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

Overview

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.

Full Title of Study: “Feasibility and Impact of Remote Oximetry and Cardiac Frequency Monitoring in Patients Hospitalized and Isolated With Covid-19″

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 22, 2021

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Patients monitored with oximeter
    • The first 45 patients will be monitored but the results will not be displayed. The second half of the patients the oximeter will have their monitoring data available online in the ward.

Clinical Trial Outcome Measures

Primary Measures

  • 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%
  • Hypoxic alarm
    • Time Frame: 6 months
    • Number of times the oximeter record 3 consecutive measurements of SpO2<90%
  • 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 Measures

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

Participating in This Clinical Trial

Inclusion Criteria

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Sao Paulo General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Geraldo Lorenzi Filho, Associate Professor/PI – University of Sao Paulo General Hospital
  • Overall Contact(s)
    • Diego Prieto, Msc, 55 11 994385300, diego.campos.prieto@gmail.com

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