Clinical trial NCT01410149: Sleep Quality in Mechanically Ventilated Patients
Official title: The Influence of Mode and Patient-ventilator Interaction on Sleep Quality in the ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Keywords: PAV (proportional assist ventilation); sleep; polysomnography; mechanical ventilation
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Ontario Lung Association
name: Medtronic - MITG
First posted: 2011-08-04
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Patients requiring mechanical ventilation in the ICU will undergo three consecutive nights of polysomnography to record sleep patterns while receiving three modes of mechanical ventilation; Proportional assist ventilation (PAV), Pressure support ventilation (PSV), Assist control ventilation (ACV), applied in random order. The purpose is to determine the effect of mode of mechanical ventilation on patient-ventilator asynchrony and sleep quality.


Eligibility criteria: Inclusion Criteria:

* Age 18-75
* received mechanical ventilation \>72 hours
* glasgow coma scale \>10
* acute physiology score \<13
* ready for partial ventilatory support: intact respiratory drive, PaO2/FiO2 ratio \>200 on positive end expiratory pressure (PEEP) less than or equal to 5 cmH2O, and PH of 7.35 to 7.45
* sedation: analgesia at dose not higher than 0.01 mg/kg/hr morphine equivalent x 48 hours, sedation at dose not higher than 0.01 mg/kg/hr lorazepam equivalent x 72 hours.
* anticipate ongoing need for partial ventilatory support for the following 72 hours

Exclusion Criteria:

* Successful completion of spontaneous breathing trial
* Neurological injury, encephalopathy or abnormal EEG
* History of central sleep apnea
* General anaesthesia within 72 hours from study entry
* Requiring haloperidol \>10 mg/24 hours
* hemodynamically unstable
* sepsis

Primary outcomes:
measure: Sleep quality
timeFrame: 3 nights
Secondary outcomes:
measure: Patient-ventilator asynchrony
timeFrame: 3 nights
Other outcomes:
measure: Delirium
timeFrame: 3 days
measure: Comfort
timeFrame: 3 days
measure: Respiratory pattern
timeFrame: 3 nights
measure: Blood gas
timeFrame: evening and morning
Locations:
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Karen J. Bosma, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gabor JY, Cooper AB, Crombach SA, Lee B, Kadikar N, Bettger HE, Hanly PJ. Contribution of the intensive care unit environment to sleep disruption in mechanically ventilated patients and healthy subjects. Am J Respir Crit Care Med. 2003 Mar 1;167(5):708-15. doi: 10.1164/rccm.2201090.
citation: Parthasarathy S. Effects of sleep on patient-ventilator interaction. Respir Care Clin N Am. 2005 Jun;11(2):295-305. doi: 10.1016/j.rcc.2005.02.004.
citation: Cooper AB, Thornley KS, Young GB, Slutsky AS, Stewart TE, Hanly PJ. Sleep in critically ill patients requiring mechanical ventilation. Chest. 2000 Mar;117(3):809-18. doi: 10.1378/chest.117.3.809.
citation: Parthasarathy S. Sleep during mechanical ventilation. Curr Opin Pulm Med. 2004 Nov;10(6):489-94. doi: 10.1097/01.mcp.0000143691.94442.fa.
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citation: Parthasarathy S, Tobin MJ. Effect of ventilator mode on sleep quality in critically ill patients. Am J Respir Crit Care Med. 2002 Dec 1;166(11):1423-9. doi: 10.1164/rccm.200209-999OC. Epub 2002 Sep 5.
citation: Fanfulla F, Delmastro M, Berardinelli A, Lupo ND, Nava S. Effects of different ventilator settings on sleep and inspiratory effort in patients with neuromuscular disease. Am J Respir Crit Care Med. 2005 Sep 1;172(5):619-24. doi: 10.1164/rccm.200406-694OC. Epub 2005 Jun 16.
citation: Bosma K, Ferreyra G, Ambrogio C, Pasero D, Mirabella L, Braghiroli A, Appendini L, Mascia L, Ranieri VM. Patient-ventilator interaction and sleep in mechanically ventilated patients: pressure support versus proportional assist ventilation. Crit Care Med. 2007 Apr;35(4):1048-54. doi: 10.1097/01.CCM.0000260055.64235.7C.
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