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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00638339
Recruitment Status : Active, not recruiting
First Posted : March 19, 2008
Last Update Posted : May 28, 2018
Information provided by (Responsible Party):
Tufts 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.

Condition or disease
Respiratory Insufficiency Respiration, Artificial Sleep Deprivation

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).

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effects Of Invasive And Noninvasive Mechanical Ventilation On Sleep In The Icu
Actual Study Start Date : November 2006
Actual Primary Completion Date : December 2013
Estimated Study Completion Date : December 2018

critically ill patients undergoing invasive mechanical ventilation in medical ICU and CCU
critically ill patients undergoing noninvasive mechanical ventilation in medical ICU and CCU

Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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 ]
  2. To determine sleep patterns during NIV use, correlating sleep with periods of use and air leaking [ Time Frame: During 24-hour monitorization ]
  3. To monitor environmental factors including noise, light and patient care activities, and to associate these with sleep patterns [ Time Frame: During 24-hour monitorization ]
  4. To assess associations of severity of illness and sedation usage with sleep patterns [ Time Frame: During 24-hour monitorization period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00638339

United States, Massachusetts
Tufts-New England Medical Center Medical ICU and Coronary Care Unit
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
Study Director: Aylin Ozsancak, MD Research Fellow
Principal Investigator: Nicholas S Hill, MD Chair of Pulmonary, Critical Care and Sleep Medicine Division

Responsible Party: Tufts Medical Center Identifier: NCT00638339     History of Changes
Other Study ID Numbers: IRB-8053
First Posted: March 19, 2008    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tufts Medical Center:
Respiration, artificial
respiratory insufficiency
noninvasive ventilation
sleep deprivation
intensive care units

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Sleep Deprivation
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders