This trial is active, not recruiting.

Conditions acute lung injury, acute respiratory distress syndrome, neoplasms
Sponsor Grupo de Apoio ao Adolescente e a Crianca com Cancer
Start date January 2011
End date March 2013
Trial size 29 participants
Trial identifier NCT01304654, 0031/11, UTI/IOP 02/11


Identify pediatric oncologic patients with ALI/ARDS at GRAACC/IOP's Pediatric Intensive Care Unit and evaluate the mechanical ventilation practice in these subjects for a 48mo period.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Consecutively admitted patients at GRAACC's PICU with malignancy diagnosis according to IDC-10, in a 24mo consecutive period, under mechanical ventilation for over 24h and with ALI/ARDS criteria, not younger than 29 days or older than 17 years 11 months

Primary Outcomes

Identify pediatric oncologic patients with ALI/ARDS at GRAACC's PICU and evaluate how they are mechanically ventilated
time frame: 2y

Secondary Outcomes

Epidemiologic data about the selected patients
time frame: 28 days

Eligibility Criteria

Male or female participants up to 17 years old.

Inclusion Criteria: - patients admitted at the intensive care unit with diagnosis of acute lung injury or acute respiratory distress syndrome and submitted to mechanical ventilation for over 24h Exclusion Criteria: - mechanical ventilation less than 24h - absence of ALI/ARDS criteria - no neoplasm diagnosis

Additional Information

Official title Practice of Mechanical Ventilation in Pediatric Oncologic Patients Diagnosed With Acute Lung Injury / Acute Respiratory Distress Syndrome
Principal investigator Rodrigo G Arduini, MD
Description Evaluate adequate mechanical ventilation based on protective ventilation protocols for children available so far. Evaluate and describe the subjects. Evaluate the necessity and outcome of rescue therapies (surfactant, prone position, corticosteroids, alveolar recruitment) Obtain data about ALI/ARDS' etiology, mortality rates and predictive factors related to the outcomes (PICU/ hospital discharge or death)
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Grupo de Apoio ao Adolescente e a Crianca com Cancer.