Is Hypoxemia Driving Outcome in Acute Hypoxemic Respirato... | NCT07708506

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 13, 2026Actual

Primary Completion Date

Jul 29, 2027Estimated

Completion Date

Jul 29, 2027Estimated

First Submitted Date

Jul 13, 2026

First Submission Date that Met QC Criteria

Jul 13, 2026

First Posted Date

Jul 16, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2026

Last Update Posted Date

Jul 17, 2026Actual

Name	Class
Hospital Universitario de Gran Canaria Doctor Negrín	OTHER

Description Module

Brief Summary

Acute hypoxemic respiratory failure (AHRF) is the most common cause of admission in the intensive care units (UCIs) worldwide. The investigators will assess the value of mediation analysis (a statistical method to understand the mechanism or process through which an independent variable influences a dependent variable (prediction of early ICU death) via a mediator variable. This allows researcher to see the "how" and "why" of a causal link, respecting the timing relationships" o "maintaining appropriate time constants in patients with AHRF me, We had a database with 2,000,000 anonymized and dissociated demographics and clinical data from 1,241 patients with AHRF enrolled in our PANDORA cohort (Prevalence AND Outcome of acute Respiratory fAilure) registered with ClinicalTrails.gov (NCT013145974) from 22 Spanish hospitals and funded by the ISCIII. The study was approved by the Ethics Committees for Clinical research of participating hospitals and informed consent was waived based on Spanish legislation for biomedical research (Royal Decrees 1090/2015 and 957/2020). The investigators will use mediation analysis (Baron & Kenny techniques) to clarify the association of extrapulmonary organ dysfunction and hypoxemia in the early prediction of ICU mortality. We will analyze 1,241 patients mechanically ventilated with AHRF at the time of diagnosis, 1,193 with data at 24 hours, and 996 patients with data at 48 hours from a epidemiological study in Spain.

Detailed Description

Background: Acute hypoxemic respiratory failure (AHRF) is the most common cause of admission in the intensive care units (UCIs) worldwide.

Objectives: The investigators will asess the value of mediation analysis (a statistical method to understand the mechanism or process through which an independent variable influences a dependent variable (prediction of early ICU death) via a mediator variable. This allows researcher to see the "how" and "why" of a causal link, respecting the timing relationships" o "maintaining appropriate time constants in patients with AHRF mechanically ventilated.

Methods: The investigators had a database with 2,000,000 anonymized and dissociated demographics and clinical data from 1,241 patients with AHRF enrolled in our PANDORA cohort (Prevalence AND Outcome of acute Respiratory fAilure) from 22 Spanish hospitals and funded by the ISCIII. The study was approved by the Ethics Committees for Clinical research of participating hospitals and informed consent was waived based on Spanish legislation for biomedical research (Royal Decrees 1090/2015 and 957/2020). The investigators will use mediation analysis (Baron & Kenny techniques) to clarify the association of extrapulmonary organ dysfunction and hypoxemia in the early prediction of ICU mortality. The investigators will analyze 1,241 patients mechanically ventilated with AHRF at the time of diagnosis, 1,193 with data at 24 hours, and 996 patients with data at 48 hours from a epidemiological study in Spain.

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Time on admission	The investigators will use 1241 at the time of meeting AHRF (t0)	Diagnostic Test: mediation analysis
Time 24	The investigaotros will use 1193 patients with AHRF, with completed data after 24 hours of mechanical ventilation	Diagnostic Test: mediation analysis
Time 48	The investigaotros will use 996 patients with AHRF with completed data after 48 hours of mechanical ventilation	Diagnostic Test: mediation analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mediation analysis	Diagnostic Test	This allows researcher to see the "how" and "why" of a causal link, respecting the timing relationships" o "maintaining appropriate time constants in patients with AHRF mechanically ventilated.

Measure	Description	Time Frame
Death in the intensive care unit (ICU)	prediction of ICU death	up to 100 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

intubation and mechanical ventilation PaO2/FiO2 ratio < or = 300 mmHg under MV with PEEP > or = 5 cmH2O, and FiO2 > 0r = 0.3

Exclusion Criteria:

Brain death patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Critically ill patients, intubated and mechanically ventilated, with acute hupoxemic respiratory failure (AHRF)

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesia, Hospital Universitario de Cruces		Barakaldo	Vizcaya	48903	Spain
Complejo Hospitalario Universitario de Albacete (ICU)

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases