Predictive Model for High-Flow Nasal Cannula Failure in COVID-19-related Acute Hypoxemic Respiratory Failure Based on Metabolomics and Clinical Data

NCT06695442 | Completed

• 1 other identifier: 2022/10308/I
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acute Hypoxemic Respiratory Failure; COVID 19

Keywords

Acute Hypoxemic Respiratory Failure; COVID-19; High-Flow Nasal Cannula; Predictive Model; Machine Learning; Metabolomics

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  At study inclusion (T0).

• Validation of the Predictive Model

  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).

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to Hospital del Mar in Barcelona, Spain

You may qualify if:

• 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.

You may not qualify if:

• Patients under the age of 18

Sponsors & Collaborators

• Hospital del Mar Research Institute (IMIM): lead
• Fundacio La Marató de TV3: collaborator
• Instituto de Salud Carlos III: collaborator
• European Union: collaborator

Study Sites (1)

Hospital del Mar

Barcelona, Spain, 08003, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma

MeSH Terms

Conditions

Respiratory Insufficiency; COVID-19

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases

Study Officials

• Óscar J Pozo, PhD

  Hospital del Mar Research Institute

  PRINCIPAL INVESTIGATOR

• Joan Ramon Masclans Enviz, MD, PhD

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: March 1, 2020
• Primary Completion: September 30, 2021
• Study Completion: December 1, 2021
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)