- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00638339
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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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).
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Massachusetts
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Boston, Massachusetts, Förenta staterna, 02111
- Tufts-New England Medical Center Medical ICU and Coronary Care Unit
-
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Case-Control
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
|---|
|
1
critically ill patients undergoing invasive mechanical ventilation in medical ICU and CCU
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|
2
critically ill patients undergoing noninvasive mechanical ventilation in medical ICU and CCU
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
To define sleep characteristics in critically-ill patients receiving mechanical ventilation in medical ICU and coronary care unit (CCU)
Tidsram: During 24-hour monitorization period (after recruitment into the study)
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During 24-hour monitorization period (after recruitment into the study)
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
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
Tidsram: During 24-hour monitorization
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During 24-hour monitorization
|
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To determine sleep patterns during NIV use, correlating sleep with periods of use and air leaking
Tidsram: During 24-hour monitorization
|
During 24-hour monitorization
|
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To monitor environmental factors including noise, light and patient care activities, and to associate these with sleep patterns
Tidsram: During 24-hour monitorization
|
During 24-hour monitorization
|
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To assess associations of severity of illness and sedation usage with sleep patterns
Tidsram: During 24-hour monitorization period
|
During 24-hour monitorization period
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Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Aylin Ozsancak, MD, research fellow
- Huvudutredare: Nicholas S Hill, MD, Chair of Pulmonary, Critical Care and Sleep Medicine Division
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB-8053
Plan för individuella deltagardata (IPD)
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