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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05384314
Other study ID # RespiraSense ABG investigation
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 12, 2021
Est. completion date December 12, 2022

Study information

Verified date May 2022
Source Beaumont Hospital
Contact Richard Costello
Phone +353(0)18093000
Email rcostello@rcsi.ie
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 322
Est. completion date December 12, 2022
Est. primary completion date October 12, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Respiratory condition is the primary admission diagnosis Exclusion Criteria: - Pregnant patients in their 2nd or 3rd trimester

Study Design


Intervention

Device:
RespiraSense
The use of continuous electronic monitoring of respiratory rate

Locations

Country Name City State
Ireland Beaumont Hospital Dublin

Sponsors (1)

Lead Sponsor Collaborator
Beaumont Hospital

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Other PPV of elevated RR PPV of elevated RR (for each of i. and ii. above) for requirement of a meaningful intervention 6 months
Primary Positive Predictive Value/Precision (PPV) 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 PPV of an elevated RR for an abnormal ABG - for a mix of disease states PPV of an elevated RR for an abnormal ABG - for a mix of disease states, all of which fall under Respiratory Failure 12 months
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