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

Primary Purpose

Oximetry, Covid19

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Digital oximeter monitoring

About this trial

This is an interventional supportive care trial for Oximetry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Over 18 years old
COVID 19 positive or suspected COVID19

Sites / Locations

Fundação Zerbini - Instituto do Coração (InCor)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients monitored with oximeter

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Hypoxic burden

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

Hypoxic alarm

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

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.

Secondary Outcome Measures

Time of SpO2<90%, SpO2<85% and SpO2<80%

Number of false alarms caused by malfunctions or bad oximeter positioning

Total hospital stay

Time of supplementary oxygen use

Mortality of participants

Full Information

NCT ID

NCT04587921

First Posted

August 18, 2020

Last Updated

October 13, 2020

Sponsor

University of Sao Paulo General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04587921

Brief Title

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

Acronym

MoxiCov

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

June 22, 2020 (Actual)

Primary Completion Date

January 22, 2021 (Anticipated)

Study Completion Date

June 22, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oximetry, Covid19

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients monitored with oximeter

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Digital oximeter monitoring

Intervention Description

Digital oximeter and cardiac frequency monitoring.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

6 months

Title

Hypoxic burden

Description

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

Time Frame

6 months

Title

Hypoxic alarm

Description

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

Time Frame

6 months

Title

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

Description

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.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Time of SpO2<90%, SpO2<85% and SpO2<80%

Time Frame

6 months

Title

Number of false alarms caused by malfunctions or bad oximeter positioning

Time Frame

6 months

Title

Total hospital stay

Time Frame

6 months

Title

Time of supplementary oxygen use

Time Frame

6 months

Title

Mortality of participants

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Over 18 years old COVID 19 positive or suspected COVID19

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Diego Prieto, Msc

Phone

55 11 994385300

diego.campos.prieto@gmail.com

Facility Information:

Facility Name

Fundação Zerbini - Instituto do Coração (InCor)

City

São Paulo

State/Province

ZIP/Postal Code

054039000

Country

Brazil

Individual Site Status

Recruiting

Facility Contact: