Ignite Creation Date:
2024-05-06 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05256082
Status:
COMPLETED
Last Update Posted:
2022-07-21
First Post:
2020-11-04
Brief Title:
Impact of Face Masks on 6MWD in Patients With Pulmonary Hypertension
Sponsor:
University Hospital of Cologne
Organization:
University Hospital of Cologne
Study Overview
Official Title:
Impact of Face Masks on the Six Minute Walking Distance in Pulmonary Hypertension Patients During the COVID-19 Pandemic A Prospective Randomized Cross-over Study
Status:
COMPLETED
Status Verified Date:
2022-07
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:
Pulmonary hypertension PH is classified according to the Nice Classification into different etiologies including pulmonary arterial hypertension PAH a disease of the pulmonary arteriolar vasculature Class I and forms of pulmonary hypertension associated with left heart disease Class II lung disease Class III pulmonary artery obstructions including chronic pulmonary embolism Class IV or other less common causes Class V Patients with PH are at risk in the current COVID 19 pandemic
The course of the disease and the prognosis of the patients are assessed on the basis of various parameters and therapy is adapted accordingly In addition to clinical echocardiographic and laboratory examinations cardiopulmonary performance tests such as the 6-minute walking distance 6MWD are of particular significance According to the ESCERS guidelines for PH and the recommendations of the Cologne Consensus Conference exercise performance is a central criterion for prognostication and treatment decisions
During the COVID-19 pandemic hospitals require the constant use of face masks for patients in most cases also during the 6 minute walking test We suspect a performance-reducing effect of face masks thus impacting the results of the 6MWD A systematic error in the assessment of cardiopulmonary performance should be revealed by comparing the results of the 6MWD with and without mask particularly surgical mask and FFP2 mask
The course of the disease and the prognosis of the patients are assessed on the basis of various parameters and therapy is adapted accordingly In addition to clinical echocardiographic and laboratory examinations cardiopulmonary performance tests such as the 6-minute walking distance 6MWD are of particular significance According to the ESCERS guidelines for PH and the recommendations of the Cologne Consensus Conference exercise performance is a central criterion for prognostication and treatment decisions
During the COVID-19 pandemic hospitals require the constant use of face masks for patients in most cases also during the 6 minute walking test We suspect a performance-reducing effect of face masks thus impacting the results of the 6MWD A systematic error in the assessment of cardiopulmonary performance should be revealed by comparing the results of the 6MWD with and without mask particularly surgical mask and FFP2 mask
Detailed Description:
Monocentric prospective randomized cross-over study in approximately 120 patients with PH n60 for surgical face mask versus no mask n60 for FFP2 mask vs no mask to evaluate the impact of face masks on 6MWD Borg dyspnea score and O2 saturation pre- versus post exercise Patients are randomized to perform the test with vs without mask first and then cross over to the respective other condition
The primary endpoint is the intra-individual difference in 6MWD with and without mask analyzed for the whole study group and for surgical mask and FFP2 mask seperately Secondary endpoints include differences in Borg score and O2 saturation
The primary endpoint is the intra-individual difference in 6MWD with and without mask analyzed for the whole study group and for surgical mask and FFP2 mask seperately Secondary endpoints include differences in Borg score and O2 saturation
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UoC Ethics 20-1581-1 | OTHER | University Hospital of Cologne | None |