Trials / Unknown
UnknownNCT04438863
Daily Home Spirometry for Early Detection of Pulmonary Complications in Patients With COVID19
A Descriptive Pilot Study of Daily Home Spirometry for Early Detection of Pulmonary Complications in High Risk Patients With COVID19
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 90 (estimated)
- Sponsor
- Sheba Medical Center · Other Government
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this preliminary study is to describe the potential decline in forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) as measured by home spirometry in high-risk subjects infected with COVID-19. We hypothesize that the magnitude of such a decline in FEV1 and/or FVC may be associated with clinical deterioration and hospitalization. The study will ultimately inform a larger subsequent RCT that will evaluate the efficacy of home spirometry in the early detection (pre respiratory symptoms) of respiratory complications and therefore prompt early medical attention which is a key for improving outcome.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | home spirometry | portable hand-held spirometer to collect and store daily spirometric data (including FVC, FEV1, forced expiratory flow after 25 to 75% of vital capacity has been expelled, and peak flow). |
Timeline
- Start date
- 2020-08-08
- Primary completion
- 2022-01-01
- Completion
- 2022-01-01
- First posted
- 2020-06-19
- Last updated
- 2021-11-29
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT04438863. Inclusion in this directory is not an endorsement.