Clinical trial NCT00638339: Effects Of Invasive And Noninvasive Mechanical Ventilation On Sleep In The Intensive Care Unit (ICU)
Official title: Effects Of Invasive And Noninvasive Mechanical Ventilation On Sleep In The Icu
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Insufficiency
Respiration, Artificial
Sleep Deprivation
Keywords: Respiration, artificial
respiratory insufficiency
noninvasive ventilation
sleep deprivation
intensive care units
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2008-03-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients undergoing invasive or noninvasive mechanical ventilation in medical ICU and CCU at Tufts New England Medical Center

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).

Eligibility criteria: 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)

Primary outcomes:
measure: To define sleep characteristics in critically-ill patients receiving mechanical ventilation in medical ICU and coronary care unit (CCU)
timeFrame: During 24-hour monitorization period (after recruitment into the study)
Secondary outcomes:
measure: 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 CCU
timeFrame: During 24-hour monitorization
measure: To determine sleep patterns during NIV use, correlating sleep with periods of use and air leaking
timeFrame: During 24-hour monitorization
measure: To monitor environmental factors including noise, light and patient care activities, and to associate these with sleep patterns
timeFrame: During 24-hour monitorization
measure: To assess associations of severity of illness and sedation usage with sleep patterns
timeFrame: During 24-hour monitorization period
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts-New England Medical Center Medical ICU and Coronary Care Unit
state: Massachusetts
Study officials:
affiliation: Research Fellow
name: Aylin Ozsancak, MD
role: STUDY_DIRECTOR
affiliation: Chair of Pulmonary, Critical Care and Sleep Medicine Division
name: Nicholas S Hill, MD
role: PRINCIPAL_INVESTIGATOR
References: