A Retrospective Study to Evaluate the Predictability of Abnormal Arterial Blood Gas Measurements Through Novel Observations of Continuous Trends in Electronically Measured Respiratory Rate in a Mixed Cohort of Respiratory Compromised Patients

May 19, 2022 updated by: Professor Richard Costello, Beaumont Hospital
A retrospective study to evaluate the predictability of abnormal arterial blood gas measurements through novel observations of continuous trends in electronically measured respiratory in a mixed cohort of respiratory compromised patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

322

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Acutely admitted respiratory compromised patients in a hospital setting

Description

Inclusion Criteria:

  • Respiratory condition is the primary admission diagnosis

Exclusion Criteria:

  • Pregnant patients in their 2nd or 3rd trimester

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COPD
Patients admitted with COPD as the primary admission.
Device: RespiraSense
The use of continuous electronic monitoring of respiratory rate
Respiratory Compromised General
Patients admitted with Pneumonia, COPD, COVID, to be included
Device: RespiraSense
The use of continuous electronic monitoring of respiratory rate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive Predictive Value/Precision (PPV)
Time Frame: 12 months
Positive Predictive Value/Precision (PPV) of an elevated RespiraSense monitoring Respiratory Rate (RR) for an abnormal ABG - for a single disease state (COPD)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PPV of an elevated RR for an abnormal ABG - for a mix of disease states
Time Frame: 12 months
PPV of an elevated RR for an abnormal ABG - for a mix of disease states, all of which fall under Respiratory Failure
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
PPV of elevated RR
Time Frame: 6 months
PPV of elevated RR (for each of i. and ii. above) for requirement of a meaningful intervention
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beaumont Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2021

Primary Completion (Anticipated)

October 12, 2022

Study Completion (Anticipated)

December 12, 2022

Study Registration Dates

First Submitted

May 17, 2022

First Submitted That Met QC Criteria

May 19, 2022

First Posted (Actual)

May 20, 2022

Study Record Updates

Last Update Posted (Actual)

May 20, 2022

Last Update Submitted That Met QC Criteria

May 19, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RespiraSense ABG investigation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be made available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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