SleepUCI: Effect of Asynchronies on Sleep Disruption During Mechanical Ventilation
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Correlation between sleep architecture using Odds Ratio Product (ORP) and asynchronies. [24 hours]
ORP ranges and Sleep Architecture. Type and amount of asynchronies.
Secondary Outcome Measures
- Comparison of sleep disturbances between diurnal and nocturnal asynchronies [24 hours]
ORP ranges and Sleep Architecture. Type and amount of asynchronies.
- Correlation between asynchronies and delirium [28 days]
Type and amount of asynchronies and CAM-ICU delirium.
- Correlation between sleep disruption and delirium [28 dyas]
ORP ranges and Sleep Architecture and CAM-ICU delirium.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age > 18 years
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Intubated and mechanically ventilated
Exclusion Criteria:
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Presence of recent major central nervous system disease impairing consciousness with Glasgow Coma Scale ≤ 8 with intubation
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Patients with a sleep breathing disorder when it is predominantly central sleep apnea; patients with predominantly obstructive sleep apnea can be included.
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Severe hemodynamic instability (high dose of vasopressors).
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Receiving muscle paralysis.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Althaia Xarxa Assistencial | Manresa | Barcelona | Spain | 08243 |
Sponsors and Collaborators
- Althaia Xarxa Assistencial Universitària de Manresa
Investigators
- Study Director: Rafael Fernandez Fernandez, PhD, Althaia Xarxa Assitencial de Manresa
Study Documents (Full-Text)
More Information
Publications
- Blanch L, Sales B, Montanya J, Lucangelo U, Garcia-Esquirol O, Villagra A, Chacon E, Estruga A, Borelli M, Burgueno MJ, Oliva JC, Fernandez R, Villar J, Kacmarek R, Murias G. Validation of the Better Care(R) system to detect ineffective efforts during expiration in mechanically ventilated patients: a pilot study. Intensive Care Med. 2012 May;38(5):772-80. doi: 10.1007/s00134-012-2493-4. Erratum In: Intensive Care Med. 2013 Feb;39(2):341.
- Blanch L, Villagra A, Sales B, Montanya J, Lucangelo U, Lujan M, Garcia-Esquirol O, Chacon E, Estruga A, Oliva JC, Hernandez-Abadia A, Albaiceta GM, Fernandez-Mondejar E, Fernandez R, Lopez-Aguilar J, Villar J, Murias G, Kacmarek RM. Asynchronies during mechanical ventilation are associated with mortality. Intensive Care Med. 2015 Apr;41(4):633-41. doi: 10.1007/s00134-015-3692-6. Epub 2015 Feb 19.
- Drouot X, Cabello B, d'Ortho MP, Brochard L. Sleep in the intensive care unit. Sleep Med Rev. 2008 Oct;12(5):391-403. doi: 10.1016/j.smrv.2007.11.004. Epub 2008 May 23.
- Subira C, de Haro C, Magrans R, Fernandez R, Blanch L. Minimizing Asynchronies in Mechanical Ventilation: Current and Future Trends. Respir Care. 2018 Apr;63(4):464-478. doi: 10.4187/respcare.05949. Epub 2018 Feb 27. Erratum In: Respir Care. 2019 Mar;64(3):e1.
- CE 18-74