Sleep Quality in Mechanically Ventilated Patients - Full Text View

Purpose

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.

Condition	Intervention
Respiratory Failure	Other: PAV Other: PSV Other: ACV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	The Influence of Mode and Patient-ventilator Interaction on Sleep Quality in the ICU

Resource links provided by NLM:

MedlinePlus related topics: Respiratory Failure

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:

Sleep quality [ Time Frame: 3 nights ] [ Designated as safety issue: No ]
Sleep fragmentation (number of arousals and awakenings/hr sleep), sleep architecture (% time asleep spent in Stage 1, 2, 3/4 and REM sleep)

Secondary Outcome Measures:

Patient-ventilator asynchrony [ Time Frame: 3 nights ] [ Designated as safety issue: No ]
Incidence of patient-ventilator asynchrony (asynchrony index, % of asynchronous breaths per minute)

Other Outcome Measures:

Delirium [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Positive score on a delirium screening tool (CAM-ICU or ICDSC)
Comfort [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Patient's assessment of their own breathing comfort and their perceived quality of sleep, indicated on a visual analogue scale
Respiratory pattern [ Time Frame: 3 nights ] [ Designated as safety issue: No ]
Measurement of average tidal volume, respiratory rate, minute ventilation and non-invasive measurement of respiratory muscle effort relative to maximum effort
Blood gas [ Time Frame: evening and morning ] [ Designated as safety issue: No ]
measurement of paO2 and paCO2

Enrollment:	13
Study Start Date:	April 2007
Study Completion Date:	December 2011
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: PAV Proportional Assist Ventilation (PAV+ on PB840 ventilator)	Other: PAV Proportional Assist Ventilation will be used to ventilate the patient for a 24 hour period
Active Comparator: PSV Pressure Support Ventilation (PSV on PB840 ventilator)	Other: PSV Pressure Support Ventilation will be used to ventilate the patient for a 24 hour period
Active Comparator: ACV Assist Control/ Pressure limited Ventilation (on PB840 ventilator)	Other: ACV Assist Control Ventilation will be used to ventilate the patient for a 24 hour period

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01410149

Locations

Canada, Ontario
London Health Sciences Centre - University Hospital
London, Ontario, Canada, N6A 5A5

Sponsors and Collaborators

Lawson Health Research Institute

Ontario Lung Association

Covidien

Investigators

Principal Investigator:

Karen J. Bosma, MD, FRCPC

Lawson Health Research Institute

More Information

Publications:

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.

Parthasarathy S. Effects of sleep on patient-ventilator interaction. Respir Care Clin N Am. 2005 Jun;11(2):295-305. Review.

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. Erratum in: Chest 2001 Mar;119(3):993.

Parthasarathy S. Sleep during mechanical ventilation. Curr Opin Pulm Med. 2004 Nov;10(6):489-94. Review.

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.

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.

Chen HI, Tang YR. Sleep loss impairs inspiratory muscle endurance. Am Rev Respir Dis. 1989 Oct;140(4):907-9.

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. 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. 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.

Meza S, Mendez M, Ostrowski M, Younes M. Susceptibility to periodic breathing with assisted ventilation during sleep in normal subjects. J Appl Physiol. 1998 Nov;85(5):1929-40.

Younes M. Proportional assist ventilation, a new approach to ventilatory support. Theory. Am Rev Respir Dis. 1992 Jan;145(1):114-20.

Responsible Party:	Karen Bosma, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT01410149 History of Changes
Other Study ID Numbers:	R-07-106, 13114
Study First Received:	August 3, 2011
Last Updated:	August 13, 2012
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:

PAV (proportional assist ventilation); sleep; polysomnography; mechanical ventilation

Additional relevant MeSH terms:

Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013