Impact of Intraoperative Ventilation With High Oxygen Content to Reduce the Incidence and Extent of Postoperative Pneumocephalus in Patients Undergoing Craniotomies
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pneumocephalus
- Sponsor
- Ohio State University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Occurrence of Postoperative Pneumocephalus
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
The aim of this study is to compare the incidence and volume of postoperative pneumocephalus in patients receiving ventilation with 100% oxygen during the last stage of surgery versus a conventional 1:1 oxygen/air gas mixture.
Detailed Description
Background: Postoperative pneumocephalus is a common complication in patients undergoing craniotomies. Even though the treatment of postoperative pneumocephalus with the use of supplemental oxygen is well documented, yet not reports have shown its role for the prevention of this condition. We suggest the use of intraoperative ventilation with 100% oxygen as prophylaxis for the incidence and severity of postoperative pneumocephalus in patients undergoing intracranial surgery. Objectives: The aim of this study is to compare the incidence and volume of postoperative pneumocephalus in patients receiving ventilation with 100% oxygen during the last stage of surgery versus a conventional 1:1 oxygen/air gas mixture. Study Methods: A single-blinded, prospective study, randomizing 80 patients per group, expecting 80% power to detect a 20% decrease in pneumocephalus volume for the interventional group. Inclusion criteria: Patients \>18 years, scheduled to undergo elective craniotomy, and be willing to give written informed consent. Study Procedures: Once the tumor resection is completed and hemostasis started (beginning of stage 2), patients will be assigned to receive either 1:1 oxygen/air gas mixture (control group) or 100% oxygen (intervention group) until the end of the surgery. All patients will receive postoperative supplemental oxygen via nasal cannula. CT scan will be performed within 1 to 6 postoperative hours as standard of care. A blinded radiologist will review all CT scans and assess the extent and frequency of postoperative pneumocephalus. Clinical Outcomes: Patients' demographic data, length of stage 2, period of time between the end of surgery and CT scan, and pneumocephalus volumetric measurements will be compared between groups. Baseline neurological status will be compared with clinical and imaging postoperative findings.
Investigators
Gurneet Sandhu
M.D.
Ohio State University
Eligibility Criteria
Inclusion Criteria
- •Patients \> 18 years of both sexes undergoing surgical procedures to treat hemispheric or posterior cranial fossa tumors and consenting to the study
Exclusion Criteria
- •History of severe cardio-pulmonary disease.
- •Bleeding disorders
- •Previous neurosurgeries requiring cranial reconstruction
- •Head trauma
- •Decreased consciousness related to cerebral edema
Outcomes
Primary Outcomes
Occurrence of Postoperative Pneumocephalus
Time Frame: One to six hours after surgery
Compare the occurrence rate of postoperative pneumocephalus (present or not present) in patients receiving intraoperative ventilation with 100% oxygen during hemostasis and wound closure versus 1:1 oxygen / air mixture
Volume of Postoperative Pneumocephalus
Time Frame: One to six hours after surgery
Compare the extent (cm3) of postoperative pneumocephalus in patients ventilated intraoperatively with 100% oxygen during hemostasis and wound closure versus 1:1 oxygen / air mixture
Secondary Outcomes
- Pneumocephalus Volume and Anterior Fossa Surgery(One to six hours after surgery)
- Pneumocephalus Volume and Posterior Fossa Surgery(one to six hours after surgery)
- Changes in Neurological Outcomes at POD 3 Compared to Preoperative Evaluation(preoperative to postoperative day 3)