PneumocephalusNCT02722928
Ventilation With High Oxygen Content and Postoperative Pneumocephalus
A study of Pneumocephalus, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumocephalus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 26 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 18 years of both sexes undergoing surgical procedures to treat hemispheric or posterior cranial fossa tumors and consenting to the study
Who cannot join
- History of severe cardio-pulmonary disease.
- Bleeding disorders
- Previous neurosurgeries requiring cranial reconstruction
- Head trauma
- Decreased consciousness related to cerebral edema
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Anesthesiology - Clinical Research
Columbus, Ohio, 43210
About this study
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.
Read the 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.
- Conditions
- Pneumocephalus
- Being tested
- Controlled Ventilation with 100% oxygen
- Keywords
- Postoperative pneumocephalus, Fraction of inspired oxygen, Intracranial surgery
- Medical subject headings
- Pneumocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled Ventilation with 100% oxygenOther
Also called FiO2 100% after tumor resection
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Controlled Ventilation with 100% oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: One to six hours after surgery
Secondary outcomes (3)
Pneumocephalus Volume and Anterior Fossa Surgery
To compare the presence of postoperative pneumocephalus in patients who underwent anterior fossa surgery.
Measured: One to six hours after surgery
Pneumocephalus Volume and Posterior Fossa Surgery
Pneumocephalus volume in patients who underwent posterior fossa surgery
Measured: 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
Measured: preoperative to postoperative day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startAug 2015
- Primary completionJan 2018
- Study completion26 Dec 2018
Why it stopped: Variability of the pneumocephalus volume mean was higher than initially assumed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PneumocephalusStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gurneet Sandhu, Ohio State University
- Investigators
- Gurneet Sandhu, M.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722928
- Sponsor's protocol ID
- 2015H0032
- Status last verified
- Jun 2019
- First submitted
- 21 Mar 2016
- Last updated
- 4 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16483713Schirmer 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.
PubMed 20405340Gore 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.
PubMed 18447708Aoki 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.
PubMed 8434516Branger 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.
PubMed 11160058Sandhu 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.
PubMed 30784332
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intraoperative Ventilation With High Oxygen Content to Reduce the Incidence and Extent of Postoperative Pneumocephalus in Patients Undergoing Craniotomies
- ClinicalTrials.gov ID
- NCT02722928
- Acronym / sponsor ID
- 2015H0032
- Conditions
- Pneumocephalus
- Keywords
- Postoperative pneumocephalus, Fraction of inspired oxygen, Intracranial surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Variability of the pneumocephalus volume mean was higher than initially assumed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jan 2018 (actual)
- Study completion
- 26 Dec 2018 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Posted 4 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Controlled Ventilation with 100% oxygenPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients > 18 years of both sexes undergoing surgical procedures to treat hemispheric or posterior cranial fossa tumors and consenting to the study
Key exclusion criteria (5 listed)
- History of severe cardio-pulmonary disease.
- Bleeding disorders
- Previous neurosurgeries requiring cranial reconstruction
- Head trauma
- Decreased consciousness related to cerebral edema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controlled Ventilation with 100% oxygenAlso: FiO2 100% after tumor resectionPatients 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 | Pure oxygen ventilation |
Primary outcome
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
3 secondary outcomes
Pneumocephalus Volume and Anterior Fossa Surgery
Time frame: One to six hours after surgery
Pneumocephalus Volume and Posterior Fossa Surgery
Time frame: one to six hours after surgery
Changes in Neurological Outcomes at POD 3 Compared to Preoperative Evaluation
Time frame: preoperative to postoperative day 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16483713Beppu 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.
- Background: PubMed 20405340Schirmer 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.
- Background: PubMed 18447708Gore 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.
- Background: PubMed 8434516Aoki 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.
- Background: PubMed 11160058Branger 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.
- Derived from this study: PubMed 30784332Sandhu 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gurneet Sandhu, M.D. principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Pneumocephalus, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of Postoperative Pneumocephalus (time frame: One to six hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02722928, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.