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Clinical Trials/NCT04587921
NCT04587921UnknownNot Applicable

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

University of Sao Paulo General Hospital2 sites in 1 country90 target enrollmentStarted: June 22, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
90
Locations
2
Primary Endpoint
Hypoxic alarm

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Over 18 years old
  • COVID 19 positive or suspected COVID19

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Hypoxic alarm

Time Frame: 6 months

Number of times the oximeter record 3 consecutive measurements of SpO2\<90%

Feasibility of the system: Determination of the number of valid versus not valid or missed measurements

Time Frame: 6 months

Determination of the number of valid versus not valid or missed measurements of each participant.

Hypoxic burden

Time Frame: 6 months

Time spent with SpO2\< 93%, 90% and 85%

Satisfaction of the nursing, medical team and patients with the implemented system

Time Frame: 6 months

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.

Secondary Outcomes

  • Number of false alarms caused by malfunctions or bad oximeter positioning(6 months)
  • Time of SpO2<90%, SpO2<85% and SpO2<80%(6 months)
  • Total hospital stay(6 months)
  • Time of supplementary oxygen use(6 months)
  • Mortality of participants(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Geraldo Lorenzi Filho

Associate Professor/PI

University of Sao Paulo General Hospital

Study Sites (2)

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