Sitting Versus Horizontal Position on Craniotomies

Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03364283
• Other study ID #: 2015H0035
• Status: Completed
• Start date: October 2015
• Est. completion date: April 23, 2019

Study information

• Verified date: September 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.)

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor
• Craniotomy

Intervention

Procedure:
• Surgical position

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Burdenko Neurosurgery Institute

Outcome

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