Intraoperative Neurophysiological MonitoringNCT02916069
Multi Modal Brain Monitoring and Cardiac Surgery
A study testing Nearinfrared Spectroscopy (NIRS), Transcranial Doppler (TCD) and Bispectral index (BIS) in people with Intraoperative Neurophysiological Monitoring, run by Assiut University at 1 site in Egypt.
Trial summary
Multimodal brain monitoring is feasible and can be used in formulating therapeutic strategies during cardiac surgery. Such monitoring may help to improve patient outcome and to reduce costs after cardiac surgery with CPB. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intraoperative Neurophysiological Monitoring
- What is being tested?
- Nearinfrared Spectroscopy (NIRS), Transcranial Doppler (TCD) and Bispectral index (BIS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2016to May 2018
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective cardiac surgery with cardiopulmonary bypass
- Valve replacement
- Coronary artery bypass
Who cannot join
- Emergency surgery
- Hepatic
- Renal impairment
- Diabetes Mellitus
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine Assiut University
Asyut, 74111
Sayed K Abd-Elshafy, MD
About this study
Official title: The Impact Multi Modal Brain Monitoring on Patient Out Come After Adult Cardiac Surgery
Multimodal brain monitoring is feasible and can be used in formulating therapeutic strategies during cardiac surgery. Such monitoring may help to improve patient outcome and to reduce costs after cardiac surgery with CPB.
Read the detailed description
The aim of this study is to use a combination of brain monitoring {Nearinfrared Spectroscopy (NIRS), Transcranial Doppler (TCD), bispectral index (BIS)} to formulate therapeutic strategies based on these monitors and to evaluate the impact on patient outcome.
- Being tested
- Nearinfrared Spectroscopy (NIRS), Transcranial Doppler (TCD), Bispectral index (BIS)
- Keywords
- Spectroscopy, Transcranial Doppler, Bispectral index, Cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nearinfrared Spectroscopy (NIRS)Device
Patients will be monitored and interference will be done to optimize the medical condition based on such monitor
Transcranial Doppler (TCD)Device
Patients will be monitored and interference will be done to optimize the medical condition based on such monitor
Bispectral index (BIS)Device
Patients will be monitored and interference will be done to optimize the medical condition based on such monitor
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Multimodal brain monitoring) | Active comparator | Patients will be monitored with combination of brain monitoring; Nearinfrared Spectroscopy (NIRS), Transcranial Doppler (TCD), and Bispectral index (BIS). Interference will be done to optimize the medical condition based on such monitors. Receives: Device: Nearinfrared Spectroscopy (NIRS); Device: Transcranial Doppler (TCD); Device: Bispectral index (BIS) |
| Group 2 | No intervention | Patients will be monitored without any interference based on such monitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
S100 protein
S100 protein (marker of brain injury)
Measured: up to 24 hours
Secondary outcomes (5)
Mini-mental state examination
Measured: up to 30 days after surgery
Western perioperative neurological scale
Measured: up to 30 days after surgery
Major neurological out come as stoke
Measured: up to 30 days after surgery
Duration of mechanical ventilation
Measured: up to 30 days after surgery
Hospital stay
Measured: up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Neurophysiological MonitoringStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Mohamed Shaaban Ali, PhD, MD, Assiut University
- Investigators
- Mohamed Ali, PhD. MD, Principal investigator, associate professor of anesthesia and critical care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916069
- Sponsor's protocol ID
- IRB00008715621
- Status last verified
- Jul 2017
- First submitted
- 16 Sep 2016
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact Multi Modal Brain Monitoring on Patient Out Come After Adult Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02916069
- Acronym / sponsor ID
- IRB00008715621
- Keywords
- Spectroscopy, Transcranial Doppler, Bispectral index, Cardiac surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 27 Sep 2016 (estimated)
- 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.
Multimodal brain monitoring is feasible and can be used in formulating therapeutic strategies during cardiac surgery. Such monitoring may help to improve patient outcome and to reduce costs after cardiac surgery with CPB.
Detailed description
The aim of this study is to use a combination of brain monitoring {Nearinfrared Spectroscopy (NIRS), Transcranial Doppler (TCD), bispectral index (BIS)} to formulate therapeutic strategies based on these monitors and to evaluate the impact on patient outcome.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Multimodal brain monitoring) | Active comparator | Device: Nearinfrared Spectroscopy (NIRS), Device: Transcranial Doppler (TCD), Device: Bispectral index (BIS)Patients will be monitored with combination of brain monitoring; Nearinfrared Spectroscopy (NIRS), Transcranial Doppler (TCD), and Bispectral index (BIS). Interference will be done to optimize the medical condition based on such monitors. |
| Group 2 | No intervention | –Patients will be monitored without any interference based on such monitors |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective cardiac surgery with cardiopulmonary bypass
- Valve replacement
- Coronary artery bypass
Key exclusion criteria (4 listed)
- Emergency surgery
- Hepatic
- Renal impairment
- Diabetes Mellitus
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 |
|---|---|---|
| Nearinfrared Spectroscopy (NIRS)Patients will be monitored and interference will be done to optimize the medical condition based on such monitor | Device | Group 1 (Multimodal brain monitoring) |
| Transcranial Doppler (TCD)Patients will be monitored and interference will be done to optimize the medical condition based on such monitor | Device | Group 1 (Multimodal brain monitoring) |
| Bispectral index (BIS)Patients will be monitored and interference will be done to optimize the medical condition based on such monitor | Device | Group 1 (Multimodal brain monitoring) |
Primary outcome
S100 protein
Time frame: up to 24 hours
S100 protein (marker of brain injury)
5 secondary outcomes
Mini-mental state examination
Time frame: up to 30 days after surgery
Western perioperative neurological scale
Time frame: up to 30 days after surgery
Major neurological out come as stoke
Time frame: up to 30 days after surgery
Duration of mechanical ventilation
Time frame: up to 30 days after surgery
Hospital stay
Time frame: up to 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Intraoperative Neurophysiological Monitoring
Not yet recruiting
Endotracheal Tube Versus Transcartilage Needle Electrodes for Nerve Monitoring in Thyroid Surgery
Thyroid Diseases, Recurrent Laryngeal Nerve Injury
Not yet recruitingPhase 4
Remimazolam vs Propofol for Motor and Somatosensory Evoked Potentials in Spinal Tumor Surgery
Spinal Cord Neoplasms, Spinal Neoplasms
RecruitingPhase 3
Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients
Vestibular Schwannoma, Facial Nerve Paralysis
Enrolling by invitationObservational study
Neurophysiological Intraoperative or Epilepsy Monitoring
Patients Operated on at the Neurosurgery Department
RecruitingObservational study
Immunonutrition and Neuromonitoring for Postoperative Delirium in Gynecologic Oncology
Postoperative Delirium (POD), Gynecologic Cancers
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.
Mohamed Ali, PhD. MD principal investigator
associate professor of anesthesia and critical care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nearinfrared Spectroscopy (NIRS), Transcranial Doppler (TCD) and Bispectral index (BIS) in people with Intraoperative Neurophysiological Monitoring, run by Assiut University at 1 site in Egypt.
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 4 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 6 Jul 2017. 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 Egypt. 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 Mohamed Ali, PhD. MD (0020882413201, msali58@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
S100 protein (time frame: up to 24 hours). 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 6 Jul 2017.