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NCT04587921 Clinical Trial

Feasibility and Impact of Remote Oximetry in Patients Hospitalized With Covid-19

Covid19 Clinical Trial

— MoxiCov  

Official title:
Feasibility and Impact of Remote Oximetry and Cardiac Frequency Monitoring in Patients Hospitalized and Isolated With Covid-19

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04587921
Other study ID # 5058/20/087
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 22, 2020
Est. completion date June 22, 2021

Study information
Verified date October 2020
Source University of Sao Paulo General Hospital
Contact Diego Prieto, Msc
Phone 55 11 994385300
Email diego.campos.prieto@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of MoxiCov is to monitor the oximetry of patients admitted to the Covid nursery to provide a more detailed assistance expecting to reduce the amount of hypoxia in these patients.

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date June 22, 2021
Est. primary completion date January 22, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Over 18 years old

- COVID 19 positive or suspected COVID19

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Digital oximeter monitoring
Digital oximeter and cardiac frequency monitoring.

Locations
Country Name City State
Brazil Fundação Zerbini - Instituto do Coração (InCor) São Paulo SP

Sponsors (1)
Lead Sponsor Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Feasibility of the system: Determination of the number of valid versus not valid or missed measurements Determination of the number of valid versus not valid or missed measurements of each participant. 6 months
Primary Hypoxic burden Time spent with SpO2< 93%, 90% and 85% 6 months
Primary Hypoxic alarm Number of times the oximeter record 3 consecutive measurements of SpO2<90% 6 months
Primary Satisfaction of the nursing, medical team and patients with the implemented system Measurement of NET PROMOTING SCORE (NPS). This score will show the satisfaction of the healthcare team with the device. This score have a minimum of 0 points and maximum of 32 points. 6 months
Secondary Time of SpO2<90%, SpO2<85% and SpO2<80% 6 months
Secondary Number of false alarms caused by malfunctions or bad oximeter positioning 6 months
Secondary Total hospital stay 6 months
Secondary Time of supplementary oxygen use 6 months
Secondary Mortality of participants 6 months
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