Assessment of Cerebral Microvascular Circulation | NCT02179840

Studies
Assessment of Cerebral Microvascular Circulation

NCT02179840

Sponsor

University of California, San Francisco

Status

Withdrawn

Last Update Posted

Jan 8, 2019Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Cerebral Microvascular Circulation

Interventions

Mechanical ventilation adjustment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study not initiated, no participants enrolled.

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Jun 2015Estimated

Completion Date

Mar 2016Estimated

First Submitted Date

Jun 23, 2014

First Submission Date that Met QC Criteria

Jul 1, 2014

First Posted Date

Jul 2, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2019

Last Update Posted Date

Jan 8, 2019Actual

Name	Class
Tufts University	OTHER
University of California, Irvine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intravenous	Active Comparator	Anesthesia is maintained via intravenous agents. Mechanical ventilation adjustment will be performed.	Procedure: Mechanical ventilation adjustment
Inhalational	Active Comparator	Anesthesia is maintained via inhalational agents. Mechanical ventilation adjustment will be performed.	Procedure: Mechanical ventilation adjustment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mechanical ventilation adjustment	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cerebral oximetry	Cerebral blood flow capillary transit time and cerebral autoregulation	3 minutes following the intervention

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Patients <18 years of age
ASA physical status ≥III
Emergent or urgent surgery
Laparoscopic surgery
History of pulmonary diseases including COPD
Asthma
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided