Ventilation With High Oxygen Content and Postoperative Pneumocephalus
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|ClinicalTrials.gov Identifier: NCT02722928|
Recruitment Status : Terminated (Variability of the pneumocephalus volume mean was higher than initially assumed)
First Posted : March 30, 2016
Results First Posted : June 4, 2019
Last Update Posted : June 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pneumocephalus||Other: Controlled Ventilation with 100% oxygen||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Impact of Intraoperative Ventilation With High Oxygen Content to Reduce the Incidence and Extent of Postoperative Pneumocephalus in Patients Undergoing Craniotomies|
|Study Start Date :||August 2015|
|Actual Primary Completion Date :||January 2018|
|Actual Study Completion Date :||December 26, 2018|
No Intervention: Conventional 1:1 oxygen/air gas mixture
80 patients will receive ventilation during the surgery with a 1:1 oxygen / air gas mixture
Experimental: Pure oxygen ventilation
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
Other: Controlled Ventilation with 100% oxygen
Patients in group B will be switched from conventional 1:1 oxygen / air ventilation to 100% oxygen controlled ventilation once tumor resection is completed and hemostasis started. They will inhale 100% oxygen until extubation
Other Name: FiO2 100% after tumor resection
- 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
- 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
- Pneumocephalus Volume and Anterior Fossa Surgery [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722928
|United States, Ohio|
|Department of Anesthesiology - Clinical Research|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Gurneet Sandhu, M.D.||Ohio State University|