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Cerebral Blood Circulation in Patients With Posterior Fossa Brain Tumor

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2011 by Hemanshu Prabhakar, All India Institute of Medical Sciences, New Delhi.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01476670
First Posted: November 22, 2011
Last Update Posted: November 22, 2011
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Hemanshu Prabhakar, All India Institute of Medical Sciences, New Delhi
  Purpose

The normal cerebral blood flow is guided by factors such as cerebral autoregulation (CA) and carbon dioxide reactivity (CO2R). Authors have demonstrated that CA and CO2R may be impaired in presence of intracranial tumors.Most studies pertaining to assessment of CA and CO2R in patients with brain tumors is limited to supratentorial tumors. Due to their anatomic location, posterior fossa tumors result in obstruction of ventricular outflow, produce hydrocephalus and features of raise intracranial pressure (ICP). It is possible that lesions in the posterior fossa may affect CA and CO2R. It should also be noted that posterior fossa surgeries are carried out in positions such as prone, lateral and sitting. Altered surgical positions themselves affect systemic hemodynamics which may influence cerebral blood flow; with presence of anesthetics further compromising the blood flow to the brain. Understanding the homeostatic mechanisms of CA and CO2R may help in deciding proper positioning of patients and maintenance of intraoperative hemodynamic.

The aim of this observational study was to evaluate CA and CO2R in patients with posterior fossa tumor prior to surgical decompression of the lesion.


Condition Intervention
Brain Tumor Other: Monitoring

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cerebral Autoregulation and Carbon Dioxide Reactivity in Patients With Posterior Fossa Tumor

Resource links provided by NLM:


Further study details as provided by Hemanshu Prabhakar, All India Institute of Medical Sciences, New Delhi:

Estimated Enrollment: 20
Study Start Date: July 2012
Groups/Cohorts Assigned Interventions
Posterior fossa tumor
Patients with posterior fossa tumor scheduled for elective surgery will be enrolled in the study.
Other: Monitoring
Transcranial Doppler will be used to assess the cerebral autoregulation and carbon dioxide reactivity of patients with posterior fossa tumor

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Due to their anatomic location, posterior fossa tumors result in obstruction of ventricular outflow, produce hydrocephalus and features of raise intracranial pressure (ICP). It is possible that lesions in the posterior fossa may affect Cerebral Autoregulation and Carbon dioxide reactivity. It should also be noted that posterior fossa surgeries are carried out in positions such as prone, lateral and sitting. Altered surgical positions themselves affect systemic hemodynamics which may influence cerebral blood flow; with presence of anesthetics further compromising the blood flow to the brain. Understanding the homeostatic mechanisms of CA and CO2R may help in deciding proper positioning of patients and maintenance of intraoperative hemodynamic.
Criteria

Inclusion Criteria:

  • All patients with posterior fossa tumor
  • Scheduled for elective surgery
  • History of recent ventriculoperitoneal shunt (within 24 hours)

Exclusion Criteria:

  • previous craniotomy
  • patients on ventilatory support
  • history of cerebrovascular accident
  • syncope or carotid artery disease
  • anemia
  • polycythemia
  • patients on vasoactive medications
  • those suffering from medical conditions such as diabetes mellitus and hypertension.
  Contacts and Locations
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): NCT01476670


Contacts
Contact: Hemanshu Prabhakat, MD 9868398205 prabhakaraiims@yahoo.co.in

Locations
India
All India Institute of Medical Sciences Not yet recruiting
New Delhi, Delhi, India, 110029
Contact: Hemanshu Prabhakar, MD    91_9868398205    prabhakaraiims@yahoo.co.in   
Principal Investigator: Hemanshu Prabhakar, MD         
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Principal Investigator: Hemanshu Prabhakar, MD All India Institute of Medical Sciences, New Delhi
  More Information

Responsible Party: Hemanshu Prabhakar, Dr., All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT01476670     History of Changes
Other Study ID Numbers: CA-CO2-TCD
Posterior fossa tumor - TCD ( Other Identifier: AIIMS )
First Submitted: November 18, 2011
First Posted: November 22, 2011
Last Update Posted: November 22, 2011
Last Verified: November 2011

Keywords provided by Hemanshu Prabhakar, All India Institute of Medical Sciences, New Delhi:
Posterior fossa brain tumor
Cerebral blood flow
Cerebral autoregulation
Carbon dioxide reactivity
Transcranial Doppler

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases