Clinical trial NCT03364283: Sitting Versus Horizontal Position on Craniotomies
Official title: The Effects of Sitting Position on the Outcome During Surgery on Posterior Cranial Fossa and Pineal Region
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Craniotomy
Brain Tumor
Keywords: Posterior fossa
Pineal region
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Burdenko Neurosurgery Institute
First posted: 2017-12-06
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.)

Primary outcomes:
measure: Incidence of intraoperative air embolism
timeFrame: Time of surgery (From surgical wound incision time until wound closure)
Secondary outcomes:
measure: Degree of tumor removal
timeFrame: End of surgery (closure) - Postoperative evaluation by surgeon and/or postoperative imaging performed up to 48 hours after end of surgery
measure: Neurological function
timeFrame: End of surgery (closure) - Discharge from the hospital or up to 3 months after end of surgery, whichever came first.
measure: Patient satisfaction
timeFrame: End of surgery (closure) - 3 months after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Ohio State University
name: Sergio Bergese, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.