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SleepSleepUCINCT05847374

Effect of Asynchronies on Sleep Disruption During Mechanical Ventilation

An observational study of Sleep, run by Althaia Xarxa Assistencial Universitària de Manresa at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Sleep
What is being tested?
Polysomnography
Type of treatment
Medical device
How many people
50 participants
Where
1 siteSpain
Study dates
1 Jan 2019to 1 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Age > 18 years
  • Intubated and mechanically ventilated

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Althaia Xarxa Assistencial

    Manresa, Barcelona, 08243

Other trials in Spain

About this study

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

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.

Read more

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).

Read the 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.

Conditions
Sleep
Being tested
Polysomnography
Keywords
Mechanical Ventilation, Asynchronies, Sleep

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PolysomnographyDevice

    Also called Ventilator waveforms recording

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 24 hours

Secondary outcomes (3)

  1. Comparison of sleep disturbances between diurnal and nocturnal asynchronies

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

    Measured: 24 hours

  2. Correlation between asynchronies and delirium

    Type and amount of asynchronies and CAM-ICU delirium.

    Measured: 28 days

  3. Correlation between sleep disruption and delirium

    ORP ranges and Sleep Architecture and CAM-ICU delirium.

    Measured: 28 dyas

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study start1 Jan 2019
  3. Primary completion1 Jul 2022
  4. Study completion1 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05847374
Sponsor's protocol ID
CE 18-74
Acronym
SleepUCI
Status last verified
May 2023
First submitted
27 Apr 2023
Last updated
10 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: After formal consultation, the investigators might share specific data with other researchers for specific proposals.

Publications

  • 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.

    PubMed 18502155

  • 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.

    PubMed 29487094

  • 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.

    PubMed 25693449

  • 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.

    PubMed 22297667

  • 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.

    PubMed 35272350

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep, run by Althaia Xarxa Assistencial Universitària de Manresa at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between sleep architecture using Odds Ratio Product (ORP) and asynchronies. (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05847374, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.

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