Ventilation With High Oxygen Content and Postoperative Pneumocephalus

Pneumocephalus Clinical Trial

Official title:

Impact of Intraoperative Ventilation With High Oxygen Content to Reduce the Incidence and Extent of Postoperative Pneumocephalus in Patients Undergoing Craniotomies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02722928
• Other study ID #: 2015H0032
• Status: Terminated
• Phase: N/A
• Start date: August 2015
• Est. completion date: December 26, 2018

Study information

• Verified date: June 2019
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: December 26, 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumocephalus

Intervention

Other:
• Controlled 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

Locations

Country	Name	City	State
United States	Department of Anesthesiology - Clinical Research	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. Epub 2006 Feb 14. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	One to six hours after surgery
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	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.	One to six hours after surgery
Secondary	Pneumocephalus Volume and Posterior Fossa Surgery	Pneumocephalus volume in patients who underwent posterior fossa surgery	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	preoperative to postoperative day 3