Postoperative DeliriumNCT06255132
Automated Pupillometry in Patients Underwent Cardiac Surgery to Predict Postoperative Delirium
A study testing Automated pupillometer NPi-200 in people with Postoperative Delirium, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial summary
The rate of postoperative delirium in patients who underwent cardiac surgery is very high. Different predictors and/or scores were studied for the prediction of Post Operative Delirium (POD)after heart surgery, but none of them was validated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Automated pupillometer NPi-200
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 9 Mar 2023to Mar 2025
- 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
- Adult patients undergoing elective open cardiac surgery (>18 yr)
- Elective open cardiac surgery and cardiopulmonary bypass
Who cannot join
- Patients <18 years of age
- Emergency surgeries
- Heart operations, not including extracorporeal circulation
- Surgery for aortic arch dissection with hypothermia and/or circulatory arrest
- Patients affected by psychiatric disorders undergoing with or without neuroleptic therapy
- Patients who have the refused consent
- Patients with ocular problems (acute or previous trauma to one or both eyes, blindness, ocular prosthesis)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Unit of Cardiothoracic Anesthesia and Intensive Care, University hospital of Verona
Verona, Vr, 37126
Federico Romagnosi, MD, federico.romagnosi@aovr.veneto.it
About this study
Official title: Exploratory Study on the Role of Automated Pupillometry in Patients Underwent Cardiac Surgery to Predict Postoperative Delirium
The rate of postoperative delirium in patients who underwent cardiac surgery is very high. Different predictors and/or scores were studied for the prediction of Post Operative Delirium (POD)after heart surgery, but none of them was validated. The investigators aim to explore the role of pupillary alterations during anesthesia in open-heart surgery.
The goal of this prospective study is to evaluate if pupil alterations during cardiac surgery, evaluated by an automated pupillometer (NPi-200) ( AP), could predict postoperative delirium.
Read the detailed description
Consent was obtained during the hospitalization before the planned surgery.
On the day of surgery, before general anesthesia is started, Near-infrared spectroscopy (NIRS) sensors are applied to the patient's forehead bilaterally and the baseline value is recorded. Pupils' variables (i.e., diameter, % constriction, constriction velocity, dilation velocity, latency, NPi) are also recorded from both the right and left eye with AP (NPi-200).
From the induction of anesthesia, pupillary variables in both eyes are recorded and measured every 30' such as the concomitant NIRS values (at least one measurement per eye per operative phase). Moreover, hemodynamic and respiratory parameters concomitant with the pupillary measurements are measured.
Following surgery, the patient is transferred to the Cardiac Intensive Care Unit. There, NIRS monitoring as as well as automated pupillometry measurements will be maintained until the patient regains consciousness (defined as RASS sedation scale >-3).
Once the patient has regained consciousness (RASS>-3), is assessed twice a day (morning and afternoon) with the Confusion assessment method-intensive care unit (CAM-ICU) score by the nursing staff and/or medical staff. The presence or absence of POD will then be reported as well as any pharmacological and non-pharmacological treatments.
Any neurological complications and diagnostic investigations arising in the post-operative period will also be noted.
- Conditions
- Postoperative Delirium
- Being tested
- Automated pupillometer NPi-200
- Keywords
- automated pupillometry, cardiac surgical procedures
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated pupillometer NPi-200Device
Pupillary variables in both eyes are recorded and measured with NPi-200 every 30 minutes from the induction of anesthesia. At the end of the surgery, the patient is transferred to the intensive care unit (ICU), and the pupillary variables are recorded until the patient regains consciousness (Richmond agitation sedation scale, RASS>-3). Specific hemodynamic, respiratory, surgical, and EBP data are also recorded as well as NIRS variables.
As soon as the patient had regained consciousness (RASS > 3), they were assessed for delirium for a total period of five days. Nursing and/or medical staff administered the CAM-ICU score to patients twice a day (morning and afternoon).
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing open heart surgery | Experimental | Not described Receives: Device: Automated pupillometer NPi-200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between neurological pupil index (NPi) and Post-operative delirium
We want to relate pupillary reactivity, assessed with automated pupillometry such as the Neurological pupil index (numerical value:0-5) during surgery, with Postoperative delirium (assessed with CAM-ICU score during the first 5 postoperative days).
Measured: Intraoperative (day 0)
Secondary outcomes (4)
Correlation between early prediction model for delirium (E-PRE-DELIRIC) and POD
E-PREDELIRIC is a standard prediction model for ICU delirium (%) and is calculated at ICU admission. We aim to evaluate the correlation between the model and Postoperative delirium in cardiovascular patients
Measured: E-PREDELIRIC is calculated at ICU admission ( day 0)
Correlation between regional cerebral saturation (rSO2) and POD occurrence
Regional cerebral saturation (rSO2) ranges between 0 and 100% and is a standard of care during open heart surgery. We want to evaluate the correlation between intraoperative cerebral saturation during surgery and POD.
Measured: rSO2 is monitored during surgery (Day 0)
Correlation between Cardiopulmonary bypass duration and POD.
Cardiopulmonary bypass duration within heart surgery is variable (min), depending on different surgical factors. We aim to evaluate if the duration of CPB could be related to POD occurrence
Measured: Intraoperative
Multivariate model for POD prediction.
a multivariate analysis will be performed to build a prediction model for postoperative delirium in the specific population of cardiovascular patients who underwent open heart surgery.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start9 Mar 2023
- Primary completionSep 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leonardo Gottin, Prof., Study director, Universita di VeronaFederico Romagnosi, MD, Principal investigator, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255132
- Sponsor's protocol ID
- 4079CESC
- Status last verified
- Jan 2024
- First submitted
- 26 Oct 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on the Role of Automated Pupillometry in Patients Underwent Cardiac Surgery to Predict Postoperative Delirium
- ClinicalTrials.gov ID
- NCT06255132
- Acronym / sponsor ID
- 4079CESC
- Conditions
- Postoperative Delirium
- Keywords
- automated pupillometry, cardiac surgical procedures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 13 Feb 2024 (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.
The rate of postoperative delirium in patients who underwent cardiac surgery is very high. Different predictors and/or scores were studied for the prediction of Post Operative Delirium (POD)after heart surgery, but none of them was validated. The investigators aim to explore the role of pupillary alterations during anesthesia in open-heart surgery.
The goal of this prospective study is to evaluate if pupil alterations during cardiac surgery, evaluated by an automated pupillometer (NPi-200) ( AP), could predict postoperative delirium.
Detailed description
Consent was obtained during the hospitalization before the planned surgery.
On the day of surgery, before general anesthesia is started, Near-infrared spectroscopy (NIRS) sensors are applied to the patient's forehead bilaterally and the baseline value is recorded. Pupils' variables (i.e., diameter, % constriction, constriction velocity, dilation velocity, latency, NPi) are also recorded from both the right and left eye with AP (NPi-200).
From the induction of anesthesia, pupillary variables in both eyes are recorded and measured every 30' such as the concomitant NIRS values (at least one measurement per eye per operative phase). Moreover, hemodynamic and respiratory parameters concomitant with the pupillary measurements are measured.
Following surgery, the patient is transferred to the Cardiac Intensive Care Unit. There, NIRS monitoring as as well as automated pupillometry measurements will be maintained until the patient regains consciousness (defined as RASS sedation scale >-3).
Once the patient has regained consciousness (RASS>-3), is assessed twice a day (morning and afternoon) with the Confusion assessment method-intensive care unit (CAM-ICU) score by the nursing staff and/or medical staff. The presence or absence of POD will then be reported as well as any pharmacological and non-pharmacological treatments.
Any neurological complications and diagnostic investigations arising in the post-operative period will also be noted.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing open heart surgery | Experimental | Device: Automated pupillometer NPi-200 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients undergoing elective open cardiac surgery (>18 yr)
- Elective open cardiac surgery and cardiopulmonary bypass
Key exclusion criteria (7 listed)
- Patients <18 years of age
- Emergency surgeries
- Heart operations, not including extracorporeal circulation
- Surgery for aortic arch dissection with hypothermia and/or circulatory arrest
- Patients affected by psychiatric disorders undergoing with or without neuroleptic therapy
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 |
|---|---|---|
| Automated pupillometer NPi-200Pupillary variables in both eyes are recorded and measured with NPi-200 every 30 minutes from the induction of anesthesia. At the end of the surgery, the patient is transferred to the intensive care unit (ICU), and the pupillary variables are recorded until the patient regains consciousness (Richmond agitation sedation scale, RASS>-3). Specific hemodynamic, respiratory, surgical, and EBP data are also recorded as well as NIRS variables. As soon as the patient had regained consciousness (RASS > 3), they were assessed for delirium for a total period of five days. Nursing and/or medical staff administered the CAM-ICU score to patients twice a day (morning and afternoon). | Device | Patients undergoing open heart surgery |
Primary outcome
Correlation between neurological pupil index (NPi) and Post-operative delirium
Time frame: Intraoperative (day 0)
We want to relate pupillary reactivity, assessed with automated pupillometry such as the Neurological pupil index (numerical value:0-5) during surgery, with Postoperative delirium (assessed with CAM-ICU score during the first 5 postoperative days).
4 secondary outcomes
Correlation between early prediction model for delirium (E-PRE-DELIRIC) and POD
Time frame: E-PREDELIRIC is calculated at ICU admission ( day 0)
Correlation between regional cerebral saturation (rSO2) and POD occurrence
Time frame: rSO2 is monitored during surgery (Day 0)
Correlation between Cardiopulmonary bypass duration and POD.
Time frame: Intraoperative
Multivariate model for POD prediction.
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
Related trials for Postoperative Delirium
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The Danish Out-of-Hospital Cardiac Arrest Study
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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.
Leonardo Gottin, Prof. study director
Universita di Verona
Federico Romagnosi, MD principal investigator
Universita di Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated pupillometer NPi-200 in people with Postoperative Delirium, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
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 2 inclusion and 7 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 13 Feb 2024. 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 Italy. 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?
Contact Federico Romagnosi, MD (0458122621, federico.romagnosi@aovr.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between neurological pupil index (NPi) and Post-operative delirium (time frame: Intraoperative (day 0)). 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 13 Feb 2024.