Prevalence AND Outcome of Acute Hypoxemic Respiratory fAilure in CHILDren (PANDORA-CHILD)
NCT ID: NCT04791501
Last Updated: 2021-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2019-10-01
2021-10-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Mechanical ventilation
Ventilatory support
Interventions
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Mechanical ventilation
Ventilatory support
Eligibility Criteria
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Inclusion Criteria
* 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
7 Days
16 Years
ALL
No
Sponsors
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Hospital Infantil Universitario Niño Jesús, Madrid, Spain
OTHER
Consorcio Centro de Investigación Biomédica en Red (CIBER)
OTHER_GOV
Dr. Negrin University Hospital
OTHER
Yolanda Lopez Fernandez
OTHER
Responsible Party
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Yolanda Lopez Fernandez
Principal Investigator
Principal Investigators
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Jesús Villar Hernández, MD, PhD
Role: STUDY_DIRECTOR
Multidisciplinary Organ Dysfunction Evaluation Research Network (MODERN). Research Unit, hospital universitario dr. negrín, Las Palmas de gran Canaria, Spain.
Locations
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Cruces University Hospital
Barakaldo, Bizkaia, Spain
Complejo Hospitalario Donosti
Donostia / San Sebastian, Gipuzkoa, Spain
Hospital Universitario
Burgos, , Spain
Hospital Universitario Puerta del Mar
Cadiz, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario
Las Palmas de Gran Canaria, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario Virgen de la Arrixaca
Madrid, , Spain
Niño Jesús University Hospital
Madrid, , Spain
Hospital Universitario
Málaga, , Spain
Hospital Central de Asturias
Oviedo, , Spain
Hospital Universitario Virgen del Camino
Pamplona, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Tenerife
Santa Cruz de Tenerife, , Spain
Hospital Universitario Santiago de Compostela
Santiago de Compostela, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Universitario Virgen de la Salud
Toledo, , Spain
Hospital Universitario La fe
Valencia, , Spain
Hospital Clinico Universitario
Valladolid, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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PI201935
Identifier Type: -
Identifier Source: org_study_id
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