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| Name | Class |
|---|---|
| Universidad Nacional de Colombia | OTHER |
| Fundación Universitaria de Ciencias de la Salud | OTHER |
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This multicenter observational study will evaluate the association between geographic altitude, availability of critical care resources, and clinical outcomes in children with pediatric acute respiratory distress syndrome (PARDS). Data on demographics, physiology, and hospital structure will be collected from PICUs located at different altitudes worldwide. The study aims to identify gaps in PARDS management and provide recommendations adapted to diverse resource settings.
Pediatric acute respiratory distress syndrome (PARDS) is a major cause of admission and mortality in pediatric intensive care units (PICUs). In high-altitude regions, hypoxemia may be exacerbated, complicating diagnostic interpretation and clinical decision-making. At the same time, variability in the availability of advanced resources-such as mechanical ventilation modes, monitoring systems, and trained personnel-could significantly influence outcomes.
This study will prospectively and retrospectively collect clinical, physiological, and institutional data from pediatric cohorts admitted to PICUs situated at different altitudes worldwide. The analysis will explore how altitude and structural resource differences interact with oxygenation and ventilation parameters to affect patient outcomes. The ultimate goal is to generate evidence that supports context-specific guidelines, reduces inequities in critical care delivery, and strengthens pediatric intensive care practices globally.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Altitude PICUs | Children with PARDS admitted to pediatric intensive care units located at altitudes between 0-1500 meters above sea level. |
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| Intermediate Altitude PICUs | Children with PARDS admitted to pediatric intensive care units located at altitudes between 1501-2500 meters above sea level. |
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| High Altitude PICUs | Children with PARDS admitted to pediatric intensive care units located at altitudes between 2501-3500 meters above sea level. |
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| Very High Altitude PICUs | Children with PARDS admitted to pediatric intensive care units located at altitudes above 3500 meters above sea level. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Geographic Altitude | Other | Participants are grouped according to the altitude of the pediatric intensive care unit (PICU) where they are admitted: low altitude (0-1500 m), intermediate altitude (1501-2500 m), high altitude (2501-3500 m), and very high altitude (>3500 m). Altitude is treated as the primary exposure variable. No therapeutic intervention is administered as part of this study. |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital mortality | Proportion of patients with PARDS who die during hospitalization. Mortality is defined as death during the same hospitalization period in which PARDS was diagnosed. | From PICU admission until hospital discharge (up to 90 days) |
| Measure | Description | Time Frame |
|---|---|---|
| New morbidity at hospital discharge | Presence of new functional morbidity measured using Functional Status Score greater than 2. | From PICU admission until hospital discharge (up to 90 days) |
| Ventilator-free days at 28 days. |
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Inclusion Criteria:
Exclusion Criteria:
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Mechanically ventilated children and adolescents (1 month-18 years) admitted to PICUs at different altitudes worldwide, who fulfill PALICC criteria for PARDS within 24 hours before or after intubation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| PABLO VASQUEZ-HOYOS, MD, MSc | Contact | 573187172029 | pablovasquezmd@gmail.com | |
| SEBASTIAN GONZALEZ-DAMBRAUSKAS, MD | Contact | 59899585225 | sgdambrauskas@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Niño Sor Teresa Huarte Tama | Recruiting | Sucre | Chuquisaca Department | Bolivia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40784821 | Result | Tinoco-Solorzano A, Avila-Hilari A, Avellanas-Chavala ML, Montelongo FJ, Velez-Paez J, Nieto Estrada V, Viruez Soto A, Molano Franco D, Castelo Tamayo E, Granda Luna I, Salazar Mendoza A, Mamani Cruz L, Galindo Ayala J, Vasquez-Hoyos P, Maldonado Coronel F, Huanca Payehuanca R, Sanchez Medina JR. Definitions and consensus recommendations on critical care medicine at altitude from the Expert Committee on Critical Care Medicine at altitude of the Pan-American and Iberian Federation of Critical Care Medicine and Intensive Care. Med Intensiva (Engl Ed). 2025 Oct;49(10):502256. doi: 10.1016/j.medine.2025.502256. Epub 2025 Aug 9. | |
| 25647235 |
| Label | URL |
|---|---|
| Related Info | View source |
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Defined as the number of days a patient is alive and free from invasive mechanical ventilation during the first 28 days after initiation of ventilation. Patients who die within 28 days of initiation will be assigned a value of 0. For survivors, ventilator-free days will be calculated as 28 minus the total number of days on invasive mechanical ventilation during this period.
| 28 days after initiation of invasive mechanical ventilation |
| ICU-free days at 28 days. | Defined as the number of days a patient is alive and not admitted to the ICU during the first 28 days after ICU admission. Patients who die within 28 days of ICU admission will be assigned a value of 0. For survivors, ICU-free days will be calculated as 28 minus the total number of days spent in the ICU during this period. | 28 days after ICU admission |
| Hospital del Norte - El Alto | Recruiting | La Paz | La Paz Department | Bolivia |
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| Hospital Daniel Brancamonte | Recruiting | Potosí | Potosí Department | Bolivia |
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| Hospital Regional San Juan de Dios | Recruiting | Tarija | Tarija Department | Bolivia |
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| Clinica Indisa | Recruiting | Santiago | Chile |
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| Hospital Universitario Clinica San Rafael | Recruiting | Bogotá | DC | 110411 | Colombia |
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| Sociedad de Cirugia de Bogota Hospital de San Jose | Recruiting | Bogotá | DC | 110421 | Colombia |
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| Fundación HOMI | Recruiting | Bogotá | DC | 111411 | Colombia |
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| Hospital Militar Central de Bogotá | Recruiting | Bogotá | DC | Colombia |
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| Hospital Santa Clara | Recruiting | Bogotá | DC | Colombia |
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| Hospital Universitario San Ignacio | Recruiting | Bogotá | DC | Colombia |
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| Los Cobos Medical Center | Recruiting | Bogotá | DC | Colombia |
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| Fundacion Hospital Infantil Los Angeles | Recruiting | Pasto | Departamento de Nariño | 520002 | Colombia |
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| Clínica UROS S.A | Recruiting | Neiva | Huila Department | 410010 | Colombia |
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| Fundación Valle de Lili | Not yet recruiting | Cali | Valle del Cauca Department | Colombia |
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| LaCardio | Not yet recruiting | Bogotá | 110131 | Colombia |
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| Hospital de Emergencias Pediatricas | Recruiting | Lima | Lima Province | Peru |
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| Hospital Nacional Adolfo Guevara Velasco | Recruiting | Cusco | Peru |
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| Centro Hospitalario Pereira Rossell | Recruiting | Montevideo | Montevideo Department | 11600 | Uruguay |
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| Círculo Católico | Recruiting | Montevideo | Uruguay |
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| Result |
| Pediatric Acute Lung Injury Consensus Conference Group. Pediatric acute respiratory distress syndrome: consensus recommendations from the Pediatric Acute Lung Injury Consensus Conference. Pediatr Crit Care Med. 2015 Jun;16(5):428-39. doi: 10.1097/PCC.0000000000000350. |
| 39882326 | Result | Molano-Franco D, Masclans Enviz JR, Viruez-Soto A, Gomez M, Rojas H, Beltran E, Nieto V, Aliaga-Raduan F, Iturri P, Arias-Reyes C, Soliz J. Inflammation severity, rather than respiratory failure, is strongly associated with mortality of ARDS patients in high-altitude ICUs. Front Physiol. 2025 Jan 15;15:1520650. doi: 10.3389/fphys.2024.1520650. eCollection 2024. |
| 31582181 | Result | Jibaja M, Ortiz-Ruiz G, Garcia F, Garay-Fernandez M, de Jesus Montelongo F, Martinez J, Viruez JA, Baez-Pravia O, Salazar S, Villacorta-Cordova F, Morales F, Tinoco-Solorzano A, Ibanez Guzman C, Valle Pinheiro B, Zubia-Olaskoaga F, Duenas C, Garcia AL, Cardinal-Fernandez P. Hospital Mortality and Effect of Adjusting PaO2/FiO2 According to Altitude Above the Sea Level in Acclimatized Patients Undergoing Invasive Mechanical Ventilation. A Multicenter Study. Arch Bronconeumol (Engl Ed). 2020 Apr;56(4):218-224. doi: 10.1016/j.arbres.2019.06.024. Epub 2019 Sep 30. English, Spanish. |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D000532 | Altitude Sickness |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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