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
Aperçu de l'étude
Statut
Description détaillée
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).
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Massachusetts
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Boston, Massachusetts, États-Unis, 02111
- Tufts-New England Medical Center Medical ICU and Coronary Care Unit
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cas-témoins
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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To define sleep characteristics in critically-ill patients receiving mechanical ventilation in medical ICU and coronary care unit (CCU)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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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
Délai: 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
Délai: During 24-hour monitorization
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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
Délai: During 24-hour monitorization
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During 24-hour monitorization
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To assess associations of severity of illness and sedation usage with sleep patterns
Délai: During 24-hour monitorization period
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During 24-hour monitorization period
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Aylin Ozsancak, MD, research fellow
- Chercheur principal: Nicholas S Hill, MD, Chair of Pulmonary, Critical Care and Sleep Medicine Division
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB-8053
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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produit fabriqué et exporté des États-Unis.
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