NCT05384314

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
322

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2022

Completed
Last Updated

May 20, 2022

Status Verified

May 1, 2022

Enrollment Period

1.3 years

First QC Date

May 17, 2022

Last Update Submit

May 19, 2022

Conditions

Keywords

Respiratory RateArterial Blood Gas

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • PPV of an elevated RR for an abnormal ABG - for a mix of disease states

    12 months

Other Outcomes (1)

  • PPV of elevated RR

    6 months

Study Arms (2)

COPD

Patients admitted with COPD as the primary admission.

Device: RespiraSense

Respiratory Compromised General

Patients admitted with Pneumonia, COPD, COVID, to be included

Device: RespiraSense

Interventions

The use of continuous electronic monitoring of respiratory rate

COPDRespiratory Compromised General

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Acutely admitted respiratory compromised patients in a hospital setting

You may qualify if:

  • Respiratory condition is the primary admission diagnosis

You may not qualify if:

  • Pregnant patients in their 2nd or 3rd trimester

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beaumont Hospital

Dublin, Ireland

RECRUITING

MeSH Terms

Conditions

Respiratory InsufficiencyPulmonary Disease, Chronic ObstructivePneumoniaCommunity-Acquired PneumoniaCOVID-19Lung Diseases

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsCommunity-Acquired InfectionsPneumonia, ViralVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus Infections

Central Study Contacts

Richard Costello

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Respiratory Medicine

Study Record Dates

First Submitted

May 17, 2022

First Posted

May 20, 2022

Study Start

July 12, 2021

Primary Completion

October 12, 2022

Study Completion

December 12, 2022

Last Updated

May 20, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

IPD will not be made available.

Locations