Effect of Asynchronies on Sleep Disruption During Mechanical Ventilation

Sleep Clinical Trial

— SleepUCI  

Official title:

Relationship Between Asynchronies and Sleep Disruption in Mechanically Ventilated Patients: a Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05847374
• Other study ID #: CE 18-74
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: July 1, 2022

Study information

• Verified date: May 2023
• Source: Althaia Xarxa Assistencial Universitària de Manresa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sleep

Intervention

Device:
• Polysomnography
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.

Locations

Country	Name	City	State
Spain	Althaia Xarxa Assistencial	Manresa	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Althaia Xarxa Assistencial Universitària de Manresa

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View 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. — View 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. — View 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. Erratum In: Respir Care. 2019 Mar;64(3):e1. — View 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: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between sleep architecture using Odds Ratio Product (ORP) and asynchronies.	ORP ranges and Sleep Architecture. Type and amount of asynchronies.	24 hours
Secondary	Comparison of sleep disturbances between diurnal and nocturnal asynchronies	ORP ranges and Sleep Architecture. Type and amount of asynchronies.	24 hours
Secondary	Correlation between asynchronies and delirium	Type and amount of asynchronies and CAM-ICU delirium.	28 days
Secondary	Correlation between sleep disruption and delirium	ORP ranges and Sleep Architecture and CAM-ICU delirium.	28 dyas