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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01476670
Other study ID # CA-CO2-TCD
Secondary ID Posterior fossa
Status Not yet recruiting
Phase N/A
First received November 18, 2011
Last updated November 21, 2011
Start date July 2012

Study information

Verified date November 2011
Source All India Institute of Medical Sciences, New Delhi
Contact Hemanshu Prabhakat, MD
Phone 9868398205
Email prabhakaraiims@yahoo.co.in
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
India All India Institute of Medical Sciences New Delhi Delhi

Sponsors (1)

Lead Sponsor Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

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