Sitting Versus Horizontal Position on Craniotomies

NCT ID: NCT03364283

Last Updated: 2023-10-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 109 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2019-04-23

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.

Conditions

Craniotomy; Brain Tumor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Sitting Position

Sitting and semi-sitting

Surgical position

Intervention Type: PROCEDURE

Horizontal Position

Prone, lateral and park bench.

No interventions assigned to this group

Interventions

Surgical position

Intervention Type: PROCEDURE

Eligibility Criteria

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Burdenko Neurosurgery Institute

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sergio Bergese, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

References

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.

Reference Type: DERIVED

PMID: 32232048 (View on PubMed)

Other Identifiers

2015H0035

Identifier Type: -

Identifier Source: org_study_id