EndotyPIng PreHospitAl de Novo Acute hYpoxemic Respiratory Failure

NCT05150483 | Recruiting

• 1 other identifier: 80-1/15.10.2020
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

We attempt to perform dynamic endotyping of critically ill patients presenting in the emergency department with de novo acute hypoxemic respiratory failure (AHRF). We also attempt to identify what clinical, radiological, physiological and biological variables collected early in the course of AHRF correlate with subsequent mortality and/or persistent severe hypoxemia.

Conditions

Acute Hypoxemic Respiratory Failure; Acute Respiratory Distress Syndrome

Keywords

critical illness; intensive care unit; endotypes; phenotypes; emergency department; trajectory; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Identification of dynamic endotypes of acute hypoxemic respiratory failure

  Mutually exclusive subgroups of patients (clusters) characterized by a distinct biological profile that might share mortality risk, clinical course, and/or treatment responsiveness.

  Until death or hospital discharge, assessed up to 28 days following presentation to the emergency department

Secondary Outcomes (7)

• All-cause mortality

  Until death or hospital discharge, assessed up to 28 days following presentation to the emergency department

• Persistent severe hypoxemia

  Until 28 days following presentation to emergency department

• Intensive care unit-free days

  Until 28 days following presentation to emergency department

• Vasopressor-free days

  Until 28 days following presentation to emergency department

• Ventilator-free days

  Until 28 days following presentation to emergency department

Study Arms (1)

Patients with de novo acute hypoxemic respiratory failure

We will consider for inclusion patients presenting in the emergency department with de novo acute hypoxemic respiratory failure (AHRF). De novo AHRF is defined as the requirement of oxygen flow rate of 5 liters per minute or more to maintain SpO2 of 90% or more in a patient who does not receive long term oxygen therapy.

Eligibility Criteria

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

Study Population

Patients presenting in the emergency department with de novo acute hypoxemic respiratory failure

You may qualify if:

• Adult patients (aged \>18 years) presenting in the emergency department
• De novo acute hypoxemic respiratory failure (requiring oxygen flow rate of 5 liters per minute or more to maintain SpO2 of 90% or more)

You may not qualify if:

• Age \<18 years
• Not admitted to the hospital
• Postoperative acute respiratory failure (within one week from surgery)
• Chronic hypoxemic respiratory failure (requiring long term oxygen therapy at home)
• Hypercapnic respiratory failure
• Transferred from another hospital or facility
• Pregnant women
• Admitted to the hospital purely to facilitate comfort care
• Lack of informed consent

Sponsors & Collaborators

• Evangelismos Hospital: lead

Study Sites (1)

Evangelismos Hospital

Athens, Attica, 10676, Greece

RECRUITING

Related Publications (8)

• Meyer NJ, Gattinoni L, Calfee CS. Acute respiratory distress syndrome. Lancet. 2021 Aug 14;398(10300):622-637. doi: 10.1016/S0140-6736(21)00439-6. Epub 2021 Jul 1.

  PMID: 34217425 BACKGROUND

• Beitler JR, Thompson BT, Baron RM, Bastarache JA, Denlinger LC, Esserman L, Gong MN, LaVange LM, Lewis RJ, Marshall JC, Martin TR, McAuley DF, Meyer NJ, Moss M, Reineck LA, Rubin E, Schmidt EP, Standiford TJ, Ware LB, Wong HR, Aggarwal NR, Calfee CS. Advancing precision medicine for acute respiratory distress syndrome. Lancet Respir Med. 2022 Jan;10(1):107-120. doi: 10.1016/S2213-2600(21)00157-0. Epub 2021 Jul 23.

  PMID: 34310901 BACKGROUND

• Gattinoni L, Marini JJ. Isn't it time to abandon ARDS? The COVID-19 lesson. Crit Care. 2021 Sep 6;25(1):326. doi: 10.1186/s13054-021-03748-6. No abstract available.

  PMID: 34488807 BACKGROUND

• Matthay MA, McAuley DF, Ware LB. Clinical trials in acute respiratory distress syndrome: challenges and opportunities. Lancet Respir Med. 2017 Jun;5(6):524-534. doi: 10.1016/S2213-2600(17)30188-1. Epub 2017 May 26.

  PMID: 28664851 BACKGROUND

• Schenck EJ, Oromendia C, Torres LK, Berlin DA, Choi AMK, Siempos II. Rapidly Improving ARDS in Therapeutic Randomized Controlled Trials. Chest. 2019 Mar;155(3):474-482. doi: 10.1016/j.chest.2018.09.031. Epub 2018 Oct 22.

  PMID: 30359616 BACKGROUND

• Sanchez E, Price DR, Chung KP, Oromendia C, Choi AMK, Schenck EJ, Siempos II. Persistent severe acute respiratory distress syndrome for the prognostic enrichment of trials. PLoS One. 2020 Jan 27;15(1):e0227346. doi: 10.1371/journal.pone.0227346. eCollection 2020.

  PMID: 31986174 BACKGROUND

• Harrington JS, Schenck EJ, Oromendia C, Choi AMK, Siempos II. Acute respiratory distress syndrome without identifiable risk factors: A secondary analysis of the ARDS network trials. J Crit Care. 2018 Oct;47:49-54. doi: 10.1016/j.jcrc.2018.06.002. Epub 2018 Jun 2.

  PMID: 29898428 BACKGROUND

• Price DR, Hoffman KL, Oromendia C, Torres LK, Schenck EJ, Choi ME, Choi AMK, Baron RM, Huh JW, Siempos II. Effect of Neutropenic Critical Illness on Development and Prognosis of Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2021 Feb 15;203(4):504-508. doi: 10.1164/rccm.202003-0753LE. No abstract available.

  PMID: 32986956 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Respiratory Insufficiency; Respiratory Distress Syndrome; Critical Illness; Emergencies

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ilias I. Siempos, MD, DSc

  Evangelismos Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eleni D. Papoutsi, MD

CONTACT

+306981173761; helenapapoutsi@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Critical Care and Pulmonary Medicine

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 9, 2021
• Study Start: December 10, 2021
• Primary Completion: March 25, 2026
• Study Completion: April 30, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within 3 months from publication
• Access Criteria: For research use

Locations

GR (1)