Pneumocephalus Clinical Trial
Official title:
Impact of Intraoperative Ventilation With High Oxygen Content to Reduce the Incidence and Extent of Postoperative Pneumocephalus in Patients Undergoing Craniotomies
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.
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.
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