Intubation ComplicationNCT05633069
Interest of Instantaneous Fluctuations of Pupillary Diameter for Pain Evaluation in Intensive Care Sedated Patients.
An observational study of Intubation Complication, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
New pain assessment parameter, called the Variation Coefficient of Pupillary Diameter (VCPD) described. This parameter allows evaluating the pain of patients during uterine contractions in obstetrical labor, and postoperatively in recovery room. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation Complication
- What is being tested?
- Datas analysed by medical records
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2022to 30 Nov 2022
- Phase
- Observational
- 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
Study population: Patients hospitalized in the surgical Intensive Care Unit (ICU) of the University Hospital of Saint-Etienne between September 2015 and August 2016 for medical-surgical pathologies, requiring orotracheal intubation or tracheostomy, and presenting on the day of recording a Riker sedation score of 3 or 4 will be included.
Who may be able to join
- hospitalized in the surgical Intensive Care Unit (ICU) of the University Hospital of Saint-Etienne between September 2015 and August 2016 for medical-surgical pathologies
- requiring orotracheal intubation or tracheostomy
- and presenting a Riker sedation score of 3 or 4.
Who cannot join
- cerebral palsy
- curarization
- paraplegia or tetraplegia
- intensive care neuromyopathy
- ocular pathology
- history of severe dysautonomic disease that could influence the evaluation of the Behavioral Pain Scale (BPS) or Variation Coefficient of Pupillary Diameter (VCPD) score
- receiving antiarrhythmic treatment that could make the interpretation of the results difficult
- on metoclopramide, droperidol, clonidine, or dexmedetomidine, which are known to alter the pupil dilation reflex.
Trial locations and contacts
1 site in 1 country.
About this study
New pain assessment parameter, called the Variation Coefficient of Pupillary Diameter (VCPD) described. This parameter allows evaluating the pain of patients during uterine contractions in obstetrical labor, and postoperatively in recovery room.
This parameter also allows evaluating the level of pain in Intensive Care Unit (ICU), in intubated or tracheotomized patients moderately sedated (Riker score 3 or 4).
Read the detailed description
This study propose to recalculate the Variation Coefficient of Pupillary Diameter (VCPD) from pupil recordings performed in the Intensive Care Unit (ICU) in 2015-2016 and kept in the patients' records. From there, the Variation Coefficient of Pupillary Diameter (VCPD) will compare to the Behavioral Pain Scale (BPS), considered the gold standard pain assessment
- Conditions
- Intubation Complication
- Being tested
- Datas analysed by medical records
- Keywords
- Fluctuation of pupillary diameter, Variation coefficient of pupillary diameter, Pain monitoring, Behavioral Pain Scale, Videopupillometer, Intensive Care Unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Datas analysed by medical recordsOther
Datas analysed by medical records : pupillary parameters: pupillary diameter and pupillary diameter variation. heart rate, the blood pressure, the Behavioral Pain Scale (BPS) pain score before and during painful procedures.
The pupillary parameters were recorded with the AlgiScan® pupillometer (iDMed, Marseille, France), which allows the recording of Pupillary Diameter (PD) variations at the patient's bed at a sampling frequency of 67 hertz.
| Study group | Role | What they receive |
|---|---|---|
| Patients requiring orotracheal intubation or tracheostomy | Patients hospitalized in the surgical Intensive Care Unit (ICU) of the University Hospital of Saint-Etienne between September 2015 and August 2016 for medical-surgical pathologies, requiring orotracheal intubation or tracheostomy, and presenting on the day of recording a Riker sedation score of 3 or 4 will be included.
Datas analysed by medical records. Receives: Other: Datas analysed by medical records |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between fluctuations in Pupillary Diameter (PD), as assessed by the Variation Coefficient of Pupillary Diameter (VCPD) and the level of pain.
Variation Coefficient of Pupillary Diameter (VCPD) calculate from continuous pupil recordings during tracheal aspirations, considered as a painful procedure.
The nurse in charge of the patient scored the Riker sedation score before endotracheal suctioning and the pain level estimated by the Behavioral Pain Scale (BPS) scale before and during endotracheal suctioning.
Measured: Months: 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start1 Nov 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David CHARIER, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633069
- Sponsor's protocol ID
- IRBN412014/CHUSTE
- Status last verified
- Dec 2022
- First submitted
- 21 Nov 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Instantaneous Fluctuations of Pupillary Diameter for Pain Evaluation in Intensive Care Sedated Patients.
- ClinicalTrials.gov ID
- NCT05633069
- Acronym / sponsor ID
- IRBN412014/CHUSTE
- Conditions
- Intubation Complication
- Keywords
- Fluctuation of pupillary diameter, Variation coefficient of pupillary diameter, Pain monitoring, Behavioral Pain Scale, Videopupillometer, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
New pain assessment parameter, called the Variation Coefficient of Pupillary Diameter (VCPD) described. This parameter allows evaluating the pain of patients during uterine contractions in obstetrical labor, and postoperatively in recovery room.
This parameter also allows evaluating the level of pain in Intensive Care Unit (ICU), in intubated or tracheotomized patients moderately sedated (Riker score 3 or 4).
Detailed description
This study propose to recalculate the Variation Coefficient of Pupillary Diameter (VCPD) from pupil recordings performed in the Intensive Care Unit (ICU) in 2015-2016 and kept in the patients' records. From there, the Variation Coefficient of Pupillary Diameter (VCPD) will compare to the Behavioral Pain Scale (BPS), considered the gold standard pain assessment
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients requiring orotracheal intubation or tracheostomy | – | Other: Datas analysed by medical recordsPatients hospitalized in the surgical Intensive Care Unit (ICU) of the University Hospital of Saint-Etienne between September 2015 and August 2016 for medical-surgical pathologies, requiring orotracheal intubation or tracheostomy, and presenting on the day of recording a Riker sedation score of 3 or 4 will be included. Datas analysed by medical records. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in the surgical Intensive Care Unit (ICU) of the University Hospital of Saint-Etienne between September 2015 and August 2016 for medical-surgical pathologies, requiring orotracheal intubation or tracheostomy, and presenting on the day of recording a Riker sedation score of 3 or 4 will be included.
Key inclusion criteria (3 listed)
- hospitalized in the surgical Intensive Care Unit (ICU) of the University Hospital of Saint-Etienne between September 2015 and August 2016 for medical-surgical pathologies
- requiring orotracheal intubation or tracheostomy
- and presenting a Riker sedation score of 3 or 4.
Key exclusion criteria (8 listed)
- cerebral palsy
- curarization
- paraplegia or tetraplegia
- intensive care neuromyopathy
- ocular pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Datas analysed by medical recordsDatas analysed by medical records : pupillary parameters: pupillary diameter and pupillary diameter variation. heart rate, the blood pressure, the Behavioral Pain Scale (BPS) pain score before and during painful procedures. The pupillary parameters were recorded with the AlgiScan® pupillometer (iDMed, Marseille, France), which allows the recording of Pupillary Diameter (PD) variations at the patient's bed at a sampling frequency of 67 hertz. | Other | Patients requiring orotracheal intubation or tracheostomy |
Primary outcome
Correlation between fluctuations in Pupillary Diameter (PD), as assessed by the Variation Coefficient of Pupillary Diameter (VCPD) and the level of pain.
Time frame: Months: 1
Variation Coefficient of Pupillary Diameter (VCPD) calculate from continuous pupil recordings during tracheal aspirations, considered as a painful procedure. The nurse in charge of the patient scored the Riker sedation score before endotracheal suctioning and the pain level estimated by the Behavioral Pain Scale (BPS) scale before and during endotracheal suctioning.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Intubation Complication
Recruiting
Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study
Intubation Complication
Recruiting
The ED-AWARENESS-2 Trial
Awareness, Mechanical Ventilation
RecruitingObservational study
Cardiovascular History and Hemodynamic Complications After Intubation in ICU
Hemodynamic Complications
Not yet recruiting
Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
Postoperative Pulmonary Complications
Not yet recruiting
Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics.
Intubation Skill, Intubation Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David CHARIER, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation Complication, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 5 Dec 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation between fluctuations in Pupillary Diameter (PD), as assessed by the Variation Coefficient of Pupillary Diameter (VCPD) and the level of pain. (time frame: Months: 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2022.