An interventional study of Pupillometer in Pain, sponsored by Basque Health Service. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-11.
Sponsored by Basque Health Service · Not applicable, Interventional, and Other
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 82 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Basque Health Service is the lead sponsor of 57 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Measurements of pupillary dilatation with pupillometer to administer or not analgesia
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)
Time frame: 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).
Time frame: An average of 1 year
Started Mar 2019 (actual). Primary completion is estimated for Jul 2022, 40 months after the start.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 40 months is above that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Basque Health Service