Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408363
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-04-18
Brief Title:
Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions
Sponsor:
Hospital Felicio Rocho
Organization:
Hospital Felicio Rocho
Study Overview
Official Title:
Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions A Randomized Controlled Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Middle ear barotrauma represents the predominant complication associated with hyperbaric oxygen therapy manifesting symptoms ranging from otalgia to tympanic membrane perforation Several pressurization protocols have been proposed to reduce the incidence of this trauma but barotrauma is still the main cause of poor adherence to hyperbaric therapy Therefore this study aims to evaluate the effectiveness of serial tubal opening maneuvers to prevent barotrauma in patients undergoing treatment in a hyperbaric chamber
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None