Trial Outcomes & Findings for Ventilation With High Oxygen Content and Postoperative Pneumocephalus (NCT NCT02722928)
NCT ID: NCT02722928
Last Updated: 2019-06-04
Results Overview
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
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
One to six hours after surgery
Results posted on
2019-06-04
Participant Flow
Participant milestones
| Measure |
Conventional 1:1 Oxygen/Air Gas Mixture
39 patients received ventilation during the surgery with a 1:1 oxygen / air gas mixture
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
51
|
|
Overall Study
COMPLETED
|
39
|
31
|
|
Overall Study
NOT COMPLETED
|
10
|
20
|
Reasons for withdrawal
| Measure |
Conventional 1:1 Oxygen/Air Gas Mixture
39 patients received ventilation during the surgery with a 1:1 oxygen / air gas mixture
|
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
|
|---|---|---|
|
Overall Study
Standard CT was not as required per prot
|
5
|
13
|
|
Overall Study
Required Intraoperative MRI
|
5
|
7
|
Baseline Characteristics
Ventilation With High Oxygen Content and Postoperative Pneumocephalus
Baseline characteristics by cohort
| Measure |
Conventional 1:1 Oxygen/Air Gas Mixture
n=39 Participants
39 patients received ventilation during the surgery with a 1:1 oxygen / air gas mixture
|
Pure Oxygen Ventilation
n=31 Participants
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
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.69 years
STANDARD_DEVIATION 14.21 • n=5 Participants
|
50.81 years
STANDARD_DEVIATION 13.28 • n=7 Participants
|
48.51 years
STANDARD_DEVIATION 13.86 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
BMI
|
31.35 Kg/m^2
STANDARD_DEVIATION 7.42 • n=5 Participants
|
31.94 Kg/m^2
STANDARD_DEVIATION 6.64 • n=7 Participants
|
31.61 Kg/m^2
STANDARD_DEVIATION 7.04 • n=5 Participants
|
|
American Society of Anesthesiologists Physical Status (ASA PS)
ASA PS I
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
American Society of Anesthesiologists Physical Status (ASA PS)
ASA PS II
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
American Society of Anesthesiologists Physical Status (ASA PS)
ASA PS III
|
26 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
American Society of Anesthesiologists Physical Status (ASA PS)
ASA PS IV
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Preoperative Diagnosis
Supratentorial Lesion (above tentorium cerebelli)
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Preoperative Diagnosis
Infratentorial Lesion (below tentorium cerebelli)
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One to six hours after surgeryCompare the extent (cm3) of postoperative pneumocephalus in patients ventilated intraoperatively with 100% oxygen during hemostasis and wound closure versus 1:1 oxygen / air mixture
Outcome measures
| Measure |
Conventional 1:1 Oxygen/Air Gas Mixture
n=39 Participants
39 patients received ventilation during the surgery with a 1:1 oxygen / air gas mixture
|
Pure Oxygen Ventilation
n=31 Participants
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
|
|---|---|---|
|
Volume of Postoperative Pneumocephalus
|
9.65 cm^3
Interval 3.61 to 23.2
|
7.06 cm^3
Interval 2.7 to 20.1
|
PRIMARY outcome
Timeframe: One to six hours after surgeryCompare 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
Outcome measures
| Measure |
Conventional 1:1 Oxygen/Air Gas Mixture
n=39 Participants
39 patients received ventilation during the surgery with a 1:1 oxygen / air gas mixture
|
Pure Oxygen Ventilation
n=31 Participants
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
|
|---|---|---|
|
Occurrence of Postoperative Pneumocephalus
|
39 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: One to six hours after surgeryTo compare the presence of postoperative pneumocephalus in patients who underwent anterior fossa surgery.
Outcome measures
| Measure |
Conventional 1:1 Oxygen/Air Gas Mixture
n=23 Participants
39 patients received ventilation during the surgery with a 1:1 oxygen / air gas mixture
|
Pure Oxygen Ventilation
n=16 Participants
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
|
|---|---|---|
|
Pneumocephalus Volume and Anterior Fossa Surgery
|
17.4 cm^3
Interval 6.89 to 24.4
|
13.95 cm^3
Interval 4.82 to 22.15
|
SECONDARY outcome
Timeframe: one to six hours after surgeryPneumocephalus volume in patients who underwent posterior fossa surgery
Outcome measures
| Measure |
Conventional 1:1 Oxygen/Air Gas Mixture
n=15 Participants
39 patients received ventilation during the surgery with a 1:1 oxygen / air gas mixture
|
Pure Oxygen Ventilation
n=11 Participants
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
|
|---|---|---|
|
Pneumocephalus Volume and Posterior Fossa Surgery
|
4.38 cm^3
Interval 0.81 to 10.5
|
4.00 cm^3
Interval 0.6 to 13.0
|
SECONDARY outcome
Timeframe: preoperative to postoperative day 3Changes 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
Outcome measures
| Measure |
Conventional 1:1 Oxygen/Air Gas Mixture
n=39 Participants
39 patients received ventilation during the surgery with a 1:1 oxygen / air gas mixture
|
Pure Oxygen Ventilation
n=31 Participants
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
|
|---|---|---|
|
Changes in Neurological Outcomes at POD 3 Compared to Preoperative Evaluation
Improvement from baseline
|
8 Participants
|
6 Participants
|
|
Changes in Neurological Outcomes at POD 3 Compared to Preoperative Evaluation
No changes from baseline
|
25 Participants
|
15 Participants
|
|
Changes in Neurological Outcomes at POD 3 Compared to Preoperative Evaluation
Deterioration from baseline
|
6 Participants
|
10 Participants
|
Adverse Events
Conventional 1:1 Oxygen/Air Gas Mixture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pure Oxygen Ventilation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Juan Fiorda-Diaz Postdoctoral Researcher
The Ohio State University Wexner Medical Center
Phone: 6142933559
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place