Sitting Versus Horizontal Position on Craniotomies

Completed

• Conditions: Craniotomy; Brain Tumor
• Interventions: Procedure: Surgical position

• Registration Number: NCT03364283
• Lead Sponsor: Ohio State University

Brief Summary

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.

Detailed Description

This was a prospective observational study to assess the effects of patient positioning during craniotomies on surgical outcomes. Patients were distributed into 2 major groups based on the surgical position: sitting and horizontal. Each group was further divided into subgroups based on the type and location of the lesion. To achieve the study goals, comparison of the 2 approaches in equivalent patient groups was performed, including comparable demographics, diagnoses, topographic location of the lesions, anesthetic approaches, and surgical experience.

The operating surgeons decided patient positioning based on clinical judgment. Type of anesthesia was defined by the anesthesiologist in charge of the patient however, it was maximally standardized for both sites. All the surgeries were performed by neurosurgeons with sufficient experience of sitting craniotomies.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-12-05
• Study First Posted: 2017-12-06
• Primary Completion: 2019-04-23
• Study Completion: 2019-04-23
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-29
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sitting Position	Surgical position	Sitting and semi-sitting

Primary Outcome Measures

Name	Time	Method
Incidence of intraoperative air embolism	Time of surgery (From surgical wound incision time until wound closure)	Measured intraoperatively with transesophageal echocardiogram and/or PETCO2 levels

Secondary Outcome Measures

Name	Time	Method
Degree of tumor removal	End of surgery (closure) - Postoperative evaluation by surgeon and/or postoperative imaging performed up to 48 hours after end of surgery	Indicated by surgeon description and/or postoperative imaging
Patient satisfaction	End of surgery (closure) - 3 months after surgery	Collected on phone script during follow-up phone call
Neurological function	End of surgery (closure) - Discharge from the hospital or up to 3 months after end of surgery, whichever came first.	Compared sensory-motor function, cranial nerve function and Glasgow scale before and after surgery.