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Sleep Quality in Mechanically Ventilated Patients

Primary Purpose

Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PAV
PSV
ACV
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring PAV (proportional assist ventilation); sleep; polysomnography; mechanical ventilation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • London Health Sciences Centre - University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

PAV

PSV

ACV

Arm Description

Proportional Assist Ventilation (PAV+ on PB840 ventilator)

Pressure Support Ventilation (PSV on PB840 ventilator)

Assist Control/ Pressure limited Ventilation (on PB840 ventilator)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Patient-ventilator asynchrony
Incidence of patient-ventilator asynchrony (asynchrony index, % of asynchronous breaths per minute)

Full Information

First Posted
August 3, 2011
Last Updated
August 13, 2012
Sponsor
Lawson Health Research Institute
Collaborators
Ontario Lung Association, Medtronic - MITG
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1. Study Identification

Unique Protocol Identification Number
NCT01410149
Brief Title
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

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Ontario Lung Association, Medtronic - MITG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
PAV (proportional assist ventilation); sleep; polysomnography; mechanical ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PAV
Arm Type
Active Comparator
Arm Description
Proportional Assist Ventilation (PAV+ on PB840 ventilator)
Arm Title
PSV
Arm Type
Active Comparator
Arm Description
Pressure Support Ventilation (PSV on PB840 ventilator)
Arm Title
ACV
Arm Type
Active Comparator
Arm Description
Assist Control/ Pressure limited Ventilation (on PB840 ventilator)
Intervention Type
Other
Intervention Name(s)
PAV
Intervention Description
Proportional Assist Ventilation will be used to ventilate the patient for a 24 hour period
Intervention Type
Other
Intervention Name(s)
PSV
Intervention Description
Pressure Support Ventilation will be used to ventilate the patient for a 24 hour period
Intervention Type
Other
Intervention Name(s)
ACV
Intervention Description
Assist Control Ventilation will be used to ventilate the patient for a 24 hour period
Primary Outcome Measure Information:
Title
Sleep quality
Description
Sleep fragmentation (number of arousals and awakenings/hr sleep), sleep architecture (% time asleep spent in Stage 1, 2, 3/4 and REM sleep)
Time Frame
3 nights
Secondary Outcome Measure Information:
Title
Patient-ventilator asynchrony
Description
Incidence of patient-ventilator asynchrony (asynchrony index, % of asynchronous breaths per minute)
Time Frame
3 nights
Other Pre-specified Outcome Measures:
Title
Delirium
Description
Positive score on a delirium screening tool (CAM-ICU or ICDSC)
Time Frame
3 days
Title
Comfort
Description
Patient's assessment of their own breathing comfort and their perceived quality of sleep, indicated on a visual analogue scale
Time Frame
3 days
Title
Respiratory pattern
Description
Measurement of average tidal volume, respiratory rate, minute ventilation and non-invasive measurement of respiratory muscle effort relative to maximum effort
Time Frame
3 nights
Title
Blood gas
Description
measurement of paO2 and paCO2
Time Frame
evening and morning

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen J. Bosma, MD, FRCPC
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre - University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
12598213
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.
Results Reference
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PubMed Identifier
15936695
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.
Results Reference
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PubMed Identifier
10713011
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. Erratum In: Chest 2001 Mar;119(3):993.
Results Reference
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PubMed Identifier
15510055
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.
Results Reference
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PubMed Identifier
11179121
Citation
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.
Results Reference
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PubMed Identifier
8621064
Citation
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Results Reference
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PubMed Identifier
2802378
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
17334259
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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Citation
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Citation
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Sleep Quality in Mechanically Ventilated Patients

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