Altitude and Outcomes in Pediatric ARDS: A Multicenter Study

Официальное название

Evaluation of Altitude as an Independent Risk Factor for Mortality in Pediatric Acute Respiratory Distress Syndrome: Influence of Oxygenation, Ventilation, and Hospital Structure in a Multicenter Observational Study.

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Geographic Altitude
  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.

Первичные конечные точки

• In-hospital mortality [Срок оценки: From PICU admission until hospital discharge (up to 90 days)]

Вторичные конечные точки (3)

• New morbidity at hospital discharge [Срок оценки: From PICU admission until hospital discharge (up to 90 days)]
• Ventilator-free days at 28 days. [Срок оценки: 28 days after initiation of invasive mechanical ventilation]
• ICU-free days at 28 days. [Срок оценки: 28 days after ICU admission]

Критерии участия

Критерии включения

• Age between 1 month (corrected gestational age) and 18 years.
• Admission to a pediatric intensive care unit (PICU) or facility where mechanically ventilated children are cared for.
• Requirement of invasive mechanical ventilation.
• Diagnosis of pediatric acute respiratory distress syndrome (PARDS) according to PALICC criteria, confirmed within 24 hours before or after endotracheal intubation.

Критерии исключения

• Patients with active perinatal lung disease (e.g., neonatal respiratory distress syndrome, pulmonary hemorrhage, persistent pulmonary hypertension of the newborn, early bronchopulmonary dysplasia, meconium aspiration).
• Patients who have received extracorporeal membrane oxygenation (ECMO) prior to or within the first 24 hours of PARDS diagnosis.
• Patients with pre-established limitation of therapeutic effort (LTE) orders or palliative care directives documented before the initiation of invasive mechanical ventilation.
• Readmissions to the PICU during the study period (only the first episode per patient will be included).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Колумбия · 11 центров

• Hospital Universitario Clinica San Rafael — Bogotá
• Sociedad de Cirugia de Bogota Hospital de San Jose — Bogotá
• Fundación HOMI — Bogotá
• Hospital Militar Central de Bogotá — Bogotá
• Hospital Santa Clara — Bogotá
• Hospital Universitario San Ignacio — Bogotá
• Los Cobos Medical Center — Bogotá
• Fundacion Hospital Infantil Los Angeles — Pasto
• … и ещё 3 центра

Bolivia · 4 центра

• Hospital del Niño Sor Teresa Huarte Tama — Sucre
• Hospital del Norte - El Alto — La Paz
• Hospital Daniel Brancamonte — Potosí
• Hospital Regional San Juan de Dios — Tarija

Перу · 2 центра

• Hospital de Emergencias Pediatricas — Lima
• Hospital Nacional Adolfo Guevara Velasco — Cusco

Uruguay · 2 центра

• Centro Hospitalario Pereira Rossell — Montevideo
• Círculo Católico — Montevideo

Чили · 1 центр

• Clinica Indisa — Santiago

Публикации

• 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 Commit PMID 40784821
• 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. PMID 25647235
• 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. PMID 39882326
• 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 Under PMID 31582181

Идентификаторы

NCT: NCT07193771 · LARED-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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