Brain Tumor Clinical Trial
Official title:
The Effects of Sitting Position on the Outcome During Surgery on Posterior Cranial Fossa and Pineal Region
NCT number | NCT03364283 |
Other study ID # | 2015H0035 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2015 |
Est. completion date | April 23, 2019 |
Verified date | September 2023 |
Source | Ohio State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The main objectives of this study are comparison of the incidence of intraoperative air embolism and the extent of blood loss in patients undergoing posterior cranial fossa (PCF) and pineal region (PR) surgeries in sitting and horizontal position. Additionally, the overall treatment outcome, neurological functional outcome, degree of tumor removal, clinical course in the postoperative period, and the patient satisfaction will be compared between the groups.
Status | Completed |
Enrollment | 109 |
Est. completion date | April 23, 2019 |
Est. primary completion date | April 23, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Patients 18 - 75 years old undergoing open posterior cranial fossa and pineal region surgery and diagnosed with space-occupying or vascular lesions willing consent to participate in the study. Exclusion Criteria: - Significant cardio-vascular comorbid conditions (cardiac insufficiency, recent infarction, advanced arterial hypertension) - Advanced chronic respiratory comorbid conditions - Uncorrected hypovolemia, anemia, hypoalbuminemia - De-compensated acid base and electrolyte disorders - Anticoagulated patients and patients with coagulation disorders, deep venous thrombosis (history of deep vein thrombosis or clinically established) - Preoperative evidence of spinal or peripheral nerve dysfunction that may interfere with patient positioning. - Cervical myelopathy - Cervical spine disorders (atlanto-occipital arthritis, previous fractures etc.) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ohio State University | Burdenko Neurosurgery Institute |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of intraoperative air embolism | Measured intraoperatively with transesophageal echocardiogram and/or PETCO2 levels | Time of surgery (From surgical wound incision time until wound closure) | |
Secondary | Degree of tumor removal | Indicated by surgeon description and/or postoperative imaging | End of surgery (closure) - Postoperative evaluation by surgeon and/or postoperative imaging performed up to 48 hours after end of surgery | |
Secondary | Neurological function | Compared sensory-motor function, cranial nerve function and Glasgow scale before and after surgery. | End of surgery (closure) - Discharge from the hospital or up to 3 months after end of surgery, whichever came first. | |
Secondary | Patient satisfaction | Collected on phone script during follow-up phone call | End of surgery (closure) - 3 months after surgery |
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