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.

Study Overview

• Status: Completed
• Conditions: Respiratory Insufficiency; Sleep Deprivation; Respiration, Artificial

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
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts-New England Medical Center Medical ICU and Coronary Care Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To define sleep characteristics in critically-ill patients receiving mechanical ventilation in medical ICU and coronary care unit (CCU)	During 24-hour monitorization period (after recruitment into the study)

Secondary Outcome Measures

Outcome Measure	Time Frame
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	During 24-hour monitorization
To determine sleep patterns during NIV use, correlating sleep with periods of use and air leaking	During 24-hour monitorization
To monitor environmental factors including noise, light and patient care activities, and to associate these with sleep patterns	During 24-hour monitorization
To assess associations of severity of illness and sedation usage with sleep patterns	During 24-hour monitorization period

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2006
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: March 12, 2008
• First Submitted That Met QC Criteria: March 18, 2008
• First Posted (Estimate): March 19, 2008

Study Record Updates

• Last Update Posted (Actual): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: noninvasive ventilation; intensive care units; Respiration, artificial; respiratory insufficiency; sleep deprivation
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Respiratory Insufficiency; Sleep Deprivation
• Other Study ID Numbers: IRB-8053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No