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Completed

NCT Number: NCT05847374

Effect of Asynchronies on Sleep Disruption During Mechanical Ventilation

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).

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Key information

Conditions

Sleep

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Althaia Xarxa Assistencial

Manresa, Barcelona, 08243, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Ventilator waveforms recording

Primary outcomes

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

    Time frame: 24 hours

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

Secondary outcomes

  1. Comparison of sleep disturbances between diurnal and nocturnal asynchronies

    Time frame: 24 hours

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

  2. Correlation between asynchronies and delirium

    Time frame: 28 days

    Type and amount of asynchronies and CAM-ICU delirium.

  3. Correlation between sleep disruption and delirium

    Time frame: 28 dyas

    ORP ranges and Sleep Architecture and CAM-ICU delirium.

Sponsors and collaborators

Lead sponsor

Althaia Xarxa Assistencial Universitària de Manresa

Other

Registry information

Official study title

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

Acronym: SleepUCI

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 6, 2023
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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