Respiratory FailureCARPNCT04668313
COVID-19 Advanced Respiratory Physiology (CARP) Study
An observational study of Respiratory Failure and Covid19, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
The anticipated second wave of COVID-19 cases will present healthcare system challenges, including requirement to monitor large numbers of patients for deteriorating respiratory failure. Rising respiratory rate can identify deterioration requiring escalation of care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Failure, Covid19, Biosensor
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Sep 2020to 29 Sep 2021
- How long will I take part?
- 90 Days
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Potential participants with respiratory failure will be identified by the clinical teams in the emergency departments, admissions units, respiratory wards or high dependency units of the study sites. Patient information sheets would be provided to potential participants. Study team will liase with clinical staff to identify potential participants and maintain a screening and recruitment log. Based on this information, a member of the team delivering the trial with appropriate knowledge will assess eligibility against inclusion and exclusion criteria. No additional tests are required to determine eligibility.
Who may be able to join
- Adult patients with respiratory failure of any cause requiring hospital admission, oxygen therapy and routine NEWS-2 physiology observations.
- CARP detailed sub-study Adult patients with respiratory failure who are suitable for opportunistically acquired serial detailed physiology measurements taken alongside routine clinical care by study team.
- CARP follow-up remote-monitoring sub-study Adult patients with respiratory failure who have provided informed consent and have a smartphone to connect to Fitbit and Lenus accounts for postdischarge wearable device data capture.
Who cannot join
- Exclusion criteria • Lack of capacity or inability to comprehend informed consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
NHS Greater Glasgow and Clyde
Glasgow, G12 0XH
Jacqueline Anderson, Jacqueline.Anderson@ggc.scot.nhs.uk
About this study
The anticipated second wave of COVID-19 cases will present healthcare system challenges, including requirement to monitor large numbers of patients for deteriorating respiratory failure. Rising respiratory rate can identify deterioration requiring escalation of care. However constant monitoring of respiratory rate can be challenging outwith critical care units due to feasibility and inaccuracy of intermittent measurements.
Wearable biosensors which allows for remote patient monitoring of RR is therefore attractive, particularly when combined in a dashboard with clinical summary data. This would establish source data and infrastructure for the training and validation of machine-learning models, with decision support risk-predictions prioritising alerts and clinician reviews.
Read the detailed description
Altair medical has developed a pre-commercial investigational wearable (chest-worn) biosensor which can measure continuous respiratory rate and respiratory events. This sensor has been verified to have good correlation with reference impedance plethysmography data.
Inclusion criteria:
All inpatients in the QEUH with respiratory failure from any cause.
Exclusion criteria:
Lack of capacity to consent
Physiology data will be correlated with event time-course data including oxygen and breathing support requirements, deterioration, hospital discharge and status at 28 days and 90 days post discharge.
A small subset of patients will have further investigations - parasternal EMG; thoracic electrical impedance tomography; forced oscillometry and post discharge Altair and Fitbit data.
Study analysis will include machine learning model development with the objective of developing risk-predictions for clinically significant deteriorations.
- Conditions
- Respiratory Failure, Covid19, Biosensor
- Medical subject headings
- Respiratory Insufficiency, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Machine-learning model development
Developing risk-predictions for clinically significant deteriorations
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start29 Sep 2020
- Primary completion30 Dec 2020 (estimated)
- Study completion29 Sep 2021 (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
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- Altair Medical, Storm ID
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668313
- Sponsor's protocol ID
- INGN20RM136
- Acronym
- CARP
- Status last verified
- Dec 2020
- First submitted
- 14 Dec 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Advanced Respiratory Physiology (CARP) Study
- ClinicalTrials.gov ID
- NCT04668313
- Acronym / sponsor ID
- CARP / INGN20RM136
- Conditions
- Respiratory Failure, Covid19, Biosensor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- Altair Medical, Storm ID
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 29 Sep 2021 (estimated)
- First posted
- 16 Dec 2020 (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.
The anticipated second wave of COVID-19 cases will present healthcare system challenges, including requirement to monitor large numbers of patients for deteriorating respiratory failure. Rising respiratory rate can identify deterioration requiring escalation of care. However constant monitoring of respiratory rate can be challenging outwith critical care units due to feasibility and inaccuracy of intermittent measurements.
Wearable biosensors which allows for remote patient monitoring of RR is therefore attractive, particularly when combined in a dashboard with clinical summary data. This would establish source data and infrastructure for the training and validation of machine-learning models, with decision support risk-predictions prioritising alerts and clinician reviews.
Detailed description
Altair medical has developed a pre-commercial investigational wearable (chest-worn) biosensor which can measure continuous respiratory rate and respiratory events. This sensor has been verified to have good correlation with reference impedance plethysmography data.
Inclusion criteria:
All inpatients in the QEUH with respiratory failure from any cause.
Exclusion criteria:
Lack of capacity to consent
Physiology data will be correlated with event time-course data including oxygen and breathing support requirements, deterioration, hospital discharge and status at 28 days and 90 days post discharge.
A small subset of patients will have further investigations - parasternal EMG; thoracic electrical impedance tomography; forced oscillometry and post discharge Altair and Fitbit data.
Study analysis will include machine learning model development with the objective of developing risk-predictions for clinically significant deteriorations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Potential participants with respiratory failure will be identified by the clinical teams in the emergency departments, admissions units, respiratory wards or high dependency units of the study sites. Patient information sheets would be provided to potential participants. Study team will liase with clinical staff to identify potential participants and maintain a screening and recruitment log. Based on this information, a member of the team delivering the trial with appropriate knowledge will assess eligibility against inclusion and exclusion criteria. No additional tests are required to determine eligibility.
Key inclusion criteria (3 listed)
Key exclusion criteria (1 listed)
- Exclusion criteria • Lack of capacity or inability to comprehend informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Machine-learning model development
Time frame: 1 year
Developing risk-predictions for clinically significant deteriorations
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Respiratory Failure
Active, not recruitingObservational study
A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.
Nasal Airway Obstruction
Not yet recruitingObservational study
Lactate/Albumin Ratio and Mortality in Respiratory Failure
Acute Respiratory Failure, Critical Illness
RecruitingPhase 3
Phase III Study of HS-10504 Versus Platinum-Based Doublet Chemotherapy in Patients With C797S+ NSCLC
Advanced or Metastatic NSCLC
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Recruiting
Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis
Nasal Airway Obstruction
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 Covid19, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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 3 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 16 Dec 2020. 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 United Kingdom. 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 Chris Carlin (01414516088, Christopher.Carlin@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Machine-learning model development (time frame: 1 year). 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 16 Dec 2020.