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

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04587921

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oximetry Covid19	Device: Digital oximeter monitoring	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jun 22, 2020

Anticipated Primary Completion Date :

Jan 22, 2021

Anticipated Study Completion Date :

Jun 22, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: Digital oximeter monitoring Digital oximeter and cardiac frequency monitoring.

Arm

Intervention/Treatment

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.

Device: Digital oximeter monitoring

Digital oximeter and cardiac frequency monitoring.

Outcome Measures

Primary Outcome Measures

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%
Hypoxic alarm [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 [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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Over 18 years old
COVID 19 positive or suspected COVID19

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fundação Zerbini - Instituto do Coração (InCor)	São Paulo	SP	Brazil	054039000

Sponsors and Collaborators

University of Sao Paulo General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Geraldo Lorenzi Filho, Associate Professor/PI, University of Sao Paulo General Hospital

ClinicalTrials.gov Identifier:

NCT04587921

Other Study ID Numbers:

5058/20/087

First Posted:

Oct 14, 2020

Last Update Posted:

Oct 14, 2020

Last Verified:

Oct 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Oct 14, 2020