Delirium Clinical Trial
— Techno-5Official title:
Validation of Cerebral Non-invasive Monitoring and Prediction of Post-operative Delirium and Outcomes: A Prospective Observational Study
Verified date | March 2024 |
Source | Montreal Heart Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Brain monitoring using near-infrared spectroscopy (NIRS) started in 2002 in the operating room of the Montreal heart Institute (MHI). This was followed by the use of somatic NIRS in 2010, transcranial Doppler in 2015 and processed electroencephalogram (pEEG) using Sedline (Masimo, Irvine CA) in 2017. The introduction of those modalities led to significant change in intraoperative management. The goal of these devices is to improve our ability to detect and predict post-operative complications as well as offering insights on how to prevent them. The current project explores in further detail the impact of the introduction of pEEG in the operating room and in the intensive care unit (ICU) on post-operative delirium.
Status | Completed |
Enrollment | 153 |
Est. completion date | November 30, 2023 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Male or female patients, age 18 and older, undergoing cardiac surgery with CPB or off pump CABG Exclusion Criteria: - Patient with a critical pre-operative state defined as any of the following: vasopressor requirement, mechanical circulatory support, dialysis, mechanical ventilation, cardiac arrest necessitating resuscitation, aborted sudden death, preoperative cardiac massage, preoperative intra-aortic balloon pump. - Patient with the diagnosis of delirium at any point before surgery during the current hospitalization - Emergent surgery - Surgery under deep hypothermic circulatory arrest |
Country | Name | City | State |
---|---|---|---|
Canada | Montreal Heart Institute | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Montreal Heart Institute | Masimo Corporation |
Canada,
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* Note: There are 104 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of neurological events | Events will be categorized according to change in oxygen saturation measured by near infra-red spectroscopy and according to changes in pEEG activity evaluated by the patient state index, burst suppression ratio and spectral edge frequency. Events will be categorized based on the following classification:
Cerebral desaturation (>10% from baseline) AND a decrease in pEEG activity (patient state index (PSI) < 40 and/or burst suppression ratio (BSR) >0 and/or spectral edge frequency (SEF) <10) Cerebral desaturation (>10% from baseline) AND an increase in pEEG activity (PSI = 60, BSR = 0, SEF > 15) Cerebral desaturation (>10% from baseline) AND a normal pEEG activity (PSI = 40-60, BSR = 0 and SEF 10-15) Normal cerebral saturation (Cerebral desaturation =10% from baseline) AND a decrease in pEEG activity (PSI < 40, and/or BSR >0 and/or SEF<10). |
72 hours | |
Secondary | Rate of cognitive dysfunction | Cognitive dysfunction will be defined as a Delirium Index Score =1 | 72 hours | |
Secondary | Rate of delirium | Delirium will be defined as an Intensive Care Delirium Screening Checklist (ICDSC) : score of =4 | 72 hours | |
Secondary | Duration of persistent organ dysfunction | Persistent organ dysfunction is defined as one or more of the following: mechanical ventilation; vasopressor therapy (ongoing need for vasopressor agents such as norepinephrine, epinephrine, vasopressin, dopamine >5 µg/kg/min, or phenylephrine >50 µg/min); mechanical circulatory support (ongoing need for mechanical devices such as ECMO or IABP); new continuous renal replacement therapy or new intermittent hemodialysis (first to last dialysis session). Therefore, TPOD represent the time for which the patient requires invasive life support after cardiac surgery.
2. ICU stay (in hours) 3. Duration of hospital stay (in days) |
Up to 28 days or until hospital discharge | |
Secondary | Rate of all cause death during hospitalization | Death from any cause | Up to 30 days or until hospital discharge | |
Secondary | Rate of acute kidney injury | Defined according to KDIGO serum creatinine criteria: Increase of =27 umol/L within 48 hours or =50% | Up to 30 days or until hospital discharge | |
Secondary | Rate of major bleeding | Defined by the Bleeding Academic Research Consortium as one of the following:
Perioperative intracranial bleeding within 48h ii. Reoperation after closure of sternotomy for the purpose of controlling bleeding iii. Transfusion of =5 units of whole blood of packed red blood cells within a 48 hours period iv. Chest tube output =2L within a 24 hours period. |
Up to 30 days or until hospital discharge | |
Secondary | Rate of surgical re-intervention | Second surgery within the same hospitalization for any reason | Up to 30 days or until hospital discharge | |
Secondary | Rate of stroke | Central neurologic deficit persisting longer than 72 hours | Up to 30 days or until hospital discharge | |
Secondary | Duration of mechanical ventilation | Duration of mechanical support with a respirator in an intubated patient | Up to 30 days or until hospital discharge |
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