Ventilation With High Oxygen Content and Postoperative Pneumocephalus
- Conditions
- Pneumocephalus
- Interventions
- Other: Controlled Ventilation with 100% oxygen
- Registration Number
- NCT02722928
- Lead Sponsor
- Ohio State University
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 100
- Patients > 18 years of both sexes undergoing surgical procedures to treat hemispheric or posterior cranial fossa tumors and consenting to the study
- History of severe cardio-pulmonary disease.
- Bleeding disorders
- Previous neurosurgeries requiring cranial reconstruction
- Head trauma
- Decreased consciousness related to cerebral edema
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pure oxygen ventilation Controlled Ventilation with 100% oxygen Patients will receive controlled ventilation with a conventional 1:1 oxygen / air gas mixture (60% oxygen concentration) during the approach and tumor removal phases. Once tumor resection is completed and hemostasis started, this group of patients will be switched to ventilation with 100% (pure) oxygen concentration
- Primary Outcome Measures
Name Time Method Occurrence of Postoperative Pneumocephalus 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 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 Outcome Measures
Name Time Method Pneumocephalus Volume and Anterior Fossa Surgery One to six hours after surgery To compare the presence of postoperative pneumocephalus in patients who underwent anterior fossa surgery.
Pneumocephalus Volume and Posterior Fossa Surgery one to six hours after surgery Pneumocephalus volume in patients who underwent posterior fossa surgery
Changes in Neurological Outcomes at POD 3 Compared to Preoperative Evaluation preoperative to postoperative day 3 Changes in Neurological Outcomes from baseline (preoperative evaluation) were documented based on differences (if any) found between both physical examinations: baseline (before surgery) and postoperative day (POD) 3 neurological exam. Results were reported as "improvement" (partial or total recovery of baseline neurological signs/symptoms), "no changes", and "deterioration" (focal or global neurological deterioration) in comparison with baseline neurological examination
Trial Locations
- Locations (1)
Department of Anesthesiology - Clinical Research
🇺🇸Columbus, Ohio, United States
Department of Anesthesiology - Clinical Research🇺🇸Columbus, Ohio, United States