Effect of Asynchronies on Sleep Disruption During Mechanical Ventilation

NCT05847374 | Completed

• 1 other identifier: CE 18-74
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Sleep

Keywords

Mechanical Ventilation; Asynchronies; Sleep

Outcome Measures

Primary Outcomes (1)

• Correlation between sleep architecture using Odds Ratio Product (ORP) and asynchronies.

  ORP ranges and Sleep Architecture. Type and amount of asynchronies.

  24 hours

Secondary Outcomes (3)

• Comparison of sleep disturbances between diurnal and nocturnal asynchronies

  24 hours

• Correlation between asynchronies and delirium

  28 days

• Correlation between sleep disruption and delirium

  28 dyas

Interventions

Polysomnography DEVICE

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

After initial stabilization period, patients and relatives were invited to participate and to perform a sleep study.

You may qualify if:

• Age \> 18 years
• Intubated and mechanically ventilated

You may not qualify if:

• 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.

Sponsors & Collaborators

• Althaia Xarxa Assistencial Universitària de Manresa: lead

Study Sites (1)

Althaia Xarxa Assistencial

Manresa, Barcelona, 08243, Spain

Location

Related Publications (5)

• 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.

  PMID: 18502155 BACKGROUND

• 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.

  PMID: 29487094 BACKGROUND

• 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.

  PMID: 25693449 BACKGROUND

• 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.

  PMID: 22297667 BACKGROUND

• 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.

  PMID: 35272350 RESULT

MeSH Terms

Interventions

Polysomnography

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Rafael Fernandez Fernandez, PhD

  Althaia Xarxa Assitencial de Manresa

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 6, 2023
• Study Start: January 1, 2019
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)