NCT04530435

PEP Flute-selfcare in COVID-19

PEP Flute-selfcare to Prevent Respiratory Deterioration and Hospitalization Among COVID-19 Patients: a Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 378 (actual)
• Sponsor: Bispebjerg Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Most research on the coronavirus SARS-CoV-2 and COVID-19 disease relate to screening measures, development of vaccines and optimising treatment of hospitalised patients. It is likely that this pandemic will be ongoing for several years until a high level of immunity is reached in the population or a vaccine has been developed. Thus, there is a need of measures to help the SARS-CoV-2 infected individual at home to overcome the course of disease with less symptoms and strain. A Positive Expiratory Pressure (PEP) flute is feasible for home use and it is possible that regular use of PEP flute may prevent the progression of respiratory symptoms in non-hospitalized individuals with COVID-19 disease. The primary objective of the study is to examine the effect of PEP flute use among SARS-CoV-2 infected, non-hospitalized patients on self-reported change in COPD Assessment Test (CAT) score during 30 days of follow-up. The secondary objectives are to compare the development in hospitalization rates and use of antibiotics in the intervention group and the control group during the follow-up period.

Detailed description

It is hypothesized that the PEP flute has positive effects on SARS-CoV-2 infected individual's self-reported respiratory symptoms such as dyspnoea, coughing and perceived mucus clearance through beneficial effects on lung function and airway clearance. Furthermore, the investigators expect a lower rate of hospitalization and use of antibiotics in the intervention group as compared to the control group. Finally, potential subgroup effects by gender, age, comorbidity and BMI at study entry will be explored for all outcomes. Based upon a sample size estimation the investigators assess that inclusion of 200 participants in each intervention arm will be an adequate number. Based on the present testing strategy and COVID-19 incidence, current expectations are that two months should be enough to recruit 400 patients. The investigators will allow for recruitment to the end of December 2020, but will terminate enrolment at n = 400. Link to detailed protocol paper will be added once published.

Conditions

• COVID-19
• SARS-CoV-2

Interventions

Type	Name	Description
DEVICE	PEP flute	Participants are advised to use a PEP flute at least three times daily at an appropriate resistance. Ideally, each session consists of 15 breaths (for approximately 1 minute) repeated twice at an upright position.

Timeline

• Start date: 2020-10-06
• Primary completion: 2021-03-29
• Completion: 2021-09-01
• First posted: 2020-08-28
• Last updated: 2022-03-22

Locations

1 site across 1 country: Denmark