CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 116 enrolled
Drug / intervention
driving pressuredevice
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04419376
NCT04419376N/ACompleted

Driving Pressure and Mortality: in the Pediatric Intensive Care Unit (PICU)

Dr. Behcet Uz Children's Hospital·observational·Posted Jun 5, 2020·Updated Jun 5, 2020

In Brief

An observational study evaluating driving pressure for ARDS, Human and Respiratory Failure. Completed, enrolled 116 participants across 1 site.

Detailed Summary

Respiratory failure is one of the most common causes of both hospitalization and mortality in patients in the pediatric intensive care unit (PICU). Recently, it is recommended to target driving pressure (ΔP) in patients with ARDS to achieve better results with the administration of optimal mechanical ventilation. In many studies, higher ΔP was associated with mortality in adult ARDS patients; non-ARDS patients' studies showing the relationship between driving pressure and mortality are few, but contradictory results have come out. This study aimed to determine whether ΔP was associated with mortality in pediatric patients diagnosed as pARDS and non-pARDS who received mechanical ventilation support due to respiratory failure. Patients who received invasive mechanical ventilation support due to respiratory failure in the pediatric intensive care unit over 1 month and under 18 years were included in our study Driving pressure was significantly associated with an increased risk of mortality among mechanically ventilated both pARDS and non-pARDS patients. Future prospective randomized clinical trials are needed to determine a protocol targeting DP can be developed and defining optimum cutoff values.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 5, 2020
Enrollment StartMar 30, 2018
Primary CompletionApr 1, 2020
Study CompletionApr 15, 2020
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.1 years ago

Interventions

driving pressuredevice

Mechanically ventilated patients (via ETT or trachestomy) were recorded for patients whose ventilation duration lasted at least 24 hours.We divided the patients into two groups by calculating the oxygenation index (OI): \[mean airway pressure(MAP) × fraction of inspired oxygen (FiO2) \]/ partial pressure of oxygen in arterial blood (PaO2) × 100) used in the classification of PALICC, including pARDS and non-pARDS.