 2019
Last updated
11 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 41159095

  • Lopez-de-Audicana-Jimenez-de-Aberasturi Y, Vallejo-De-la-Cueva A, Bermudez-Ampudia C, Perez-Francisco I, Bengoetxea-Ibarrondo MB, Parraza-Diez N. The comparison of pupillometry to standard clinical practice for pain and preemptive analgesia before endotracheal suctioning: A randomized controlled trial. Intensive Crit Care Nurs. 2025 Jun;88:103975. doi: 10.1016/j.iccn.2025.103975. Epub 2025 Feb 25.

    PubMed 40010039

  • 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.

    PubMed 39571502

  • 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.

    PubMed 37573155

Questions about this trial

What is this clinical trial studying?

A study testing Pupillometer in people with Pain, run by Basque Health Service at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Propotion of patient with pain on experimental group versus control group (time frame: An average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04078113, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.

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