Recruiting

Observational Study

Sponsor:

University of Manitoba

Code:

NCT04644341

Conditions

COVID-19

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

cardiovascular and respiratory systems monitoring

Study Details

Brief summary:

To confront the COVID-19 pandemic hospitals need to maximize bed availability and minimize the duration of patients' stay as much as possible. Given the constraints, physicians are neither able to investigate the long-term effects of COVID-19 nor able to optimize extended treatments beyond the hospital. Physicians also do not have time to keep patients mobile and lucid during their hospital stays, resulting in longer recovery periods and further complications for patients. The investigators propose the development of a tele-monitoring solution for the long-term monitoring of COVID-19 survivors. Such a solution will help save significant healthcare costs by reducing the number of plausible future hospitalizations due to patient complications, providing valuable insights to various stakeholders from doctors to policymakers on the long-term effects of COVID-19, and improving patient care and treatment.

Using our team's existing bio-instrumentation technologies and years of experience, the investigators propose to develop a custom-designed miniaturized monitoring system capable of recording pulse oximetry (blood's oxygen level), blood pressure, heart rate and breathing and swallowing sounds. This solution will be non-invasive, easy to implement and will not require an assistant physically present. The system will be augmented by regular videoconferencing sessions with a medical practitioner. The frequency of the connection can be modified depending on the patient's condition and medical history in consultation with our team's physician.

By running the proposed project on a large scale, the expected outcomes will be: 1) collection of reliable and objective information on the long-term impacts of COVID-19, 2) developing an all-in-one technology for future applications, 3) collection of objective and actionable information that can be used to optimize care and treatment plans for patients, 4) better care and treatment for all strata of society regardless of the remoteness of the residence, and 5) improved mental health and recovery of patients.

Conditions

COVID-19

Study ID

NCT04644341

Start date

Jan 15, 2021

Status verified date

Feb, 2021

Completion date

Nov 1, 2021

Anticipated

Primary completion date

Aug 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age >18 years,
  • MoCA > 15
  • Clinically diagnosed with COVID-19 and have had symptoms for a minimum of 5 days
  • Must speak and understand English
  • Must have wifi Internet and an smart phone

Exclusion Criteria:

-

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

COVID survivors

Individuals who were infected by CPVID-19 and recovered.

Interventions

cardiovascular and respiratory systems monitoring

only one group of individuals to observe the impact of COVID-19 on their cardiovascular and respiratory systems in long term.

Primary outcome measure

  • Blood pressure [ Time Frame: Change from baseline Systolic Blood Pressure at 4 months ]
  • Breathing sounds average power [ Time Frame: Change from normal range at baseline and at 4 months ]
  • Risk of aspiration [ Time Frame: Change from normal range at baseline and at 4 months ]
  • SaO2 level [ Time Frame: Change from normal range at baseline and at 4 months ]

Central Contacts and Locations

Central contacts

Locations

University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada

More Information

Sponsor

University of Manitoba

Last update posted

Feb 26, 2021

Last verified

Feb, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2021-02-26.