Clinical trial NCT02722928: Ventilation With High Oxygen Content and Postoperative Pneumocephalus
Official title: Impact of Intraoperative Ventilation With High Oxygen Content to Reduce the Incidence and Extent of Postoperative Pneumocephalus in Patients Undergoing Craniotomies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pneumocephalus
Keywords: Postoperative pneumocephalus
Fraction of inspired oxygen
Intracranial surgery
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2016-03-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Volume of Postoperative Pneumocephalus
timeFrame: One to six hours after surgery
measure: Occurrence of Postoperative Pneumocephalus
timeFrame: One to six hours after surgery
Secondary outcomes:
measure: Pneumocephalus Volume and Anterior Fossa Surgery
timeFrame: One to six hours after surgery
measure: Pneumocephalus Volume and Posterior Fossa Surgery
timeFrame: one to six hours after surgery
measure: Changes in Neurological Outcomes at POD 3 Compared to Preoperative Evaluation
timeFrame: preoperative to postoperative day 3
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Department of Anesthesiology - Clinical Research
state: Ohio
Study officials:
affiliation: Ohio State University
name: Gurneet Sandhu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.