An observational study in Sleep, sponsored by Althaia Xarxa Assistencial Universitària de Manresa. Completed at 1 site in Spain. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-05-10.
Sponsored by Althaia Xarxa Assistencial Universitària de Manresa · Observational
Mechanically ventilated (MV) patients in the Intensive Care Unit (ICU) are highly susceptible to sleep disruption. Several studies in the last 15 years have demonstrated an extremely poor sleep quality and abnormal sleep pattern evaluated by polysomnography (PSG) devices (the gold standard method for evaluating sleep quality and quantity).
Patient-ventilator interaction is frequently poor leading to asynchronies of varied type and consequences. Moderate-to-severe asynchronies are associated with longer mechanical ventilation, weaning failure and mortality.
The goal of this study is to look for an association between poor sleep quality and patient-ventilator asynchronies.
This study is an observational, physiological study investigating sleep quality and quantity in MV patients by recording portable PSG (from 22:00 to 08:00) at night while continuously monitoring 24h/day of patient-ventilator interaction (BetterCare system).
This clinical physiological study took place after MV patients have survived the initial critical admission phase (severe hypoxemia or shock) and before approaching weaning.
After enrolment, a single night, sleep architecture was recorded using standard PSG (electroencephalography, right and left electrooculography, submental electromyography and electrocardiography) from 24:00 to 8:00. Pulse oximetry (SpO2) and heart rate will be recorded continuously during the PSG.
Assessment of delirium was performed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) every 8 hours (at 08:00, 16:00 and 24:00) from day 0 until discharge.
Althaia Xarxa Assistencial Universitària de Manresa is the lead sponsor of 21 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
After initial stabilization period, patients and relatives were invited to participate and to perform a sleep study.
Exclusion Criteria:
Sleep architecture will be recorded using portable PSG (Prodigy) from 24:00 to 8:00. Pulse oximetry (SpO2) and heart rate were recorded continuously during the PSG. Simultaneously, the waveforms from the ventilator were recorded using Bettercare (R) system.
Also known as: Ventilator waveforms recording
Correlation between sleep architecture using Odds Ratio Product (ORP) and asynchronies.
ORP ranges and Sleep Architecture. Type and amount of asynchronies.
Time frame: 24 hours
Comparison of sleep disturbances between diurnal and nocturnal asynchronies
ORP ranges and Sleep Architecture. Type and amount of asynchronies.
Time frame: 24 hours
Correlation between asynchronies and delirium
Type and amount of asynchronies and CAM-ICU delirium.
Time frame: 28 days
Correlation between sleep disruption and delirium
ORP ranges and Sleep Architecture and CAM-ICU delirium.
Time frame: 28 dyas
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — After formal consultation, the investigators might share specific data with other researchers for specific proposals.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Althaia Xarxa Assistencial Universitària de Manresa