NCT01476670

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
Last Updated

November 22, 2011

Status Verified

November 1, 2011

First QC Date

November 18, 2011

Last Update Submit

November 21, 2011

Conditions

Brain Tumor

Keywords

Posterior fossa brain tumorCerebral blood flowCerebral autoregulationCarbon dioxide reactivityTranscranial Doppler

Study Arms (1)

Posterior fossa tumor

Patients with posterior fossa tumor scheduled for elective surgery will be enrolled in the study.

Other: Monitoring

Interventions

MonitoringOTHER

Transcranial Doppler will be used to assess the cerebral autoregulation and carbon dioxide reactivity of patients with posterior fossa tumor

Posterior fossa tumor

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Hemanshu Prabhakar, MD

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hemanshu Prabhakat, MD

CONTACT

9868398205prabhakaraiims@yahoo.co.in

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 18, 2011

First Posted

November 22, 2011

Study Start

July 1, 2012

Last Updated

November 22, 2011

Record last verified: 2011-11

Locations

IN(1)