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Variability of the pneumocephalus volume mean was higher than initially assumed
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional 1:1 oxygen/air gas mixture | No Intervention | 80 patients will receive ventilation during the surgery with a 1:1 oxygen / air gas mixture | |
| Pure oxygen ventilation | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Controlled Ventilation with 100% oxygen | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Volume of Postoperative Pneumocephalus | 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 | One to six hours after surgery |
| Occurrence of Postoperative Pneumocephalus | 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 | One to six hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pneumocephalus Volume and Anterior Fossa Surgery | To compare the presence of postoperative pneumocephalus in patients who underwent anterior fossa surgery. | One to six hours after surgery |
| Pneumocephalus Volume and Posterior Fossa Surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gurneet Sandhu, M.D. | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology - Clinical Research | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16483713 | Background | Beppu T, Ogasawara K, Ogawa A. Alleviation of intracranial air using carbon dioxide gas during intraventricular tumor resection. Clin Neurol Neurosurg. 2006 Oct;108(7):655-60. doi: 10.1016/j.clineuro.2006.01.002. Epub 2006 Feb 14. | |
| 20405340 | Background | Schirmer CM, Heilman CB, Bhardwaj A. Pneumocephalus: case illustrations and review. Neurocrit Care. 2010 Aug;13(1):152-8. doi: 10.1007/s12028-010-9363-0. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional 1:1 Oxygen/Air Gas Mixture | 39 patients received ventilation during the surgery with a 1:1 oxygen / air gas mixture |
| FG001 | Pure Oxygen Ventilation | 31 patients received controlled ventilation with a conventional 1:1 oxygen / air gas mixture during the approach and tumor removal phases. Once tumor resection was completed and hemostasis started, this group of patients was switched to ventilation with pure oxygen (FiO2 = 100%) until extubation |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional 1:1 Oxygen/Air Gas Mixture | 39 patients received ventilation during the surgery with a 1:1 oxygen / air gas mixture |
| BG001 | Pure Oxygen Ventilation | 31 patients received controlled ventilation with a conventional 1:1 oxygen / air gas mixture during the approach and tumor removal phases. Once tumor resection was completed and hemostasis started, this group of patients was switched to ventilation with pure oxygen (FiO2 = 100%) until extubation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Volume of Postoperative Pneumocephalus | 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 | Posted | Median | Inter-Quartile Range | cm^3 | One to six hours after surgery |
|
Adverse events were collected from the surgery start date / time to postoperative day 3
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conventional 1:1 Oxygen/Air Gas Mixture | 39 patients received ventilation during the surgery with a 1:1 oxygen / air gas mixture |
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Sample size calculations were based on published data and resulted in the trial being under-powered. We did not incorporate a second postoperative CT scan to evaluate the changes in pneumocephalus volume during the immediate postoperative period
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Juan Fiorda-Diaz Postdoctoral Researcher | The Ohio State University Wexner Medical Center | 6142933559 | juan.fiorda@osumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2018 | Feb 18, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011007 | Pneumocephalus |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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|
Pneumocephalus volume in patients who underwent posterior fossa surgery
| one to six hours after surgery |
| Changes in Neurological Outcomes at POD 3 Compared to Preoperative Evaluation | 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 | preoperative to postoperative day 3 |
| 18447708 | Background | Gore PA, Maan H, Chang S, Pitt AM, Spetzler RF, Nakaji P. Normobaric oxygen therapy strategies in the treatment of postcraniotomy pneumocephalus. J Neurosurg. 2008 May;108(5):926-9. doi: 10.3171/JNS/2008/108/5/0926. |
| 8434516 | Background | Aoki N, Sakai T. Computed tomography features immediately after replacement of haematoma with oxygen through percutaneous subdural tapping for the treatment of chronic subdural haematoma in adults. Acta Neurochir (Wien). 1993;120(1-2):44-6. doi: 10.1007/BF02001468. |
| 11160058 | Background | Branger AB, Lambertsen CJ, Eckmann DM. Cerebral gas embolism absorption during hyperbaric therapy: theory. J Appl Physiol (1985). 2001 Feb;90(2):593-600. doi: 10.1152/jappl.2001.90.2.593. |
| 30784332 | Derived | Sandhu G, Gonzalez-Zacarias A, Fiorda-Diaz J, Soghomonyan S, Abdel-Rasoul M, Prevedello LM, Uribe AA, Stoicea N, Targonski D, Prevedello DM, Bergese SD. A prospective randomized clinical trial to evaluate the impact of intraoperative ventilation with high oxygen content on the extent of postoperative pneumocephalus in patients undergoing craniotomies. Br J Neurosurg. 2019 Apr;33(2):119-124. doi: 10.1080/02688697.2018.1562031. Epub 2019 Feb 20. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | Kg/m^2 |
|
| American Society of Anesthesiologists Physical Status (ASA PS) | ASA PS classification describes the preoperative clinical status of the patient. ASA PS comprise 6 levels. The last 2 (ASA PS V and VI) are for moribund and brain death patients respectively and therefore, were not included in our patient setting. The following categories were included in our trial: ASA PS I: A normal healthy patient; ASA PS II: A patient with mild systemic disease; ASA PS III: A patient with severe systemic disease; ASA PS IV: A patient with severe systemic disease that is a constant threat to life | Count of Participants | Participants |
|
| Preoperative Diagnosis | Supratentorial lesions are the ones located above the tentorium cerebelli (e.g. cerebral lesions) Infratentorial lesions are the ones located below the tentorium cerebelli (e.g. cerebellar lesions) | Count of Participants | Participants |
|
|
|
| Primary | Occurrence of Postoperative Pneumocephalus | 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 | Posted | Count of Participants | Participants | One to six hours after surgery |
|
|
|
| Secondary | Pneumocephalus Volume and Anterior Fossa Surgery | To compare the presence of postoperative pneumocephalus in patients who underwent anterior fossa surgery. | Posted | Median | Inter-Quartile Range | cm^3 | One to six hours after surgery |
|
|
|
| Secondary | Pneumocephalus Volume and Posterior Fossa Surgery | Pneumocephalus volume in patients who underwent posterior fossa surgery | Posted | Median | Inter-Quartile Range | cm^3 | one to six hours after surgery |
|
|
|
| Secondary | Changes in Neurological Outcomes at POD 3 Compared to Preoperative Evaluation | 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 | Posted | Count of Participants | Participants | preoperative to postoperative day 3 |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | Pure Oxygen Ventilation | 31 patients received controlled ventilation with a conventional 1:1 oxygen / air gas mixture (60% oxygen concentration) during the approach and tumor removal phases. Once tumor resection was completed and hemostasis started, this group of patients was switched to ventilation with pure oxygen (100% oxygen concentration) until extubation | 0 | 31 | 0 | 31 | 0 | 31 |
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| Deterioration from baseline |
|