Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04654481
Status:
TERMINATED
Last Update Posted:
2022-05-05
First Post:
2020-12-03
Brief Title:
Study of AffloVest in At-Risk Respiratory Patients During COVID-19 Pandemic
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Feasibility of Using a Home-Based High Frequency Chest Wall Oscillation Device AffloVest in At-Risk Respiratory Patients to Decrease Acute Respiratory Care Burden During the COVID-19 Pandemic
Status:
TERMINATED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
only one participant enrolled results will not be provided due to risk of breach of confidentiality
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to investigate the addition of high frequency chest wall oscillation HFCWO therapy to the prescribed care regimen to support the diaphragm during airway clearance among post-COVID patients with COPD and chronic productive cough as a way to limit the advancement of pulmonary symptoms and need for critical services during recovery from COVID-19
Detailed Description:
Thirty study participants in New York City who meet inclusion criteria will be recruited from Mount Sinais COVID-19 Post-Recovery Center of Excellence and Respiratory Institute Fifteen subjects determined by the last digit of their medical record number will receive a HFCWO device AffloVest digital thermometer pulse oximeter and spirometer at their home Participants will be trained remotely to use the AffloVest and spirometer In addition all subjects will be asked to complete a series of online mental health and respiratory symptom assessments via REDCap A 15 patient control group meeting inclusion criteria will be recruited from the Mount Sinai COVID-19 Post-Recovery Center of Excellence and Respiratory Institute using the same screening process This group will not receive the HFCWO intervention but will receive a digital thermometer pulse oximeter and spirometer at their home with training via telehealth asked to complete all REDCap and respiratory symptom assessments Consent for both groups will be obtained by a Mount Sinai clinician-researcher
Study Duration Approximately 30 days plus 60 and 90-day check in
Objectives To investigate the addition of HFCWO therapy to the prescribed care regimen to support the diaphragm during airway clearance among post-COVID patients with COPD and chronic productive cough as a way to limit the advancement of pulmonary symptoms and need for critical services during recovery from COVID-19
Study Duration Approximately 30 days plus 60 and 90-day check in
Objectives To investigate the addition of HFCWO therapy to the prescribed care regimen to support the diaphragm during airway clearance among post-COVID patients with COPD and chronic productive cough as a way to limit the advancement of pulmonary symptoms and need for critical services during recovery from COVID-19
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISMMS-AFF-20 | OTHER | International Biophysics Inc | None |