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

Sponsored by:	Tufts Medical Center
Information provided by:	Tufts Medical Center
ClinicalTrials.gov Identifier:	NCT00638339

Purpose

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.

Condition
Respiratory Insufficiency Respiration, Artificial Sleep Deprivation

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Effects Of Invasive And Noninvasive Mechanical Ventilation On Sleep In The Icu

Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:

To define sleep characteristics in critically-ill patients receiving mechanical ventilation in medical ICU and coronary care unit (CCU) [ Time Frame: During 24-hour monitorization period (after recruitment into the study) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: During 24-hour monitorization ] [ Designated as safety issue: No ]
To determine sleep patterns during NIV use, correlating sleep with periods of use and air leaking [ Time Frame: During 24-hour monitorization ] [ Designated as safety issue: No ]
To monitor environmental factors including noise, light and patient care activities, and to associate these with sleep patterns [ Time Frame: During 24-hour monitorization ] [ Designated as safety issue: No ]
To assess associations of severity of illness and sedation usage with sleep patterns [ Time Frame: During 24-hour monitorization period ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	20
Study Start Date:	November 2006
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 critically ill patients undergoing invasive mechanical ventilation in medical ICU and CCU
2 critically ill patients undergoing noninvasive mechanical ventilation in medical ICU and CCU

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638339

Contacts

Contact: Aylin Ozsancak, MD	617-636-3229	aozsancak@tufts-nemc.org
Contact: Nicholas S Hill, MD	617-636-4288	nhill@tufts-nemc.org

Locations

United States, Massachusetts
Tufts-New England Medical Center Medical ICU and Coronary Care Unit	Recruiting
Boston, Massachusetts, United States, 02111
Sub-Investigator: Carolyn D'Ambrosio, MD
Principal Investigator: Nicholas S. Hill, M.D
Sub-Investigator: Erik Garpestad, MD
Sub-Investigator: Aylin Ozsancak, M.D
Sub-Investigator: John Brennan, MD

Sponsors and Collaborators

Tufts Medical Center

Investigators

Study Director:	Aylin Ozsancak, MD	Research Fellow
Principal Investigator:	Nicholas S Hill, MD	Chair of Pulmonary, Critical Care and Sleep Medicine Division

More Information

Responsible Party:	Tufts Medical Center ( Nicholas S. Hill, M.D. )
Study ID Numbers:	IRB-8053
Study First Received:	March 12, 2008
Last Updated:	March 18, 2008
ClinicalTrials.gov Identifier:	NCT00638339
Health Authority:	United States: Institutional Review Board

Keywords provided by Tufts Medical Center:

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

Study placed in the following topic categories:

Signs and Symptoms
Respiratory Insufficiency
Respiratory Tract Diseases
Mental Disorders
Respiration Disorders

Neurologic Manifestations
Sleep Disorders
Dyssomnias
Sleep Deprivation

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009