Fragmented sleep in critically ill patients using a ventilator and its relationship with coming off the ventilator

Sleep fragmentation induced by patient–ventilator asynchrony as a factor associated with weaning failure in critically ill patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

REBEC

Registry ID

RBR-6tq4k4q

Enrollment

Registered

2026-06-16

Start date

2026-06-01

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiration Artificial, Ventilator Weaning sono

Interventions

This is a prospective cross sectional observational study involving 48 adult patients under invasive mechanical ventilation admitted to an intensive care unit and eligible for ventilator weaning. Part

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients aged 18 years or older under invasive mechanical ventilation for more than 48 hours; eligible for ventilator weaning; preserved level of consciousness with Glasgow Coma Scale score equal to or greater than 9; mild to moderate sedation with Richmond Agitation Sedation Scale between minus 2 and 0

Exclusion criteria

Exclusion criteria: Patients with hemodynamic instability; recent use of neuromuscular blocking agents; fraction of inspired oxygen equal to or greater than 0 point 6; positive end expiratory pressure equal to or greater than 10 centimeters of water; contraindication to ventilator weaning; tracheostomy; pregnancy

Design outcomes

Primary

Measure	Time frame
It is expected to identify an association between sleep fragmentation and success or failure of ventilator weaning in critically ill patients under invasive mechanical ventilation. The outcome will be assessed according to extubation results, considering success as the absence of reintubation within the first 48 hours after extubation and failure as the need for reintubation during this period. Data will be collected during the pre extubation period and followed up for 48 hours after extubation	—

Measure

Time frame

It is expected to identify an association between sleep fragmentation and success or failure of ventilator weaning in critically ill patients under invasive mechanical ventilation. The outcome will be assessed according to extubation results, considering success as the absence of reintubation within the first 48 hours after extubation and failure as the need for reintubation during this period. Data will be collected during the pre extubation period and followed up for 48 hours after extubation

—

Secondary

Measure	Time frame
It is expected to observe associations between sleep fragmentation, hypoxic burden, subjective sleep quality, patient ventilator asynchronies and ventilatory parameters with ventilator weaning outcome. Variables will be assessed using portable multimodal polysomnography, actigraphy, Richards Campbell Sleep Questionnaire and ventilatory monitoring during the pre extubation period and within the first 48 hours after extubation	—

Measure

Time frame

It is expected to observe associations between sleep fragmentation, hypoxic burden, subjective sleep quality, patient ventilator asynchronies and ventilatory parameters with ventilator weaning outcome. Variables will be assessed using portable multimodal polysomnography, actigraphy, Richards Campbell Sleep Questionnaire and ventilatory monitoring during the pre extubation period and within the first 48 hours after extubation

—

Countries

Contacts

Public ContactMarcelo Corrêa

Hospital Municipal Ronaldo Gazolla

marcelosousacorrea69@gmail.com+5521967956705

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Jun 29, 2026