Respiratory FailureNCT05384314
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
An observational study of Respiratory Failure and COPD, run by Beaumont Hospital at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Respiratory Failure, COPD, Pneumonia
- What is being tested?
- RespiraSense
- Type of treatment
- Medical device
- How many people
- 322 participants
- Where
- 1 siteIreland
- Study dates
- 12 Jul 2021to 12 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acutely admitted respiratory compromised patients in a hospital setting
Who may be able to join
- Respiratory condition is the primary admission diagnosis
Who cannot join
- Pregnant patients in their 2nd or 3rd trimester
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Beaumont Hospital
Dublin
Richard W Costello, MD, rcostello@rcsi.ie
About this study
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.
- Conditions
- Respiratory Failure, COPD, Pneumonia, Community-acquired Pneumonia, COVID-19, Pulmonary Disease
- Being tested
- RespiraSense
- Keywords
- Respiratory Rate, Arterial Blood Gas
- Medical subject headings
- Respiratory Insufficiency, Pulmonary Disease, Chronic Obstructive, Pneumonia, Community-Acquired Pneumonia, COVID-19, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RespiraSenseDevice
The use of continuous electronic monitoring of respiratory rate
| Study group | Role | What they receive |
|---|---|---|
| COPD | Patients admitted with COPD as the primary admission. Receives: Device: RespiraSense | |
| Respiratory Compromised General | Patients admitted with Pneumonia, COPD, COVID, to be included Receives: Device: RespiraSense |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Secondary outcomes (1)
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start12 Jul 2021
- Primary completion12 Oct 2022 (estimated)
- Study completion12 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 322 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beaumont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Richard Costello, Beaumont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384314
- Sponsor's protocol ID
- RespiraSense ABG investigation
- Status last verified
- May 2022
- First submitted
- 17 May 2022
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be made available.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05384314
- Acronym / sponsor ID
- RespiraSense ABG investigation
- Conditions
- Respiratory Failure, COPD, Pneumonia, Community-acquired Pneumonia, COVID-19, Pulmonary Disease
- Keywords
- Respiratory Rate, Arterial Blood Gas
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 322 participants (estimated)
- Lead sponsor
- Beaumont HospitalUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 12 Oct 2022 (estimated)
- Study completion
- 12 Dec 2022 (estimated)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD | – | Device: RespiraSensePatients admitted with COPD as the primary admission. |
| Respiratory Compromised General | – | Device: RespiraSensePatients admitted with Pneumonia, COPD, COVID, to be included |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acutely admitted respiratory compromised patients in a hospital setting
Key inclusion criteria (1 listed)
- Respiratory condition is the primary admission diagnosis
Key exclusion criteria (1 listed)
- Pregnant patients in their 2nd or 3rd trimester
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RespiraSenseThe use of continuous electronic monitoring of respiratory rate | Device | COPD, Respiratory Compromised General |
Primary outcome
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)
1 secondary outcome
PPV of an elevated RR for an abnormal ABG - for a mix of disease states
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Individual participant dataSharing planned: No. IPD will not be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure and COPD, run by Beaumont Hospital at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard Costello (+353(0)18093000, rcostello@rcsi.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Predictive Value/Precision (PPV) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.