Trials Sponsors Conditions Drugs Pricing

Conditions

Acute Respiratory Insufficiency

Keywords

respiratory failuremechanical ventilationchildren

Outcome Measures

Primary Outcomes (1)

Prevalence of hypoxemic acute respiratory failure.
The investigators will calculate the prevalence in relation to: (i) total number of ICU admissions during the study period in all participating centers; (ii) total number of mechanically ventilated patients during the study period in all participating centers, and (iii) per ICU bed available in the participating centers over the study period.
12 months

Secondary Outcomes (1)

Death in the ICU and in the hospital
through study completion, an average of 60 days

Study Arms (1)

Hypoxemic Respiratory Failure

Consecutive intubated patients receiving invasive mechanical ventilation with a PaO2/FiO2 ≤300 mmHg under a PEEP of 5 cmH2O or more and FiO2 of 0.3 or more.

Device: Mechanical ventilation

Interventions

Mechanical ventilationDevice

Ventilatory support

Hypoxemic Respiratory Failure

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age7 Days - 16 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

Sampling MethodNon-Probability Sample

Study Population

All consecutive patients from 7 days to 16 years old admitted in the PICU with an acute episode (within 7 days of a clinical insult) of hipoxemia defined as PaO2/FiO2 ≤ 300 mmHg (or SpO2/FiO2 ≤ 264), and on invasive mechaniccal ventilatio with a PEEP ≥ 5 cmH2O and FiO2 ≥ 0.3.

You may qualify if:

Patients from 7 days to 16 years old admitted in the PICU.

Sponsors & Collaborators

Hospital Universitario de Gran Canaria Doctor Negrín
Othercollaborator
Yolanda Lopez Fernandez
Otherlead

Study Sites (23)

Cruces University Hospital

Barakaldo, Bizkaia, 48903, Spain

RECRUITING

Yolanda M López-Fernández, MDCONTACT0034946000000 ext. 6582 yolandamarg.lopezfernandez@osakidetza.eus

Yolanda M Lopez Fernandez, MDPRINCIPAL INVESTIGATOR

Javier Pilar Orive, MD, PhDSUB INVESTIGATOR

Complejo Hospitalario Donosti

Donostia / San Sebastian, Gipuzkoa, Spain

RECRUITING

Related Publications (4)

Lopez-Fernandez Y, Azagra AM, de la Oliva P, Modesto V, Sanchez JI, Parrilla J, Arroyo MJ, Reyes SB, Pons-Odena M, Lopez-Herce J, Fernandez RL, Kacmarek RM, Villar J; Pediatric Acute Lung Injury Epidemiology and Natural History (PED-ALIEN) Network. Pediatric Acute Lung Injury Epidemiology and Natural History study: Incidence and outcome of the acute respiratory distress syndrome in children. Crit Care Med. 2012 Dec;40(12):3238-45. doi: 10.1097/CCM.0b013e318260caa3.
PMID: 22990455BACKGROUND
Villar J, Blanco J, Anon JM, Santos-Bouza A, Blanch L, Ambros A, Gandia F, Carriedo D, Mosteiro F, Basaldua S, Fernandez RL, Kacmarek RM; ALIEN Network. The ALIEN study: incidence and outcome of acute respiratory distress syndrome in the era of lung protective ventilation. Intensive Care Med. 2011 Dec;37(12):1932-41. doi: 10.1007/s00134-011-2380-4. Epub 2011 Oct 14.
PMID: 21997128

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory Therapy

Study Officials

Jesús Villar Hernández, MD, PhD
Multidisciplinary Organ Dysfunction Evaluation Research Network (MODERN). Research Unit, hospital universitario dr. negrín, Las Palmas de gran Canaria, Spain.
STUDY DIRECTOR

Central Study Contacts

Yolanda M López-Fernández, MD

CONTACT

0034946006000 yolandamarg.lopezfernandez@osakidetza.eus

Amelia Martinez de Azagra, MD

CONTACT

0034630122450

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 10, 2021

Study Start

October 1, 2019

Actual (reported)

Primary Completion

September 30, 2021

Estimated (date passed)

Prevalence AND Outcome of Acute Hypoxemic Respiratory fAilure in CHILDren (PANDORA-CHILD)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Hypoxemic Respiratory Failure

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (23)

Related Publications (4)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Hypoxemic Respiratory Failure

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (23)

Related Publications (4)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations