View Clinical Trial (Medical Research Study)
Effects Of Invasive And Noninvasive Mechanical Ventilation On Sleep In The Icu
| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02111 |
| Conditions: |
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Respiratory Insufficiency - Respiration, Artificial - Sleep Deprivation |
| Purpose: |
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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.
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| Study Summary: |
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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).
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| Criteria: |
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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)
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| NCT ID: |
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NCT00638339 |
| Primary Contact: |
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Study Director
Aylin Ozsancak, MD
Research Fellow
Nicholas S Hill, MD
Phone: 617-636-4288
Email: nhill@tufts-nemc.org
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| Backup Contact: |
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Email: aozsancak@hotmail.com
Aylin Ozsancak, MD
Phone: 01190-532-742-5233
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| Location Contact: |
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Boston, Massachusetts 02111
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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