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

NCT04791501 | Unknown

• 1 other identifier: PI201935
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 23

Brief Summary

The present study is aimed to establish the epidemiological characteristics and clinical outcomes of mechanically ventilated children with acute hypoxemic respiratory failure (AHRF), defined as PaO2/FiO2 ≤300 mmHg on PEEP≥5 cmH2O and FiO2≥0.3, admitted in a network of pediatric hospitals in Spain.

Conditions

Acute Respiratory Insufficiency

Keywords

respiratory failure; mechanical ventilation; children

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 ventilation DEVICE

Ventilatory support

Hypoxemic Respiratory Failure

Eligibility Criteria

• Age: 7 Days - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-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.
• Acute episode (within 7 days of a clinical insult)
• On invasive mechanical ventilatory support
• PaO2/FiO2 ≤ 300 mmHg (or SpO2/FiO2 ≤ 264)
• Positive end-expiratory pressure (PEEP) ≥ 5 cmH2O and FiO2 ≥ 0.3.

You may not qualify if:

• Non-invasive respiratory support \*Aged \>16 years or \< 7 days.

Sponsors & Collaborators

• Yolanda Lopez Fernandez: lead
• Hospital Infantil Universitario Niño Jesús, Madrid, Spain: collaborator
• Consorcio Centro de Investigación Biomédica en Red (CIBER): collaborator
• Dr. Negrin University Hospital: collaborator

Study Sites (23)

Cruces University Hospital

Barakaldo, Bizkaia, 48903, Spain

RECRUITING

Complejo Hospitalario Donosti

Donostia / San Sebastian, Gipuzkoa, Spain

RECRUITING

Hospital Universitario

Burgos, Spain

RECRUITING

Hospital Universitario Puerta del Mar

Cadiz, Spain

RECRUITING

Hospital Universitario Reina Sofia

Córdoba, Spain

RECRUITING

Hospital Universitario

Las Palmas de Gran Canaria, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Spain

RECRUITING

Hospital Universitario Gregorio Marañón

Madrid, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Spain

RECRUITING

Hospital Universitario Virgen de la Arrixaca

Madrid, Spain

RECRUITING

Niño Jesús University Hospital

Madrid, Spain

RECRUITING

Hospital Universitario

Málaga, Spain

RECRUITING

Hospital Central de Asturias

Oviedo, Spain

RECRUITING

Hospital Universitario Virgen del Camino

Pamplona, Spain

RECRUITING

Hospital Universitario de Salamanca

Salamanca, Spain

RECRUITING

Hospital Universitario Tenerife

Santa Cruz de Tenerife, Spain

RECRUITING

Hospital Universitario Santiago de Compostela

Santiago de Compostela, Spain

RECRUITING

Hospital Universitario Virgen del Rocio

Seville, Spain

RECRUITING

Hospital Universitario Virgen de la Salud

Toledo, Spain

RECRUITING

Hospital Universitario La fe

Valencia, Spain

NOT YET RECRUITING

Hospital Clinico Universitario

Valladolid, Spain

RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, 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: 22990455 BACKGROUND

• 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 BACKGROUND

• Kopczynska M, Sharif B, Pugh R, Otahal I, Havalda P, Groblewski W, Lynch C, George D, Sutherland J, Pandey M, Jones P, Murdoch M, Hatalyak A, Jones R, Kacmarek RM, Villar J, Szakmany T, On Behalf Of The Pandora-Wales Investigators. Prevalence and Outcomes of Acute Hypoxaemic Respiratory Failure in Wales: The PANDORA-WALES Study. J Clin Med. 2020 Oct 31;9(11):3521. doi: 10.3390/jcm9113521.

  PMID: 33142837 BACKGROUND

• Lopez-Fernandez YM, Martinez-de-Azagra A, Reyes-Dominguez SB, Gomez-Zamora A, Herrera-Castillo L, Coca-Perez A, Parrilla-Parrilla J, Medina A, Garcia-Iniguez JP, Brezmes-Raposo M, Hernandez-Yuste A, Llorente de la Fuente AM, Ibarra de la Rosa I, Leon-Gonzalez JS, Trastoy-Quintela J, Arjona-Villanueva D, Gonzalez-Martin JM, Szakmany T, Villar J; Prevalence AND Outcome of acute hypoxemic Respiratory fAilure in children (PANDORA-CHILD) Network. The Prevalence and Outcome of Acute Hypoxemic Respiratory Failure (PANDORA) Study in Mechanically Ventilated Children: Prospective Multicenter Epidemiology in Spain, 2019-2021. Pediatr Crit Care Med. 2025 Jun 1;26(6):e759-e772. doi: 10.1097/PCC.0000000000003743. Epub 2025 Apr 25.

  PMID: 40277417 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory 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; ameliamartinezdeazgra@gmail.com

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
• Primary Completion: September 30, 2021
• Study Completion: October 30, 2021
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (23)