Effect of Asynchronies on Sleep Disruption During Mechanical Ventilation

Completed

• Conditions: Sleep

• Registration Number: NCT05847374
• Lead Sponsor: Althaia Xarxa Assistencial Universitària de Manresa

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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01
• Study First Submitted: 2023-04-27
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-05
• Study First Posted: 2023-05-06
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between sleep architecture using Odds Ratio Product (ORP) and asynchronies.	24 hours	ORP ranges and Sleep Architecture. Type and amount of asynchronies.

Secondary Outcome Measures

Name	Time	Method
Comparison of sleep disturbances between diurnal and nocturnal asynchronies	24 hours	ORP ranges and Sleep Architecture. Type and amount of asynchronies.
Correlation between asynchronies and delirium	28 days	Type and amount of asynchronies and CAM-ICU delirium.
Correlation between sleep disruption and delirium	28 dyas	ORP ranges and Sleep Architecture and CAM-ICU delirium.

Trial Locations

Locations (1)

Althaia Xarxa Assistencial; 🇪🇸 Manresa, Barcelona, Spain