The aim of this study is to compare sleep depth parameters measured from PSG and the (a)EEG signal from the CFM. A secondary objective is to combine different measures that are routinely measured in the PICU to create a simple system that can…
ID
Source
Brief title
Condition
- Sleep disturbances (incl subtypes)
- Sleep disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The ICC between sleep depth parameters measured from PSG, the gold standard,
and the EEG signal from the CFM.
Secondary outcome
- The ICC, F-score and Cohen*s kappa between sleep states measured from PSG,
the gold standard, and our newly designed classification system for different
sleep classifications:
- The ICC between different sleep characteristics between the PSG and the
created classification system
Background summary
Critically ill children admitted to the pediatric intensive care unit (PICU)
are exposed to multiple factors which increase the propensity for sleep
disruption which may, in turn, play a role recovery from critical illness.
Polysomnography (PSG) is considered gold standard in sleep analysis. However,
PSG based sleep analysis in the PICU is challenging since it is elaborate,
expensive, and labor-intensive. Other methods to quantify sleep are less
reliable for the use in the PICU, because of the effect of the sedation or
immobility while mechanically ventilated. This signifies the need for a simpler
and more manageable system for monitoring sleep in the PICU.
Study objective
The aim of this study is to compare sleep depth parameters measured from PSG
and the (a)EEG signal from the CFM. A secondary objective is to combine
different measures that are routinely measured in the PICU to create a simple
system that can monitor sleep in the PICU.
Study design
Prospective, observational study. The study will start May 1st, 2025 and is
completed by February 28th, 2026
Study burden and risks
The subjects of the study will not benefit from the study, but the risks will
be minimal due to potential discomfort from electrodes etc. The outcome of this
study can greatly improve the knowledge on the importance of sleep in the
pediatric critical care.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
- Patients admitted to the PICU and expected to be mechanically ventilated for
more than 24 hours below 2 years of age.
- Connected to the CFM monitor
Exclusion criteria
- Premature birth with gestational age corrected for post-conceptional age less
than 40 weeks.
- Congenital or acquired neuromuscular disorders.
- Congenital or acquired central nervous system disorders.
- Severe traumatic brain injury (i.e. Glasgow Coma Scale < 8).
- Congenital or acquired damage to the phrenic nerve.
- Congenital or acquired paralysis of the diaphragm.
- Use of neuromuscular blockade.
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 | NL82716.042.23 |