Sitting Versus Horizontal Position on Craniotomies

NCT03364283 | Completed

• 1 other identifier: 2015H0035
• Study Type: observational
• Target: 109
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Craniotomy; Brain Tumor

Keywords

Posterior fossa; Pineal region

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Neurological function

  End of surgery (closure) - Discharge from the hospital or up to 3 months after end of surgery, whichever came first.

• Patient satisfaction

  End of surgery (closure) - 3 months after surgery

Study Arms (2)

Sitting Position

Sitting and semi-sitting

Procedure: Surgical position

Horizontal Position

Prone, lateral and park bench.

Interventions

Surgical position PROCEDURE

Sitting Position

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Ohio State University: lead
• Burdenko Neurosurgery Institute: collaborator

Related Publications (1)

• 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.

  PMID: 32232048 DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sergio Bergese, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: December 6, 2017
• Study Start: October 1, 2015
• Primary Completion: April 23, 2019
• Study Completion: April 23, 2019
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share