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

Not Applicable

• Conditions: Oximetry; Covid19
• Interventions: Device: Digital oximeter monitoring

• Registration Number: NCT04587921
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-22
• Study First Submitted: 2020-08-18
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-13
• Last Update Submitted: 2020-10-13
• Study First Posted: 2020-10-14
• Last Update Posted: 2020-10-14
• Primary Completion: 2021-01-22
• Study Completion: 2021-06-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients monitored with oximeter	Digital oximeter monitoring	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.

Primary Outcome Measures

Name	Time	Method
Hypoxic alarm	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	6 months	Determination of the number of valid versus not valid or missed measurements of each participant.
Hypoxic burden	6 months	Time spent with SpO2\< 93%, 90% and 85%
Satisfaction of the nursing, medical team and patients with the implemented system	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 Outcome Measures

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

Trial Locations

Locations (1)

Fundação Zerbini - Instituto do Coração (InCor); 🇧🇷 São Paulo, SP, Brazil