Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-24 @ 1:06 PM
NCT ID:
NCT03763461
Brief Summary:
Background: Patients undergoing awake brain surgery are exposed to non-humidified, non-warmed oxygen/air mix flow through a face mask for a prolonged duration. This causes increased discomfort, inadequate breathing with the risk for hypoxia perioperatively. Humidified high flow nasal cannula (HFNC) oxygen therapy potentially improves patient comfort, oxygen/air exchange, improves surgical conditions and prevents atelectasis of the lung, compared to traditional oxygen administration using a face mask in patients undergoing awake brain surgery.
Results of this trial will be used to initiate a more extensive, multicenter trial to further characterize the potential impact of HFNC.
Detailed Description:
Background: Patients undergoing awake brain surgery are exposed to non-humidified, non-warmed oxygen/air mix flow through a face mask for a prolonged duration. This causes increased discomfort, inadequate breathing with the risk for hypoxia perioperatively.
Hypothesis: Humidified high flow nasal cannula (HFNC) oxygen therapy improves patient comfort, oxygen/air exchange, improves surgical conditions and prevents atelectasis of the lung, compared to traditional oxygen administration using a face mask in patients undergoing awake brain surgery.
Methods: After obtaining ethics approval and written informed patient consent, 20 patients undergoing scheduled awake brain surgery will be randomized to either HFNC therapy or standard face mask. Evaluation of patient satisfaction, pain / dry upper airway along with drawing of arterial blood gases to measure oxygen/carbon dioxide content of the blood will be performed during and after the procedure. Lung ultrasound will be performed in the recovery room to determine the presence of atelectasis.
Expected results and Significance: We expect that HFNC improves patient comfort as well as breathing / arterial oxygen content in long-duration awake brain surgery. This could result in higher patient satisfaction, shorter times in PACU, a shorter requirement for oxygen therapy, decreased risk for hypoxia during surgery and better elimination of carbon dioxide - which could lead to better surgical conditions due to softer brain tissue and therefore shorter time for the surgical procedure. Potential positive results of this trial will be used to initiate a more extensive, multicenter trial to further characterize the potential impact of HFNC.
Study:
NCT03763461
Study Brief:
Protocol Section:
NCT03763461