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

NCT04419376 | Completed

• 1 other identifier: 2019-344
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ARDS, Human; Respiratory Failure

Keywords

Driving pressure; mortality; Pediatric intensive care unit; Pediatric acute respiratory distress syndrome

Outcome Measures

Primary Outcomes (1)

• Driving pressure and mortality with all patients

  Driving pressure and other lung dynamics; according to the type and distribution of the data was compared with chi-square, Wilcoxon, Independent-T-test or Mann-Whitney-U test and p \<0.05 was considered statistically significant.

  march 2018-april 2020

Secondary Outcomes (1)

• Driving pressure with mortality in patients with pARDS and non-pARDS patients

  march 2018-april 2020

Study Arms (2)

Patients with pARDS

Within 7 days of known clinical insult Respiratory failure not fully explained by cardiac failure or fluid overload chest imaging findings of new infiltrate(s) consistent with acute pulmonary parenchymal disease patients with an oxygenation index (OI) (\[FIO2 × mean airway pressure × 100\]/PaO2) above 4

Device: driving pressure

Patients with non-pARDS

non-pARDS patients who received mechanical ventilation support due to respiratory failure.

Device: driving pressure

Interventions

driving pressure DEVICE

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.

Patients with non-pARDS; Patients with pARDS

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

In our study, 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 the study between March 2018 and April 2020. 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 ARDS and non-ARDS.

You may qualify if:

• In our study, patients who received invasive mechanical ventilation support for at least 24 hours due to respiratory failure in the pediatric intensive care unit over 1 month and under 18 years were included in the study between March 2018 and April 2020.

You may not qualify if:

• patients who died within the first 24 hours and patients whose desired respiratory mechanics were not measured and data deficiencies were detected

Sponsors & Collaborators

• Dr. Behcet Uz Children's Hospital: lead

Study Sites (1)

The Health Sciences University Izmir Behçet Uz Child Health and Diseases education and research hospital

Izmir, Turkey/izmir, 35200, Turkey (Türkiye)

Location

Related Publications (28)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

All patients were ventilated with volume control (VCV) or pressure control (PCV) mode during the hospitalization. İn order to measure the driving pressure of patients, Pplat was measured in the mechanical ventilator every 12 hours using an inspiratory hold maneuver. The average Pplat was calculated using the mean of 2 measurements within 24 hours. Then, the total PEEP was measured by expiratory hold maneuver and ΔP was calculated with the Pplat-PEEP formula.

MeSH Terms

Conditions

Respiratory Distress Syndrome; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• ekin soydan

  Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 5, 2020
• Study Start: March 30, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 15, 2020
• Last Updated: June 5, 2020

Record last verified: 2020-06

Locations

TU (1)