Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425107
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-09
Brief Title:
Point-of-Care Lung Ultrasound for Prognosis in Critically Ill Infants With Acute Lower Respiratory Tract Infection
Sponsor:
Vittore Buzzi Childrens Hospital
Organization:
Vittore Buzzi Childrens Hospital
Study Overview
Official Title:
Point-of-Care Lung Ultrasound for Prognosis in Critically Ill Infants With Acute Lower Respiratory Tract Infection
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
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:
Bacon-Pocus
Brief Summary:
Prospective observational multicentric study which aims at identifying lung POCUS Point of Care UltraSound findings associated with failure of noninvasive ICU-LRS Intensive Care Unit Level Respiratory Support defined as escalation of settings or need for intubation and invasive mechanical ventilation in infants requiring noninvasive ICU-LRS in the ICU for bronchiolitis and other LRTI Low Respiratory Tract Infection and at identifying lung pleural and diaphragm POCUS findings that are associated with a clinical improvement after escalation of ICU-LRS support by comparing POCUS findings from the first 24 hours of ICU stay to a subsequent study 1 day later
Detailed Description:
Lower respiratory tract infections primarily viral bronchiolitis are a common cause of PICU admission for infants While overall hospitalization rates for bronchiolitis are declining ICU admission rates are actually increasing The trend in respiratory management of critically ill infants with LRTIs has shifted from frequent invasive mechanical ventilation to more common use of non-invasive modalities including CPAP BiPap and HFNC Currently the overwhelming majority of infants requiring ICU-level respiratory support ICU-LRS for bronchiolitis receive only noninvasive support
During the past decade point-of-care lung ultrasound POCUS is increasingly being used in both adults and children to enhance diagnostic and prognostic ability in respiratory failure Lung POCUS is appealing due to the lack of radiation exposure compared to x-rays the added sensitivity and specificity that it can add compared to traditional imaging to help differentiate consolidation from atelectasis from edema may all have similar appearance on x-rays the dynamic nature of the study to evaluate the lung parenchyma pleura and diaphragm and the fact that it can be easily applied and repeated at the bedside to guide adjustments to therapies and evaluate their response Lung POCUS differs from traditional radiology-based lung ultrasound in that it is focused and goal-directed is frequently performed serially by the clinician managing the patient at the bedside and is frequently used to immediately direct care decisions in real-time
While lung POCUS is quickly becoming a standard of care for adults with respiratory failure pediatric data particularly in critically ill infants with bronchiolitis and other lower respiratory tract infections LRTI is largely lacking Investigators from some sites within the BACON research group have begun to evaluate the role of lung POCUS in infants with bronchiolitis These studies have primarily focused on the emergency department but they have identified POCUS findings that are associated with clinical deterioration and have developed a pediatric lung ultrasound score that can predict infants who will require ICU-LRS There are only two pediatric ICU bronchiolitis studies-one looking at the lungpleura but in invasively ventilated patients only and the other focused on the diaphragm in patients requiring noninvasive support
Unfortunately there are minimal data on infants in the ICU with bronchiolitis and all of these prior studies are limited by low sample size Thus there is a significant knowledge gap about the ability of lung POCUS and these previously identified findings and scoring systems to accurately predict failure of noninvasive ICU-LRS for infants in the ICU with bronchiolitis and other LRTIs Furthermore there are no data evaluating the role of lung POCUS in identifying patients who will have a favorable response to adjustments in ICU-LRS settings
Endpoints of the study are
1 To identify lung POCUS findings associated with failure of noninvasive ICU-LRS defined as escalation of settings or need for intubation and invasive mechanical ventilation in infants requiring noninvasive ICU-LRS in the ICU for bronchiolitis and other LRTI
2 To identify lung pleural and diaphragm POCUS findings that are associated with a clinical improvement after escalation of ICU-LRS support by comparing POCUS findings from the first 24 hours of ICU stay to a subsequent study 1 day later
There are no specific safety endpoints for this observational study Families could end participation by their infant at any time and the treating physician or investigator could withdraw the patient from the study but there are no pre-specified safety endpoints
During the past decade point-of-care lung ultrasound POCUS is increasingly being used in both adults and children to enhance diagnostic and prognostic ability in respiratory failure Lung POCUS is appealing due to the lack of radiation exposure compared to x-rays the added sensitivity and specificity that it can add compared to traditional imaging to help differentiate consolidation from atelectasis from edema may all have similar appearance on x-rays the dynamic nature of the study to evaluate the lung parenchyma pleura and diaphragm and the fact that it can be easily applied and repeated at the bedside to guide adjustments to therapies and evaluate their response Lung POCUS differs from traditional radiology-based lung ultrasound in that it is focused and goal-directed is frequently performed serially by the clinician managing the patient at the bedside and is frequently used to immediately direct care decisions in real-time
While lung POCUS is quickly becoming a standard of care for adults with respiratory failure pediatric data particularly in critically ill infants with bronchiolitis and other lower respiratory tract infections LRTI is largely lacking Investigators from some sites within the BACON research group have begun to evaluate the role of lung POCUS in infants with bronchiolitis These studies have primarily focused on the emergency department but they have identified POCUS findings that are associated with clinical deterioration and have developed a pediatric lung ultrasound score that can predict infants who will require ICU-LRS There are only two pediatric ICU bronchiolitis studies-one looking at the lungpleura but in invasively ventilated patients only and the other focused on the diaphragm in patients requiring noninvasive support
Unfortunately there are minimal data on infants in the ICU with bronchiolitis and all of these prior studies are limited by low sample size Thus there is a significant knowledge gap about the ability of lung POCUS and these previously identified findings and scoring systems to accurately predict failure of noninvasive ICU-LRS for infants in the ICU with bronchiolitis and other LRTIs Furthermore there are no data evaluating the role of lung POCUS in identifying patients who will have a favorable response to adjustments in ICU-LRS settings
Endpoints of the study are
1 To identify lung POCUS findings associated with failure of noninvasive ICU-LRS defined as escalation of settings or need for intubation and invasive mechanical ventilation in infants requiring noninvasive ICU-LRS in the ICU for bronchiolitis and other LRTI
2 To identify lung pleural and diaphragm POCUS findings that are associated with a clinical improvement after escalation of ICU-LRS support by comparing POCUS findings from the first 24 hours of ICU stay to a subsequent study 1 day later
There are no specific safety endpoints for this observational study Families could end participation by their infant at any time and the treating physician or investigator could withdraw the patient from the study but there are no pre-specified safety endpoints
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