Study of AffloVest in At-Risk Respiratory Patients During COVID-19 Pandemic

Mount Sinai Health System

Status: Terminated

Conditions: Chronic Obstructive Pulmonary Disease; Covid19; Chronic Cough

Treatments: Other: Standard Care Plus Monitoring; Device: HCFWO

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04654481

ISMMS-AFF-20 (Other Identifier)

GCO 20-2667

Details and patient eligibility

About

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.

Full description

Thirty study participants in New York City who meet inclusion criteria will be recruited from Mount Sinai's 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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult males and females ≥18 years
• Existing diagnosis of COPD for >6 months
• Chronic productive cough
• Radiographic evidence of flattening of the diaphragm
• Prior COVID-19 diagnosis
• Clinically followed by Mount Sinai COVID-19 Post Recovery and Respiratory Institute.
• Ability to provide informed consent
• Ability to read and fill out survey questionnaires via REDCap (surveys will be available in English and Spanish)
• Access to a home computer, tablet, or smartphone

Exclusion criteria

• Presenting with hypoxia (02 sat <90%)
• Acute COVID-19 infection
• Home oxygen dependent
• Established diagnosis of cystic fibrosis
• History of osteoporosis or rib fracture
• Active Hemoptysis
• Pneumothorax

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1 participants in 2 patient groups

Standard Care Plus Monitoring

Active Comparator group

Description:

All subjects will be monitored via home spirometry, pulse oximetry, temperature checks, telehealth check-in and patient-reported outcome assessments.

Treatment:

Other: Standard Care Plus Monitoring

Standard Care Plus Monitoring and HCFWO

Experimental group

Description:

In addition to home spirometry, pulse oximetry, temperature checks, telehealth check-in and patient-reported outcome assessments, subject will receive an Afflovest device for home use.

Treatment:

Device: HCFWO

Other: Standard Care Plus Monitoring