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Heartrate Variability and Intraoperative Brain Conditions in Supratentorial Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04094974
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
DyAnsys, Inc.

Brief Summary:
This study aims to determine the relationship between heart rate variability and intraoperative brain relaxation conditions in patients with brain tumors.

Condition or disease Intervention/treatment
Supratentorial Brain Tumors Device: ANSiscope

Detailed Description:
Patients undergoing brain surgery for treatment of brain tumors will be studied to determine the relationship between heart rate variability and intraoperative brain relaxation conditions.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Usefulness of the Combination of Preoperative Assessment of Optic Nerve Sheath Diameter and Heart Rate Variability to Predict Intraoperative Brain Condition in Patients With Supratentorial Tumors
Actual Study Start Date : October 12, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: ANSiscope
    Heart rate variability will be assessed using ansiscope before surgery


Primary Outcome Measures :
  1. Brain relaxation [ Time Frame: 2hours ]
    1. Tight Brain-the brain surface is jutting out or expanding beyond the craniotomy margins, brain pulsations are not clearly defined.
    2. Brain surface at level of craniotomy margins, Brain pulsations faintly observed
    3. Brain surface just below the surface of craniotomy margin. Brain pulsations well seen.
    4. Brain surface well below the surface of craniotomy margin, well retracted in to the cranial cavity with good brain pulsations.Brain relaxation score will me measured only once. There is no follow up


Secondary Outcome Measures :
  1. Hemodynamic Measurement-Heartrate [ Time Frame: 2hours ]
    The change in hemodynamic variable heart rate in beats per minute will be measured through the study period

  2. Hemodynamic Measurement-Bloodpressure [ Time Frame: 2hours ]
    The change in hemodynamic variable blood pressure in mmHg will be measured through the study period



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients of either sex with supratentorial brain lesions who are posted for neurosurgery will be taken as study population. Patients who meet the inclusion criteria and give consent for the study will be included in the study
Criteria

Inclusion Criteria:

  • Patient aged 18 to 75 years
  • ASA(American Society of Anesthesiologists ) I - III
  • Patients undergoing surgery for supratentorial tumors
  • Glasgow coma scale > 10

Exclusion Criteria:

  • Patient aged below 18 and above 75 years.
  • Pregnancy
  • ASA(American Society of Anesthesiologists) IV-V
  • Previous cranial surgery
  • Morbid obesity ( BMI>40)
  • Ocular injury/ Glaucoma
  • Head injury
  • Patient on beta blockers, ACE(angiotensin-converting-enzyme) inhibitors, Clonidine
  • Diabetes mellitus for more than 5 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04094974


Contacts
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Contact: Murugesh K, CEO 9840967384 k.murugesh@dyansys.com
Contact: Priyadharshini G, R&D 8939173072 g.priyadharshini@dyansys.com

Locations
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India
National Institute of Mental Health and Neurosciences Recruiting
Bengaluru, Karnataka, India, 560029
Contact: Dr.Mathangi krishnakumar, MBBS,MD,DM    09764062212      
Contact: Robin Mariyaselvam, Post B.Sc    7259177671    robinrose333@gmail.com   
Sponsors and Collaborators
DyAnsys, Inc.
Investigators
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Principal Investigator: Dr. Mathangi Krishnakumar, MBBS,MD,DM NIMHANS,Bengaluru

Publications:

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Responsible Party: DyAnsys, Inc.
ClinicalTrials.gov Identifier: NCT04094974    
Other Study ID Numbers: CS009
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by DyAnsys, Inc.:
Heart rate variability,
supratentorial brain tumors
optic nerve sheath diameter
Additional relevant MeSH terms:
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Brain Neoplasms
Supratentorial Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases