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

March 8, 2021 updated by: Yolanda Lopez Fernandez

Prevalence and Outcome of Acute Hypoxemic Respiratory Failure in Children.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Prospective, multicenter, observational study focused on the prevalence and outcomes of Acute Hypoxemic Respiratory Failure in children. From a total of 40 pediatric ICUs in Spain, 22 PICUs agreed to participate.

All consecutive patients from 7 days to 16 years old admitted in the PICU will have been enrolled if they fulfilled the following criteria: 1) acute episode (within 7 days of a clinical insult), 2) on invasive mechanical ventilatory support, 3) PaO2/FiO2 ≤ 300 mmHg (or SpO2/FiO2 ≤ 264), 4) Positive end-expiratory pressure (PEEP) ≥ 5 cmH2O and FiO2 ≥ 0.3.

This study is considered an audit, and informed consent is waived.

Period of study: 2 years (October 2019 to September 2021). Recruitment period: two consecutive months (i.e October-November followed by a period of no recruitment) until complete 12 months of recruitment (September 2021).

All investigators have received guidelines outlining the study design and the methods for data collection. All PICU admissions are screened daily for AHRF. Onset of AHRF was defined as the day on which the patient first met all inclusion criteria. All data are collected on standardized forms. Demographics, comorbidities, reason for initiation of IMV, arterial blood gases, laboratory, radiographic, hemodynamic and ventilator data were collected at study entry and during the first three days of AHRF diagnosis (T0 or time of inclusion in the study, 24 hours, days 2 and 3). Chest imaging (chest radiographs, lung ultrasound or computed tomography) were evaluated daily for the presence or absence of infiltrates, atelectasis, acute pulmonary edema, pleural effusion or pneumothorax. Tidal volume (VT) was calculated on the basis of the predicted body weight (PBW). Plateau pressure (Pplat) was determined after the application of a 0.5- to 1.0-sec end-inspiratory hold. Driving pressure was calculated as the difference between Pplat and PEEP. Patients meeting pediatric ARDS criteria were stratified into a mild, moderate, and severe according to PALICC definition and/or berlin definition. All patients are followed until PICU and hospital discharge.

Data are initially collected and stored at each center and then sent to study coordinators at the time of patient's hospital discharge.

Although patient care is not strictly protocolized, physicians are asked to follow the current standards of pediatric critical care management. For ventilatory management, it was recommended that all patients be ventilated with a VT of 6-8 mL/kg PBW, at a ventilatory rate to maintain PaCO2 at 35-50 mm Hg, a Pplat <30 cm H2O, and PEEP and FiO2 combinations to maintain PaO2 >60 mm Hg or SpO2 >90%.

Statistical Analysis: for the main objective of the study, a descriptive analysis including clinical variables, mechanical ventilation data, respiratory settings and ancillary measures will be performed.

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Burgos, Spain
        • Recruiting
        • Hospital Universitario
        • Contact:
        • Principal Investigator:
          • María García, MD
        • Sub-Investigator:
          • Isabel del Blanco, MD
      • Cadiz, Spain
        • Recruiting
        • Hospital Universitario Puerta Del Mar
        • Contact:
        • Principal Investigator:
          • Patricia Rodriguez, MD
        • Sub-Investigator:
          • Lorena Estepa, MD
      • Córdoba, Spain
        • Recruiting
        • Hospital Universitario Reina Sofia
        • Contact:
        • Principal Investigator:
          • Ignacio Ibarra, MD
      • Las Palmas De Gran Canaria, Spain
        • Recruiting
        • Hospital Universitario
        • Contact:
        • Principal Investigator:
          • Rocio Nuñez, MD
        • Sub-Investigator:
          • Sira Alonso, MD
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario 12 de octubre
        • Contact:
        • Principal Investigator:
          • Juan I Sanchez, MD
        • Sub-Investigator:
          • Ana Llorente, MD
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
        • Principal Investigator:
          • Ana Gomez Zamora, MD
        • Sub-Investigator:
          • Pedro de la Oliva, MD, PhD
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Ramón y Cajal
        • Contact:
        • Principal Investigator:
          • Ana Coca, MD
        • Sub-Investigator:
          • Cesar Perez-Caballero, MD
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Gregorio Marañón
        • Contact:
        • Principal Investigator:
          • Laura Herrera, MD
        • Sub-Investigator:
          • Laura Butragueño, MD
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Virgen de la Arrixaca
        • Contact:
        • Principal Investigator:
          • Susana B Reyes, MD, PhD
        • Sub-Investigator:
          • María Miñambres, MD
      • Madrid, Spain
        • Recruiting
        • Niño Jesús University Hospital
        • Contact:
        • Principal Investigator:
          • Amelia Martinez de Azagra, MD
        • Sub-Investigator:
          • Angeles Garcia Teresa, MD
      • Málaga, Spain
        • Recruiting
        • Hospital Universitario
        • Contact:
        • Principal Investigator:
          • Jose M Gonzalez, MD
        • Sub-Investigator:
          • Antonio Morales, MD
      • Oviedo, Spain
        • Recruiting
        • Hospital Central de Asturias
        • Contact:
        • Principal Investigator:
          • Alberto Medina, MD, PhD
        • Sub-Investigator:
          • Juan Mayordomo, MD
      • Pamplona, Spain
        • Recruiting
        • Hospital Universitario Virgen del Camino
        • Contact:
        • Principal Investigator:
          • Mikel Mendizabal, MD
        • Sub-Investigator:
          • María Amores, MD
      • Salamanca, Spain
        • Recruiting
        • Hospital Universitario de Salamanca
        • Contact:
        • Principal Investigator:
          • Francisco Fernández, MD
        • Sub-Investigator:
          • Sira Fernández, MD
      • Santiago De Compostela, Spain
        • Recruiting
        • Hospital Universitario Santiago de Compostela
        • Contact:
        • Principal Investigator:
          • Antonio Rodriguez, MD, PhD
        • Sub-Investigator:
          • Javier Trastoy, MD
      • Sevilla, Spain
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Contact:
        • Principal Investigator:
          • Julio Parrilla, MD
        • Sub-Investigator:
          • Manuel Fernández, MD
      • Tenerife, Spain
        • Recruiting
        • Hospital Universitario Tenerife
        • Contact:
        • Principal Investigator:
          • Luis Perez, MD
        • Sub-Investigator:
          • Jose S Leon, MD
      • Toledo, Spain
        • Recruiting
        • Hospital Universitario Virgen de La Salud
        • Contact:
        • Principal Investigator:
          • David Arjona
        • Sub-Investigator:
          • María J Perez
      • Valencia, Spain
        • Not yet recruiting
        • Hospital Universitario La Fe
        • Contact:
        • Principal Investigator:
          • Vicent Modesto, MD, PhD
      • Valladolid, Spain
        • Recruiting
        • Hospital Clinico Universitario
        • Contact:
        • Principal Investigator:
          • Marta Brezmes, MD
        • Sub-Investigator:
          • Lorena Bermudez, MD
      • Zaragoza, Spain
        • Recruiting
        • Hospital Universitario Miguel Servet
        • Contact:
        • Principal Investigator:
          • Paula Madurga, MD
        • Sub-Investigator:
          • Juan P Iñiguez, MD
    • Bizkaia
      • Barakaldo, Bizkaia, Spain, 48903
        • Recruiting
        • Cruces University Hospital
        • Contact:
        • Principal Investigator:
          • Yolanda M Lopez Fernandez, MD
        • Sub-Investigator:
          • Javier Pilar Orive, MD, PhD
    • Gipuzkoa
      • Donostia, Gipuzkoa, Spain
        • Recruiting
        • Complejo Hospitalario Donosti
        • Contact:
        • Principal Investigator:
          • Eider Oñate, MD, PhD
        • Sub-Investigator:
          • Nerea Ovelar, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Ventilatory support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of hypoxemic acute respiratory failure.
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death in the ICU and in the hospital
Time Frame: through study completion, an average of 60 days
Outcome after discharge from ICU and before discharge to home (overall and in each category of acute hypoxemic respiratory failure).
through study completion, an average of 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yolanda Lopez Fernandez

Collaborators

Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Dr. Negrin University Hospital
Consorcio Centro de Investigación Biomédica en Red, M.P.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2019

Primary Completion (ANTICIPATED)

September 30, 2021

Study Completion (ANTICIPATED)

October 30, 2021

Study Registration Dates

First Submitted

March 2, 2021

First Submitted That Met QC Criteria

March 8, 2021

First Posted (ACTUAL)

March 10, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI201935

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Respiratory Insufficiency

Clinical Trials on Mechanical ventilation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe