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Effects Of Invasive And Noninvasive Mechanical Ventilation On Sleep In The Intensive Care Unit (ICU)

Effects Of Invasive And Noninvasive Mechanical Ventilation On Sleep In The Icu

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00638339
Enrollment
16
Registered
2008-03-19
Start date
2006-11-30
Completion date
2017-03-01
Last updated
2019-08-06

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

Conditions

Respiration, Artificial, Respiratory Insufficiency, Sleep Deprivation

Keywords

Respiration, artificial, respiratory insufficiency, noninvasive ventilation, sleep deprivation, intensive care units

Brief summary

The purpose of this study is to monitor sleep in patients using breathing machines, because little is known about sleep when patients use masks to help their breathing. We'd like to compare sleep in patients using masks to that in patients with a tube in their throats.

Detailed description

Sleep in critically-ill patients is commonly severely fragmented, and sleep architecture is altered as compared to a healthy person. This abnormal sleep may cause some important adverse psychological and physiological consequences. Noise, light, patient-care activities, pain, or medications are some of the contributing factors to sleep disruption in the ICU. Recent evidence also suggests that invasive mechanical ventilation (IMV) itself may lead to sleep fragmentation in the ICU. Noninvasive ventilation (NIV) is a well-established, relatively new form of ventilation which improves sleep quality or gas exchange in some patients with chronic hypoventilatory disorders. Although sleep may be disrupted due to discomfort from the mask or air leaking during NIV use; intermittent use of NIV may result in better sleep quality between NIV sessions. The effects of NIV on sleep in the acute care setting have not yet been studied. The purpose of the study is to describe the sleep architecture of a cohort of critically-ill patients using NIV, comparing findings to a reference group of patients using (IMV).

Interventions

None listed

Sponsors

Tufts Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \> 18 yrs * Receiving invasive or noninvasive mechanical ventilation * Anticipated further ventilation of at least 24-hour duration for IMV and 8 hours/ 24 hours for NIV

Exclusion criteria

* Pre-morbid diseases that could interfere with interpretation of sleep monitoring including CNS disorders (strokes, encephalopathic states), dementia, and known sleep disorders * On home BiPAP or CPAP * Depressed sensorium as evidence by Glasgow Coma Score \< 10, need for continuous sedation with Riker Score \< 2 and inability to follow verbal commands for sustained 3 hours * Presence of head trauma, psychiatric illness (including use of antidepressant medication), anoxic brain injury, drug overdose or uncontrolled seizure disorder * Severe hemodynamic instability (BP\< 90 mmHg despite vasopressor therapy) and sepsis * Recalcitrant hypoxemia (inability to sustain SaO2 \> 88%) * Considered as unstable by ICU team (hemodynamic instability, acute uncontrolled GI bleeding, acute cardiac ischemia or arrhythmias)

Design outcomes

Primary

MeasureTime frame
To define sleep characteristics in critically-ill patients receiving mechanical ventilation in medical ICU and coronary care unit (CCU)During 24-hour monitorization period (after recruitment into the study)

Secondary

MeasureTime frame
To determine sleep patterns during NIV use, correlating sleep with periods of use and air leakingDuring 24-hour monitorization
To compare total sleep time and differences in sleep architecture including time spent in different sleep stages and arousals in critically-ill patients receiving mechanical ventilation in medical ICU and CCUDuring 24-hour monitorization
To monitor environmental factors including noise, light and patient care activities, and to associate these with sleep patternsDuring 24-hour monitorization
To assess associations of severity of illness and sedation usage with sleep patternsDuring 24-hour monitorization period

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026