Acute Hypoxemic Respiratory FailureCOVIDOMICSNCT06695442
Predictive Model for High-Flow Nasal Cannula Failure in COVID-19-related Acute Hypoxemic Respiratory Failure Based on Metabolomics and Clinical Data
An observational study of Acute Hypoxemic Respiratory Failure and COVID 19, run by Hospital del Mar Research Institute (IMIM) at 1 site in Spain.
Trial summary
The aim of this prospective observational cohort study is to develop a predictive model for high-flow nasal cannula (HFNC) failure in patients with acute hypoxemic respiratory failure (AHRF) caused by SARS-CoV-2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure, COVID 19
- How many people
- 111 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2020to 1 Dec 2021
- How long will I take part?
- 1 Month
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to Hospital del Mar in Barcelona, Spain
Who may be able to join
- Adult patients (≥18 years old) with acute hypoxemic respiratory failure (AHRF) confirmed as secondary to SARS-CoV-2 infection via PCR testing.
- Requirement for high-flow nasal cannula (HFNC) initiated within 48 hours of hospital admission.
Who cannot join
- Patients under the age of 18
- Patients with active "do not resuscitate" (DNR) orders at the time of inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Model for High-Flow Nasal Cannula Failure Based on Metabolomics and Clinical Data: COVID-19 As a Use Case
The aim of this prospective observational cohort study is to develop a predictive model for high-flow nasal cannula (HFNC) failure in patients with acute hypoxemic respiratory failure (AHRF) caused by SARS-CoV-2. By combining clinical data and metabolomic profiles, the study seeks to answer:
- Can integrating clinical parameters with metabolomic markers enhance the prediction of HFNC failure in AHRF patients?
Participants with AHRF due to SARS-CoV-2 receiving HFNC under standard-of-care protocols will be monitored until hospital discharge or death. Blood samples for metabolomic analysis will be collected at inclusion.
Read the detailed description
This prospective observational cohort study focuses on developing and validating a predictive model for HFNC failure in patients with SARS-CoV-2-related AHRF, combining clinical parameters and metabolomic profiling. Patients received standard-of-care therapy based on hospital protocols, with clinical data and plasma samples collected at inclusion (T0) for laboratory and metabolomic analyses.
The study consists of two cohorts: a Training Cohort (March 2020 to April 2021) for model development and a Validation Cohort (May 2021 to October 2021) for model validation and external testing. HFNC outcomes were classified as success or failure, with failure defined as requiring orotracheal intubation (OTI). Advanced machine-learning techniques were employed for feature selection and model optimization, targeting precise integration of clinical and metabolomic data.
This model seeks to enhance early identification of HFNC failure risk, enabling timely interventions and personalized management in critically ill AHRF patients.
- Conditions
- Acute Hypoxemic Respiratory Failure, COVID 19
- Keywords
- Acute Hypoxemic Respiratory Failure, COVID-19, High-Flow Nasal Cannula, Predictive Model, Machine Learning, Metabolomics
- Medical subject headings
- Respiratory Insufficiency, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Training Cohort | Participants included from March 2020 to April 2021 for model development. | |
| Validation Cohort | Participants included from May 2021 to October 2021 for model validation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive Model Development
Area Under the Receiver Operating Characteristic Curve (AUC) of the final predictive model for identifying HFNC failure, measured at the time of study inclusion (T0).
Measured: From the initiation of HFNC until the need for intubation, hospital discharge, or death, whichever occurs first (up to 28 days). Completed using the Training Cohort (March 2020 to April 2021).
Secondary outcomes (2)
Identification of Key Metabolites
Concentrations of key metabolomic markers (e.g., anthranilic acid, octanoic acid) associated with HFNC failure, measured at T0.
Measured: At study inclusion (T0).
Validation of the Predictive Model
Performance of the predictive model in the Validation Cohort. Area Under the Receiver Operating Characteristic Curve (AUC) of the final predictive model for identifying HFNC failure, measured at the time of study inclusion (T0).
Measured: From the initiation of HFNC until the need for intubation, hospital discharge, or death, whichever occurs first (up to 28 days). Completed during the Validation Cohort phase (May to October 2021).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start1 Mar 2020
- Primary completion30 Sep 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypoxemic 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
- 111 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Hospital del Mar Research Institute (IMIM)
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacio La Marató de TV3, Instituto de Salud Carlos III, European Union
- Responsible party
- Principal investigator, Andrea Castellvi, Hospital del Mar
- Investigators
- Óscar J Pozo, PhD, Principal investigator, Hospital del Mar Research Institute (IMIM)Joan Ramon Masclans Enviz, MD, PhD, Principal investigator, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695442
- Sponsor's protocol ID
- 2022/10308/I
- Acronym
- COVIDOMICS
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2024
- Last updated
- 19 Nov 2024
- 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 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Model for High-Flow Nasal Cannula Failure Based on Metabolomics and Clinical Data: COVID-19 As a Use Case
- ClinicalTrials.gov ID
- NCT06695442
- Acronym / sponsor ID
- COVIDOMICS / 2022/10308/I
- Conditions
- Acute Hypoxemic Respiratory Failure, COVID 19
- Keywords
- Acute Hypoxemic Respiratory Failure, COVID-19, High-Flow Nasal Cannula, Predictive Model, Machine Learning, Metabolomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Hospital del Mar Research Institute (IMIM)University, hospital or other
- Collaborators
- Fundacio La Marató de TV3, Instituto de Salud Carlos III, European Union
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 19 Nov 2024 (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 aim of this prospective observational cohort study is to develop a predictive model for high-flow nasal cannula (HFNC) failure in patients with acute hypoxemic respiratory failure (AHRF) caused by SARS-CoV-2. By combining clinical data and metabolomic profiles, the study seeks to answer:
- Can integrating clinical parameters with metabolomic markers enhance the prediction of HFNC failure in AHRF patients?
Participants with AHRF due to SARS-CoV-2 receiving HFNC under standard-of-care protocols will be monitored until hospital discharge or death. Blood samples for metabolomic analysis will be collected at inclusion.
Detailed description
This prospective observational cohort study focuses on developing and validating a predictive model for HFNC failure in patients with SARS-CoV-2-related AHRF, combining clinical parameters and metabolomic profiling. Patients received standard-of-care therapy based on hospital protocols, with clinical data and plasma samples collected at inclusion (T0) for laboratory and metabolomic analyses.
The study consists of two cohorts: a Training Cohort (March 2020 to April 2021) for model development and a Validation Cohort (May 2021 to October 2021) for model validation and external testing. HFNC outcomes were classified as success or failure, with failure defined as requiring orotracheal intubation (OTI). Advanced machine-learning techniques were employed for feature selection and model optimization, targeting precise integration of clinical and metabolomic data.
This model seeks to enhance early identification of HFNC failure risk, enabling timely interventions and personalized management in critically ill AHRF patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Cohort | – | –Participants included from March 2020 to April 2021 for model development. |
| Validation Cohort | – | –Participants included from May 2021 to October 2021 for model validation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to Hospital del Mar in Barcelona, Spain
Key inclusion criteria (2 listed)
- Adult patients (≥18 years old) with acute hypoxemic respiratory failure (AHRF) confirmed as secondary to SARS-CoV-2 infection via PCR testing.
- Requirement for high-flow nasal cannula (HFNC) initiated within 48 hours of hospital admission.
Key exclusion criteria (2 listed)
- Patients under the age of 18
- Patients with active "do not resuscitate" (DNR) orders at the time of inclusion.
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
Predictive Model Development
Time frame: From the initiation of HFNC until the need for intubation, hospital discharge, or death, whichever occurs first (up to 28 days). Completed using the Training Cohort (March 2020 to April 2021).
Area Under the Receiver Operating Characteristic Curve (AUC) of the final predictive model for identifying HFNC failure, measured at the time of study inclusion (T0).
2 secondary outcomes
Identification of Key Metabolites
Time frame: At study inclusion (T0).
Validation of the Predictive Model
Time frame: From the initiation of HFNC until the need for intubation, hospital discharge, or death, whichever occurs first (up to 28 days). Completed during the Validation Cohort phase (May to October 2021).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Óscar J Pozo, PhD principal investigator
Hospital del Mar Research Institute (IMIM)
Joan Ramon Masclans Enviz, MD, PhD principal investigator
Hospital del Mar
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 Acute Hypoxemic Respiratory Failure and COVID 19, run by Hospital del Mar Research Institute (IMIM) at 1 site in Spain.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 19 Nov 2024. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive Model Development (time frame: From the initiation of HFNC until the need for intubation, hospital discharge, or death, whichever occurs first (up to 28 days). Completed using the Training Cohort (March 2020 to April 2021).). 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 19 Nov 2024.