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Ventilation With High Oxygen Content and Postoperative Pneumocephalus

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ClinicalTrials.gov Identifier: NCT02722928
Recruitment Status : Terminated (Variability of the pneumocephalus volume mean was higher than initially assumed)
First Posted : March 30, 2016
Results First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Gurneet Sandhu, Ohio State University

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.

Condition or disease Intervention/treatment Phase
Pneumocephalus Other: Controlled Ventilation with 100% oxygen Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Impact of Intraoperative Ventilation With High Oxygen Content to Reduce the Incidence and Extent of Postoperative Pneumocephalus in Patients Undergoing Craniotomies
Study Start Date : August 2015
Actual Primary Completion Date : January 2018
Actual Study Completion Date : December 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
No Intervention: Conventional 1:1 oxygen/air gas mixture
80 patients will receive ventilation during the surgery with a 1:1 oxygen / air gas mixture
Experimental: Pure oxygen ventilation
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
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
Other Name: FiO2 100% after tumor resection




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Pneumocephalus Volume and Anterior Fossa Surgery [ Time Frame: One to six hours after surgery ]
    To compare the presence of postoperative pneumocephalus in patients who underwent anterior fossa surgery.

  2. Pneumocephalus Volume and Posterior Fossa Surgery [ Time Frame: one to six hours after surgery ]
    Pneumocephalus volume in patients who underwent posterior fossa surgery

  3. Changes in Neurological Outcomes at POD 3 Compared to Preoperative Evaluation [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722928


Locations
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United States, Ohio
Department of Anesthesiology - Clinical Research
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: Gurneet Sandhu, M.D. Ohio State University
  Study Documents (Full-Text)

Documents provided by Gurneet Sandhu, Ohio State University:

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gurneet Sandhu, M.D., Ohio State University
ClinicalTrials.gov Identifier: NCT02722928     History of Changes
Other Study ID Numbers: 2015H0032
First Posted: March 30, 2016    Key Record Dates
Results First Posted: June 4, 2019
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gurneet Sandhu, Ohio State University:
Postoperative pneumocephalus
Fraction of inspired oxygen
Intracranial surgery

Additional relevant MeSH terms:
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Pneumocephalus
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries