Clinical trial NCT05847374: Effect of Asynchronies on Sleep Disruption During Mechanical Ventilation
Official title: Relationship Between Asynchronies and Sleep Disruption in Mechanically Ventilated Patients: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep
Keywords: Mechanical Ventilation
Asynchronies
Sleep
Lead sponsor: Althaia Xarxa Assistencial Universitària de Manresa
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: After initial stabilization period, patients and relatives were invited to participate and to perform a sleep study.

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).

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.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Intubated and mechanically ventilated

Exclusion Criteria:

* Presence of recent major central nervous system disease impairing consciousness with Glasgow Coma Scale ≤ 8 with intubation
* Patients with a sleep breathing disorder when it is predominantly central sleep apnea; patients with predominantly obstructive sleep apnea can be included.
* Severe hemodynamic instability (high dose of vasopressors).
* Receiving muscle paralysis.

Primary outcomes:
measure: Correlation between sleep architecture using Odds Ratio Product (ORP) and asynchronies.
timeFrame: 24 hours
Secondary outcomes:
measure: Comparison of sleep disturbances between diurnal and nocturnal asynchronies
timeFrame: 24 hours
measure: Correlation between asynchronies and delirium
timeFrame: 28 days
measure: Correlation between sleep disruption and delirium
timeFrame: 28 dyas
Other outcomes:
Locations:
city: Manresa
country: Spain
facility: Althaia Xarxa Assistencial
state: Barcelona
Study officials:
affiliation: Althaia Xarxa Assitencial de Manresa
name: Rafael Fernandez Fernandez, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Younes M, Gerardy B, Pack AI, Kuna ST, Castro-Diehl C, Redline S. Sleep architecture based on sleep depth and propensity: patterns in different demographics and sleep disorders and association with health outcomes. Sleep. 2022 Jun 13;45(6):zsac059. doi: 10.1093/sleep/zsac059.