High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation for Congenital Diaphragmatic Hernia
Study Details
Study Description
Brief Summary
The purpose of this study is to conduct a prospective study of all congenital diaphragmatic hernia (CDH) neonates managed at the University of Utah newborn intensive care unit (NICU) and Primary Children's Hospital NICU that required mechanical ventilation at birth. As both high frequency jet ventilation (HFJV) and high frequency oscillatory ventilation (HFOV) are standard approaches to ventilatory support of all neonates including CDH, CDH infants will be randomized at the time of birth or admission to either HFJV or HFOV as initial ventilator mode, stratified by position of the liver in the abdomen or thorax (if known) by 24 hours of age. Measures of oxygenation, ventilation and hemodynamics of the CDH cohort managed on HFOV compared to those on HFJV.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: High Frequency Jet Ventilation (HFJV) with intrathoracic liver Babies known to have the presence of the liver in the intrathoracic space will be placed on the HFJV at delivery or as soon as possible after consent. During analysis, these babies will be compared to babies with intrathoracic liver and randomized to high frequency oscillating ventilator. |
Device: High Frequency Jet Ventilator
HFJV provides short bursts of gas into the respiratory circuit at a rate of 240 to 600/min (4 to 11 Hz) and expiration is passive. It is used in conjunction with a conventional ventilator which provides positive end expiratory pressure (PEEP) and can also provide occasional sigh breaths.
|
| Active Comparator: High Frequency Jet Ventilation (HFJV) without intrathoracic liver Babies who do not have any liver in the intrathoracic space will be placed on the HFJV at delivery or as soon as possible after consent. During analysis, these babies will be compared to babies without intrathoracic liver and randomized to high frequency oscillating ventilator. |
Device: High Frequency Jet Ventilator
HFJV provides short bursts of gas into the respiratory circuit at a rate of 240 to 600/min (4 to 11 Hz) and expiration is passive. It is used in conjunction with a conventional ventilator which provides positive end expiratory pressure (PEEP) and can also provide occasional sigh breaths.
|
| Active Comparator: High Frequency Oscillatory Ventilation (HFOV) with intrathoracic liver Babies known to have the presence of the liver in the intrathoracic space will be placed on the HFOV at delivery or as soon as possible after consent. During analysis, these babies will be compared to babies with intrathoracic liver and randomized to HFJV. |
Device: High Frequency Oscillatory Ventilator
HFOV uses a piston diaphragm to generate alternating positive and negative pressure changes to give breaths of 300 to 900/min (5-15 Hz) given over a set mean airway pressure. Both inhalation and exhalation are active.
|
| Active Comparator: High Frequency Oscillatory Ventilation (HFOV) without intrathoracic liver Babies who do not have any liver in the intrathoracic space will be placed on the HFOV at delivery or as soon as possible after consent. During analysis, these babies will be compared to babies without intrathoracic liver and randomized to HFJV. |
Device: High Frequency Oscillatory Ventilator
HFOV uses a piston diaphragm to generate alternating positive and negative pressure changes to give breaths of 300 to 900/min (5-15 Hz) given over a set mean airway pressure. Both inhalation and exhalation are active.
|
Outcome Measures
Primary Outcome Measures
- Oxygenation Index (OI) at 24 hours of age [24 hours of age]
The OI will be measured at 24 hours of age using a standard of care arterial blood gas and oxygen settings. These measurements will then be compared between the stratified groups
Secondary Outcome Measures
- PF ratio (PaO2/FiO2) measurements [up to one week]
These measurements will be determined at multiple time points for the first week of life. These measurements will be compared between groups.
- PF-PCO2 (PaO2/FiO2-PaCO2) measurements [up to one week]
These measurements will be determined at multiple time points for the first week of life. These measurements will be compared between groups.
- PaCO2 measurements [up to one week]
These measurements will be determined at multiple time points for the first week of life. These measurements will be compared between groups.
- Number of babies who received inhaled nitric oxide (iNO) [up to one week]
the number of babies who received treatment of iNO will be compared amongst the different groups
Other Outcome Measures
- Number of babies who survive to discharge [up to one year]
the number of babies who survive and are discharged will be compared amongst the groups
- Number of babies who required extracorporeal membrane oxygenation (ECMO) [up to one year]
the number of babies who required ECMO will be compared amongst the groups
- Number of days on mechanical ventilation [up to one year]
the number of days each baby required intubation and mechanical ventilation by any type will be compared amongst the groups
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Admitted to either the University of Utah and/or Primary Children's Hospital NICU within 24 hours of birth
-
Requiring mechanical ventilation
-
Umbilical arterial line or peripheral arterial line in place
-
Obtained signed consent
-
Infant is ≤ 24 hours of age
Exclusion Criteria:
-
Severe anomaly
-
Chromosomal abnormalities
-
Major congenital anomalies, including cardiac, central nervous system and syndromes
-
Post-natal diagnosis > 24 hours of life
-
Unable to obtain consent for participation
-
Unable to randomize within 24 hours of life
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Primary Children's Hospital | Salt Lake City | Utah | United States | 84113 |
| 2 | University Hospital | Salt Lake City | Utah | United States | 84132 |
Sponsors and Collaborators
- University of Utah
Investigators
- Principal Investigator: Michelle Yang, MD, University of Utah
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 133683