Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
13 participants
INTERVENTIONAL
2007-04-30
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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PAV
Proportional Assist Ventilation (PAV+ on PB840 ventilator)
PAV
Proportional Assist Ventilation will be used to ventilate the patient for a 24 hour period
PSV
Pressure Support Ventilation (PSV on PB840 ventilator)
PSV
Pressure Support Ventilation will be used to ventilate the patient for a 24 hour period
ACV
Assist Control/ Pressure limited Ventilation (on PB840 ventilator)
ACV
Assist Control Ventilation will be used to ventilate the patient for a 24 hour period
Interventions
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PAV
Proportional Assist Ventilation will be used to ventilate the patient for a 24 hour period
PSV
Pressure Support Ventilation will be used to ventilate the patient for a 24 hour period
ACV
Assist Control Ventilation will be used to ventilate the patient for a 24 hour period
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Ontario Lung Association
OTHER
Medtronic - MITG
INDUSTRY
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Karen Bosma
Principal Investigator
Principal Investigators
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Karen J. Bosma, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Locations
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London Health Sciences Centre - University Hospital
London, Ontario, Canada
Countries
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References
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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.
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.
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.
Parthasarathy S. Sleep during mechanical ventilation. Curr Opin Pulm Med. 2004 Nov;10(6):489-94. doi: 10.1097/01.mcp.0000143691.94442.fa.
Freedman NS, Gazendam J, Levan L, Pack AI, Schwab RJ. Abnormal sleep/wake cycles and the effect of environmental noise on sleep disruption in the intensive care unit. Am J Respir Crit Care Med. 2001 Feb;163(2):451-7. doi: 10.1164/ajrccm.163.2.9912128.
Irwin M, McClintick J, Costlow C, Fortner M, White J, Gillin JC. Partial night sleep deprivation reduces natural killer and cellular immune responses in humans. FASEB J. 1996 Apr;10(5):643-53. doi: 10.1096/fasebj.10.5.8621064.
Chen HI, Tang YR. Sleep loss impairs inspiratory muscle endurance. Am Rev Respir Dis. 1989 Oct;140(4):907-9. doi: 10.1164/ajrccm/140.4.907.
Helton MC, Gordon SH, Nunnery SL. The correlation between sleep deprivation and the intensive care unit syndrome. Heart Lung. 1980 May-Jun;9(3):464-8. No abstract available.
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.
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.
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.
Meza S, Mendez M, Ostrowski M, Younes M. Susceptibility to periodic breathing with assisted ventilation during sleep in normal subjects. J Appl Physiol (1985). 1998 Nov;85(5):1929-40. doi: 10.1152/jappl.1998.85.5.1929.
Younes M. Proportional assist ventilation, a new approach to ventilatory support. Theory. Am Rev Respir Dis. 1992 Jan;145(1):114-20. doi: 10.1164/ajrccm/145.1.114.
Other Identifiers
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13114
Identifier Type: OTHER
Identifier Source: secondary_id
R-07-106
Identifier Type: -
Identifier Source: org_study_id