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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04419376
Recruitment Status : Completed
First Posted : June 5, 2020
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Ekin soydan, Dr. Behcet Uz Children's Hospital

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.


Condition or disease Intervention/treatment
ARDS, Human Respiratory Failure Device: driving pressure

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Study Type : Observational [Patient Registry]
Actual Enrollment : 116 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Driving Pressure and Mortality: in the Pediatric Intensive Care Unit (PICU)
Actual Study Start Date : March 30, 2018
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : April 15, 2020


Group/Cohort Intervention/treatment
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
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
non-pARDS patients who received mechanical ventilation support due to respiratory failure.
Device: driving pressure
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.




Primary Outcome Measures :
  1. Driving pressure and mortality with all patients [ Time Frame: march 2018-april 2020 ]
    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.


Secondary Outcome Measures :
  1. Driving pressure with mortality in patients with pARDS and non-pARDS patients [ Time Frame: march 2018-april 2020 ]
    we conducted separately to determine the relationship between ΔP and mortality in patients non-ARDS and ARDS


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.


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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04419376


Locations
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Turkey
The Health Sciences University Izmir Behçet Uz Child Health and Diseases education and research hospital
İzmir, Turkey/izmir, Turkey, 35200
Sponsors and Collaborators
Dr. Behcet Uz Children's Hospital
Investigators
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Principal Investigator: ekin soydan Investigator
Publications of Results:

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Responsible Party: Ekin soydan, Principal Investigator, Dr. Behcet Uz Children's Hospital
ClinicalTrials.gov Identifier: NCT04419376    
Other Study ID Numbers: 2019-344
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: we will share our data in the future

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ekin soydan, Dr. Behcet Uz Children's Hospital:
Driving pressure
mortality
Pediatric intensive care unit
Pediatric acute respiratory distress syndrome
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases