Back to resultsStimulation and Validation of the Pupillary Dilation for the Detection of Pain in Analgosedated Patients Under Mechanically Ventilation in Intensive Care Unit
Primary Purpose
Pain
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pupillometer
Sponsored by
About this trial
This is an interventional other trial for Pain focused on measuring Pupillary dilation, Analgosedated, Mechanically ventilation
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.
Sites / Locations
- Araba University hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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)
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04078113
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 14, 2019 (Actual)
Primary Completion Date
July 30, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Basque Health Service
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Pupillary dilation, Analgosedated, Mechanically ventilation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pupillometer
Intervention Description
Measurements of pupillary dilatation with pupillometer to administer or not analgesia
Primary Outcome Measure Information:
Title
Propotion of patient with pain on experimental group versus control group
Description
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
Title
Proportion of patient who require anesthesia on experimental group versus control group
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Vallejo de la Cueva, Dr.
Organizational Affiliation
Basque Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Araba University hospital
City
Vitoria-Gasteiz
State/Province
Álava
ZIP/Postal Code
01009
Country
Spain
12. IPD Sharing Statement
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Stimulation and Validation of the Pupillary Dilation for the Detection of Pain in Analgosedated Patients Under Mechanically Ventilation in Intensive Care Unit
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