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

This study is currently recruiting participants.
Verified May 2012 by Tufts Medical Center
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00638339
First received: March 12, 2008
Last updated: May 30, 2012
Last verified: May 2012

March 12, 2008
May 30, 2012
November 2006
December 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00638339 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

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).

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Critically ill patients undergoing invasive or noninvasive mechanical ventilation in medical ICU and CCU at Tufts New England Medical Center

  • Respiratory Insufficiency
  • Respiration, Artificial
  • Sleep Deprivation
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2012
December 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Nicholas S Hill, MD 617-636-4288 nhill@tufts-nemc.org
Contact: Aylin Ozsancak, MD 01190-532-742-5233 aozsancak@hotmail.com
United States
 
NCT00638339
IRB-8053
No
Tufts Medical Center
Tufts Medical Center
Not Provided
Study Director: Aylin Ozsancak, MD Research Fellow
Principal Investigator: Nicholas S Hill, MD Chair of Pulmonary, Critical Care and Sleep Medicine Division
Tufts Medical Center
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP