Cerebral Microvascular CirculationCHS-BrainNCT02179840
Assessment of Cerebral Microvascular Circulation
A study testing Mechanical ventilation adjustment in people with Cerebral Microvascular Circulation, run by University of California, San Francisco at 1 site in United States.
Trial summary
One of the fundamental goals of anesthesia care is to optimize tissue perfusion and oxygenation, especially in critically ill patients. The standard monitors such as blood pressure, heart rate and pulse oximetry do not directly reflect tissue information and can be misleading sometimes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cerebral Microvascular Circulation
- What is being tested?
- Mechanical ventilation adjustment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Mar 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are 18 years of age or older
- Relative healthy (ASA I-II)
- Scheduled for elective intra-abdominal surgeries including colorectal, urological and gynecological procedures under general anesthesia with placements of endotracheal tube and radial arterial catheter.
- Paralysis is required for surgery
- A total of 30 patients will be recruited. These 30 patients are randomly divided into 2 groups based on the technique of anesthesia maintenance during surgery. The anesthesia in one group (n=15) is maintained using inhalational agent. The anesthesia in the other group (n=15) is maintained using intravenous agents.
Who cannot join
- Patients <18 years of age
- ASA physical status ≥III
- Emergent or urgent surgery
- Laparoscopic surgery
- History of pulmonary diseases including COPD
- Asthma
Show all 9Show fewer
- Restrictive lung disease, etc.
- History of cardiac diseases including symptomatic coronary artery disease, heart failure, arrhythmia, moderate to severe valvular abnormalities, and cardiomyopathies
- History of neurological diseases including carotid artery disease, stroke or TIA, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Coherent Hemodynamics Spectroscopy (CHS) as a New Tool for Monitoring Cerebral Blood Flow and Autoregulation at the Microvascular Level
One of the fundamental goals of anesthesia care is to optimize tissue perfusion and oxygenation, especially in critically ill patients. The standard monitors such as blood pressure, heart rate and pulse oximetry do not directly reflect tissue information and can be misleading sometimes. Coherent hemodynamics spectroscopy (CHS) based on cerebral oximetry is proposed as a continuous and non-invasive tool assessing cerebral microvascular hemodynamics. The investigators propose this study to explore the validity of CHS via comparison with transcranial Doppler measurement in anesthetized surgical patients. The hypotheses are: 1) CHS can effectively measure cerebral microvascular hemodynamic changes associated with mechanical ventilation adjustment during anesthesia. 2) CHS can assess functional status of cerebral autoregulation that is altered by hypercapnia and inhalational anesthetic agent.
Read the detailed description
One of the essential goals in taking care of anesthetized surgical patients is to maintain adequate tissue perfusion and oxygenation. This is especially true for vital organs like the brain. Unfortunately, neither cerebral oxygen consumption nor cerebral oxygen delivery are directly monitored in the clinical setting while this type of information is of particular importance when taking care of patients inflicted with critical neurologic conditions. In addition, cerebral autoregulation - the mechanism of maintaining a constant cerebral blood flow in the face of arterial blood pressure fluctuation, is also not routinely monitored. The recent establishment of Coherent Hemodynamics Spectroscopy (CHS) is promising in offering what is needed in this context. The uniqueness of CHS is that it does not add any additional monitoring modality other than the cerebral oximeter based on near-infrared spectroscopy (NIRS) that is currently used in clinical care. However, CHS is based on its own innovative algorithm that quantifies microvascular cerebral blood flow and oxygen consumption, separates arterial and venous blood, and assesses functional status of cerebral autoregulation while the conventional cerebral oximeters do not. The investigators have established collaborations with Dr. Fantini from Tufts University and Dr. Tromberg from Beckman Laser Institute who are both leading scientists in Biophotonics research and development. Based on the clinical strength at UCSF, it is the investigators collaborative plan to explore the clinical application of CHS in patients with and without intracranial pathophysiologies. The study protocol has been submitted for review at UCSF.
- Conditions
- Cerebral Microvascular Circulation
- Being tested
- Mechanical ventilation adjustment
- Keywords
- Cerebral microvascular circulation, Cerebral autoregulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ventilation adjustmentProcedure or surgery
Mechanical ventilation adjustment and study procedure: This is a validation study of the CHS method in assessing cerebral microvascular hemodynamic changes. Cyclical physiological events such as respiration are essential in CHS methodology. The previous study shows that the robust measurement of the CHS method occurs at a respiratory rate of about 4-10 breaths per minute. Therefore, we propose the following respiration adjustment in this study with the consideration that CO2 is a powerful regulator of cerebral blood flow. Blood gas analysis will be performed during the 1st and 2nd rounds of ventilation adjustment.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous | Active comparator | Anesthesia is maintained via intravenous agents. Mechanical ventilation adjustment will be performed. Receives: Procedure: Mechanical ventilation adjustment |
| Inhalational | Active comparator | Anesthesia is maintained via inhalational agents. Mechanical ventilation adjustment will be performed. Receives: Procedure: Mechanical ventilation adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral oximetry
Cerebral blood flow capillary transit time and cerebral autoregulation
Measured: 3 minutes following the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startMar 2015
- Primary completionJun 2015 (estimated)
- Study completionMar 2016 (estimated)
Why it stopped: Study not initiated, no participants enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Microvascular CirculationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Tufts University, University of California, Irvine
- Responsible party
- Sponsor
- Investigators
- Lingzhong Meng, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179840
- Sponsor's protocol ID
- CHS-Brain
- Acronym
- CHS-Brain
- Status last verified
- Jan 2019
- First submitted
- 23 Jun 2014
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Coherent Hemodynamics Spectroscopy (CHS) as a New Tool for Monitoring Cerebral Blood Flow and Autoregulation at the Microvascular Level
- ClinicalTrials.gov ID
- NCT02179840
- Acronym / sponsor ID
- CHS-Brain / CHS-Brain
- Conditions
- Cerebral Microvascular Circulation
- Keywords
- Cerebral microvascular circulation, Cerebral autoregulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not initiated, no participants enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Tufts University, University of California, Irvine
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 2 Jul 2014 (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.
One of the fundamental goals of anesthesia care is to optimize tissue perfusion and oxygenation, especially in critically ill patients. The standard monitors such as blood pressure, heart rate and pulse oximetry do not directly reflect tissue information and can be misleading sometimes. Coherent hemodynamics spectroscopy (CHS) based on cerebral oximetry is proposed as a continuous and non-invasive tool assessing cerebral microvascular hemodynamics. The investigators propose this study to explore the validity of CHS via comparison with transcranial Doppler measurement in anesthetized surgical patients. The hypotheses are: 1) CHS can effectively measure cerebral microvascular hemodynamic changes associated with mechanical ventilation adjustment during anesthesia. 2) CHS can assess functional status of cerebral autoregulation that is altered by hypercapnia and inhalational anesthetic agent.
Detailed description
One of the essential goals in taking care of anesthetized surgical patients is to maintain adequate tissue perfusion and oxygenation. This is especially true for vital organs like the brain. Unfortunately, neither cerebral oxygen consumption nor cerebral oxygen delivery are directly monitored in the clinical setting while this type of information is of particular importance when taking care of patients inflicted with critical neurologic conditions. In addition, cerebral autoregulation - the mechanism of maintaining a constant cerebral blood flow in the face of arterial blood pressure fluctuation, is also not routinely monitored. The recent establishment of Coherent Hemodynamics Spectroscopy (CHS) is promising in offering what is needed in this context. The uniqueness of CHS is that it does not add any additional monitoring modality other than the cerebral oximeter based on near-infrared spectroscopy (NIRS) that is currently used in clinical care. However, CHS is based on its own innovative algorithm that quantifies microvascular cerebral blood flow and oxygen consumption, separates arterial and venous blood, and assesses functional status of cerebral autoregulation while the conventional cerebral oximeters do not. The investigators have established collaborations with Dr. Fantini from Tufts University and Dr. Tromberg from Beckman Laser Institute who are both leading scientists in Biophotonics research and development. Based on the clinical strength at UCSF, it is the investigators collaborative plan to explore the clinical application of CHS in patients with and without intracranial pathophysiologies. The study protocol has been submitted for review at UCSF.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous | Active comparator | Procedure: Mechanical ventilation adjustmentAnesthesia is maintained via intravenous agents. Mechanical ventilation adjustment will be performed. |
| Inhalational | Active comparator | Procedure: Mechanical ventilation adjustmentAnesthesia is maintained via inhalational agents. Mechanical ventilation adjustment will be performed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients are 18 years of age or older
- Relative healthy (ASA I-II)
- Scheduled for elective intra-abdominal surgeries including colorectal, urological and gynecological procedures under general anesthesia with placements of endotracheal tube and radial arterial catheter.
- Paralysis is required for surgery
- A total of 30 patients will be recruited. These 30 patients are randomly divided into 2 groups based on the technique of anesthesia maintenance during surgery. The anesthesia in one group (n=15) is maintained using inhalational agent. The anesthesia in the other group (n=15) is maintained using intravenous agents.
Key exclusion criteria (9 listed)
- Patients <18 years of age
- ASA physical status ≥III
- Emergent or urgent surgery
- Laparoscopic surgery
- History of pulmonary diseases including COPD
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 |
|---|---|---|
| Mechanical ventilation adjustmentMechanical ventilation adjustment and study procedure: This is a validation study of the CHS method in assessing cerebral microvascular hemodynamic changes. Cyclical physiological events such as respiration are essential in CHS methodology. The previous study shows that the robust measurement of the CHS method occurs at a respiratory rate of about 4-10 breaths per minute. Therefore, we propose the following respiration adjustment in this study with the consideration that CO2 is a powerful regulator of cerebral blood flow. Blood gas analysis will be performed during the 1st and 2nd rounds of ventilation adjustment. | Procedure or surgery | Inhalational, Intravenous |
Primary outcome
cerebral oximetry
Time frame: 3 minutes following the intervention
Cerebral blood flow capillary transit time and cerebral autoregulation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
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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.
Lingzhong Meng principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical ventilation adjustment in people with Cerebral Microvascular Circulation, run by University of California, San Francisco at 1 site in United States.
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 5 inclusion and 9 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: withdrawn, as of the sponsor's last update on 8 Jan 2019. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
cerebral oximetry (time frame: 3 minutes following the intervention). 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 8 Jan 2019.