Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04791501
Status:
UNKNOWN
Last Update Posted:
2021-03-10
First Post:
2021-03-02
Brief Title:
Prevalence AND Outcome of Acute Hypoxemic Respiratory fAilure in CHILDren PANDORA-CHILD
Sponsor:
Yolanda Lopez Fernandez
Organization:
Hospital de Cruces
Study Overview
Official Title:
Prevalence and Outcome of Acute Hypoxemic Respiratory Failure in Children
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PANDORA-child
Brief Summary:
The present study is aimed to establish the epidemiological characteristics and clinical outcomes of mechanically ventilated children with acute hypoxemic respiratory failure AHRF defined as PaO2FiO2 300 mmHg on PEEP5 cmH2O and FiO203 admitted in a network of pediatric hospitals in Spain
Detailed Description:
Prospective multicenter observational study focused on the prevalence and outcomes of Acute Hypoxemic Respiratory Failure in children From a total of 40 pediatric ICUs in Spain 22 PICUs agreed to participate
All consecutive patients from 7 days to 16 years old admitted in the PICU will have been enrolled if they fulfilled the following criteria 1 acute episode within 7 days of a clinical insult 2 on invasive mechanical ventilatory support 3 PaO2FiO2 300 mmHg or SpO2FiO2 264 4 Positive end-expiratory pressure PEEP 5 cmH2O and FiO2 03
This study is considered an audit and informed consent is waived
Period of study 2 years October 2019 to September 2021 Recruitment period two consecutive months ie October-November followed by a period of no recruitment until complete 12 months of recruitment September 2021
All investigators have received guidelines outlining the study design and the methods for data collection All PICU admissions are screened daily for AHRF Onset of AHRF was defined as the day on which the patient first met all inclusion criteria All data are collected on standardized forms Demographics comorbidities reason for initiation of IMV arterial blood gases laboratory radiographic hemodynamic and ventilator data were collected at study entry and during the first three days of AHRF diagnosis T0 or time of inclusion in the study 24 hours days 2 and 3 Chest imaging chest radiographs lung ultrasound or computed tomography were evaluated daily for the presence or absence of infiltrates atelectasis acute pulmonary edema pleural effusion or pneumothorax Tidal volume VT was calculated on the basis of the predicted body weight PBW Plateau pressure Pplat was determined after the application of a 05- to 10-sec end-inspiratory hold Driving pressure was calculated as the difference between Pplat and PEEP Patients meeting pediatric ARDS criteria were stratified into a mild moderate and severe according to PALICC definition andor berlin definition All patients are followed until PICU and hospital discharge
Data are initially collected and stored at each center and then sent to study coordinators at the time of patients hospital discharge
Although patient care is not strictly protocolized physicians are asked to follow the current standards of pediatric critical care management For ventilatory management it was recommended that all patients be ventilated with a VT of 6-8 mLkg PBW at a ventilatory rate to maintain PaCO2 at 35-50 mm Hg a Pplat 30 cm H2O and PEEP and FiO2 combinations to maintain PaO2 60 mm Hg or SpO2 90
Statistical Analysis for the main objective of the study a descriptive analysis including clinical variables mechanical ventilation data respiratory settings and ancillary measures will be performed
All consecutive patients from 7 days to 16 years old admitted in the PICU will have been enrolled if they fulfilled the following criteria 1 acute episode within 7 days of a clinical insult 2 on invasive mechanical ventilatory support 3 PaO2FiO2 300 mmHg or SpO2FiO2 264 4 Positive end-expiratory pressure PEEP 5 cmH2O and FiO2 03
This study is considered an audit and informed consent is waived
Period of study 2 years October 2019 to September 2021 Recruitment period two consecutive months ie October-November followed by a period of no recruitment until complete 12 months of recruitment September 2021
All investigators have received guidelines outlining the study design and the methods for data collection All PICU admissions are screened daily for AHRF Onset of AHRF was defined as the day on which the patient first met all inclusion criteria All data are collected on standardized forms Demographics comorbidities reason for initiation of IMV arterial blood gases laboratory radiographic hemodynamic and ventilator data were collected at study entry and during the first three days of AHRF diagnosis T0 or time of inclusion in the study 24 hours days 2 and 3 Chest imaging chest radiographs lung ultrasound or computed tomography were evaluated daily for the presence or absence of infiltrates atelectasis acute pulmonary edema pleural effusion or pneumothorax Tidal volume VT was calculated on the basis of the predicted body weight PBW Plateau pressure Pplat was determined after the application of a 05- to 10-sec end-inspiratory hold Driving pressure was calculated as the difference between Pplat and PEEP Patients meeting pediatric ARDS criteria were stratified into a mild moderate and severe according to PALICC definition andor berlin definition All patients are followed until PICU and hospital discharge
Data are initially collected and stored at each center and then sent to study coordinators at the time of patients hospital discharge
Although patient care is not strictly protocolized physicians are asked to follow the current standards of pediatric critical care management For ventilatory management it was recommended that all patients be ventilated with a VT of 6-8 mLkg PBW at a ventilatory rate to maintain PaCO2 at 35-50 mm Hg a Pplat 30 cm H2O and PEEP and FiO2 combinations to maintain PaO2 60 mm Hg or SpO2 90
Statistical Analysis for the main objective of the study a descriptive analysis including clinical variables mechanical ventilation data respiratory settings and ancillary measures will be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None