Sitting Versus Horizontal Position on Craniotomies

The Effects of Sitting Position on the Outcome During Surgery on Posterior Cranial Fossa and Pineal Region

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.

Study Overview

• Status: Completed
• Conditions: Brain Tumor; Craniotomy
• Intervention / Treatment: Procedure: Surgical position

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 Type: Observational
• Enrollment (Actual): 109

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective craniotomies on posterior cranial fossa or pineal region were identified on each site before surgery. Patients were asked to be part of the study explaining that no intervention was necessary besides a phone call performed by the research team 3 months after their surgery.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sitting Position; Sitting and semi-sitting	Procedure: Surgical position
Horizontal Position; Prone, lateral and park bench.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.
Patient satisfaction	Collected on phone script during follow-up phone call	End of surgery (closure) - 3 months after surgery

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Burdenko Neurosurgery Institute
• Investigators: Principal Investigator: Sergio Bergese, MD, Ohio State University

Publications and helpful links

General Publications

• Mavarez-Martinez A, Israelyan LA, Soghomonyan S, Fiorda-Diaz J, Sandhu G, Shimansky VN, Ammirati M, Palettas M, Lubnin AY, Bergese SD. The Effects of Patient Positioning on the Outcome During Posterior Cranial Fossa and Pineal Region Surgery. Front Surg. 2020 Mar 13;7:9. doi: 10.3389/fsurg.2020.00009. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): April 23, 2019
• Study Completion (Actual): April 23, 2019

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (Actual): December 6, 2017

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Posterior fossa; Pineal region
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: 2015H0035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data that underlie results in a publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No