Specific Aim 1) To identify the frequency and risk factors for PVA and its subtypes in ventilated children, with a specific focus on DC breaths. Hypothesis: PVA subtypes related to inadequate ventilator support (flow undershoot and premature cycling…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To identify the frequency and subtypes of PVA, as well as to train and validate
machine learning models.
Secondary outcome
Not applicable
Background summary
Patient ventilator asynchrony (PVA) is common but infrequently identified in
children. Pre-clinical studies show a clear causal relationship between certain
PVA subtypes and ventilator induced lung injury, diaphragm dysfunction, and
delirium. PVA may exacerbate ventilator induced lung injury (VILI),
particularly if PVA results in a double-cycled (DC) breath. DC breaths imply
that a second breath is delivered by the ventilator before the patient has
fully exhaled. Double cycled breaths (DC) are particularly injurious because
the resultant breath stacking causes unintentionally large tidal volumes and
trans-pulmonary pressures, which exacerbates regional overdistension of the
lung, and is associated with mortality in adults with ARDS.
Study objective
Specific Aim 1) To identify the frequency and risk factors for PVA and its
subtypes in ventilated children, with a specific focus on DC breaths.
Hypothesis: PVA subtypes related to inadequate ventilator support (flow
undershoot and premature cycling) and reverse triggering will be the most
common causes of DC breaths, with risk factors related to respiratory drive and
ventilator settings.
Specific Aim 2) To develop and test a clinical decision support system using
machine learning techniques to automatically identify common forms of PVA in
children. Hypothesis: (a) Machine learning models using waveforms available on
all mechanical ventilators will accurately identify PVA subtypes compared to
gold standard annotations which include measures of neural drive. (b)
Algorithms can be optimized for high sensitivity and low false alert rates to
identify children with frequent PVA.
Study design
Multi-center prospective observational cohort.
Study burden and risks
Minimal. For this study, no deviation from standard care will occur. Data will
be collected from the mechanical ventilator. sEMG electrodes will be used to
quantify the electrical activity of respiratory muscles.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
age > 37 weeks CGA to 18 years
anticipated to be mechanically ventilated for at least 24 hours within 96 hours
of initiation of invasive mechanical ventilation
Exclusion criteria
Serious skin defects that prevent sEMG stickers from being placed
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL85342.042.23 |