Pneumocephalus
Conditions
Keywords
Postoperative pneumocephalus, Fraction of inspired oxygen, Intracranial surgery
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.
Interventions
OTHERControlled 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
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conventional 1:1 Oxygen/Air Gas Mixture 39 patients received ventilation during the surgery with a 1:1 oxygen / air gas mixture | 39 |
| 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 | 31 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Required Intraoperative MRI | 5 | 7 |
| Overall Study | Standard CT was not as required per prot | 5 | 13 |
Baseline characteristics
| Characteristic | Conventional 1:1 Oxygen/Air Gas Mixture | Total | Pure Oxygen Ventilation |
|---|---|---|---|
| Age, Continuous | 46.69 years STANDARD_DEVIATION 14.21 | 48.51 years STANDARD_DEVIATION 13.86 | 50.81 years STANDARD_DEVIATION 13.28 |
| American Society of Anesthesiologists Physical Status (ASA PS) ASA PS I | 0 Participants | 1 Participants | 1 Participants |
| American Society of Anesthesiologists Physical Status (ASA PS) ASA PS II | 12 Participants | 21 Participants | 9 Participants |
| American Society of Anesthesiologists Physical Status (ASA PS) ASA PS III | 26 Participants | 46 Participants | 20 Participants |
| American Society of Anesthesiologists Physical Status (ASA PS) ASA PS IV | 1 Participants | 2 Participants | 1 Participants |
| BMI | 31.35 Kg/m^2 STANDARD_DEVIATION 7.42 | 31.61 Kg/m^2 STANDARD_DEVIATION 7.04 | 31.94 Kg/m^2 STANDARD_DEVIATION 6.64 |
| Preoperative Diagnosis Infratentorial Lesion (below tentorium cerebelli) | 14 Participants | 24 Participants | 10 Participants |
| Preoperative Diagnosis Supratentorial Lesion (above tentorium cerebelli) | 25 Participants | 46 Participants | 21 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 36 Participants | 63 Participants | 27 Participants |
| Region of Enrollment United States | 39 Participants | 70 Participants | 31 Participants |
| Sex: Female, Male Female | 23 Participants | 37 Participants | 14 Participants |
| Sex: Female, Male Male | 16 Participants | 33 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 31 |
| other Total, other adverse events | 0 / 39 | 0 / 31 |
| serious Total, serious adverse events | 0 / 39 | 0 / 31 |
Outcome results
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
Time frame: One to six hours after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conventional 1:1 Oxygen/Air Gas Mixture | Occurrence of Postoperative Pneumocephalus | 39 Participants |
| Pure Oxygen Ventilation | Occurrence of Postoperative Pneumocephalus | 31 Participants |
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
Time frame: One to six hours after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Conventional 1:1 Oxygen/Air Gas Mixture | Volume of Postoperative Pneumocephalus | 9.65 cm^3 |
| Pure Oxygen Ventilation | Volume of Postoperative Pneumocephalus | 7.06 cm^3 |
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
Time frame: preoperative to postoperative day 3
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Conventional 1:1 Oxygen/Air Gas Mixture | Changes in Neurological Outcomes at POD 3 Compared to Preoperative Evaluation | Improvement from baseline | 8 Participants |
| Conventional 1:1 Oxygen/Air Gas Mixture | Changes in Neurological Outcomes at POD 3 Compared to Preoperative Evaluation | No changes from baseline | 25 Participants |
| Conventional 1:1 Oxygen/Air Gas Mixture | Changes in Neurological Outcomes at POD 3 Compared to Preoperative Evaluation | Deterioration from baseline | 6 Participants |
| Pure Oxygen Ventilation | Changes in Neurological Outcomes at POD 3 Compared to Preoperative Evaluation | Deterioration from baseline | 10 Participants |
| Pure Oxygen Ventilation | Changes in Neurological Outcomes at POD 3 Compared to Preoperative Evaluation | Improvement from baseline | 6 Participants |
| Pure Oxygen Ventilation | Changes in Neurological Outcomes at POD 3 Compared to Preoperative Evaluation | No changes from baseline | 15 Participants |
Secondary
Pneumocephalus Volume and Anterior Fossa Surgery
To compare the presence of postoperative pneumocephalus in patients who underwent anterior fossa surgery.
Time frame: One to six hours after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Conventional 1:1 Oxygen/Air Gas Mixture | Pneumocephalus Volume and Anterior Fossa Surgery | 17.4 cm^3 |
| Pure Oxygen Ventilation | Pneumocephalus Volume and Anterior Fossa Surgery | 13.95 cm^3 |
Secondary
Pneumocephalus Volume and Posterior Fossa Surgery
Pneumocephalus volume in patients who underwent posterior fossa surgery
Time frame: one to six hours after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Conventional 1:1 Oxygen/Air Gas Mixture | Pneumocephalus Volume and Posterior Fossa Surgery | 4.38 cm^3 |
| Pure Oxygen Ventilation | Pneumocephalus Volume and Posterior Fossa Surgery | 4.00 cm^3 |