NCT01410149

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 15, 2012

Status Verified

August 1, 2012

Enrollment Period

3.7 years

First QC Date

August 3, 2011

Last Update Submit

August 13, 2012

Conditions

Respiratory Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Sleep quality

    Sleep fragmentation (number of arousals and awakenings/hr sleep), sleep architecture (% time asleep spent in Stage 1, 2, 3/4 and REM sleep)

    3 nights

Secondary Outcomes (1)

  • Patient-ventilator asynchrony

    3 nights

Other Outcomes (4)

  • Delirium

    3 days

  • Comfort

    3 days

  • Respiratory pattern

    3 nights

  • +1 more other outcomes

Study Arms (3)

PAV

ACTIVE COMPARATOR

Proportional Assist Ventilation (PAV+ on PB840 ventilator)

Other: PAV

PSV

ACTIVE COMPARATOR

Pressure Support Ventilation (PSV on PB840 ventilator)

Other: PSV

ACV

ACTIVE COMPARATOR

Assist Control/ Pressure limited Ventilation (on PB840 ventilator)

Other: ACV

Interventions

PAVOTHER

Proportional Assist Ventilation will be used to ventilate the patient for a 24 hour period

PAV
PSVOTHER

Pressure Support Ventilation will be used to ventilate the patient for a 24 hour period

PSV
ACVOTHER

Assist Control Ventilation will be used to ventilate the patient for a 24 hour period

ACV

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre - University Hospital

London, Ontario, N6A 5A5, Canada

Location

Related Publications (13)

  • 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.

    PMID: 12598213BACKGROUND

  • 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.

    PMID: 15936695BACKGROUND

  • 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.

    PMID: 10713011BACKGROUND

  • Parthasarathy S. Sleep during mechanical ventilation. Curr Opin Pulm Med. 2004 Nov;10(6):489-94. doi: 10.1097/01.mcp.0000143691.94442.fa.

    PMID: 15510055BACKGROUND

  • 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.

    PMID: 11179121BACKGROUND

  • 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.

    PMID: 8621064BACKGROUND

  • 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.

    PMID: 2802378BACKGROUND

  • 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.

    PMID: 6901518BACKGROUND

  • 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.

    PMID: 12406837BACKGROUND

  • 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.

    PMID: 15961699BACKGROUND

  • 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.

    PMID: 17334259BACKGROUND

  • 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.

    PMID: 9804601BACKGROUND

  • 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.

    PMID: 1731573BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Karen J. Bosma, MD, FRCPC

    London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 3, 2011

First Posted

August 4, 2011

Study Start

April 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2011

Last Updated

August 15, 2012

Record last verified: 2012-08

Locations

CA(1)