Respiratory FailureNCT01410149

Sleep Quality in Mechanically Ventilated Patients

A study testing PAV, PSV and ACV in people with Respiratory Failure, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Respiratory Failure
What is being tested?: PAV, PSV and ACV
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteCanada
Study dates: Apr 2007to Dec 2011
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

Other trials in Canada

About this study

Official title: The Influence of Mode and Patient-ventilator Interaction on Sleep Quality in the ICU

Conditions: Respiratory Failure
Being tested: PAV, PSV, ACV
Keywords: PAV (proportional assist ventilation); sleep; polysomnography; mechanical ventilation
Medical subject headings: Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PAVOther
Proportional Assist Ventilation will be used to ventilate the patient for a 24 hour period
PSVOther
Pressure Support Ventilation will be used to ventilate the patient for a 24 hour period
ACVOther
Assist Control Ventilation will be used to ventilate the patient for a 24 hour period

Study groups in NCT01410149
Study group	Role	What they receive
PAV	Active comparator	Proportional Assist Ventilation (PAV+ on PB840 ventilator) Receives: Other: PAV
PSV	Active comparator	Pressure Support Ventilation (PSV on PB840 ventilator) Receives: Other: PSV
ACV	Active comparator	Assist Control/ Pressure limited Ventilation (on PB840 ventilator) Receives: Other: ACV

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 3 nights

Secondary outcomes (1)

Patient-ventilator asynchrony
Incidence of patient-ventilator asynchrony (asynchrony index, % of asynchronous breaths per minute)
Measured: 3 nights

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2007Dec 2011

First posted4 Aug 2011 (estimated)
Study startApr 2007
Primary completionDec 2010
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Respiratory FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01410149
Sponsor's protocol ID: R-07-106
Other IDs: 13114
Status last verified: Aug 2012
First submitted: 3 Aug 2011
Last updated: 15 Aug 2012
Results posted: No
Data monitoring committee: No

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. doi: 10.1164/rccm.2201090.
PubMed 12598213
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.
PubMed 15936695
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.
PubMed 10713011
Parthasarathy S. Sleep during mechanical ventilation. Curr Opin Pulm Med. 2004 Nov;10(6):489-94. doi: 10.1097/01.mcp.0000143691.94442.fa.
PubMed 15510055
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.
PubMed 11179121
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.
PubMed 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.
PubMed 2802378
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.
PubMed 6901518
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.
PubMed 12406837
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.
PubMed 15961699
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.
PubMed 17334259
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.
PubMed 9804601
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.
PubMed 1731573

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Diaphragm Response in Elderly for Acute Monitoring
Acute Dyspnea, Acute Respiratory Failure
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 3
A Clinical Study of Sotatercept (MK-7962) in People With Combined Postcapillary and Precapillary Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (MK-7962-041)
Pulmonary Hypertension
Not yet recruiting
Modified Inhaled Nitric Oxide in Ventilated Patients With Acute Respiratory Failure
Acute Respiratory Failure (ARF), Nitric Oxide
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position

All Respiratory Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Influence of Mode and Patient-ventilator Interaction on Sleep Quality in the ICU
ClinicalTrials.gov ID: NCT01410149
Acronym / sponsor ID: R-07-106
Conditions: Respiratory Failure
Keywords: PAV (proportional assist ventilation); sleep; polysomnography; mechanical ventilation
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
Collaborators: Ontario Lung Association, Medtronic - MITG
Study start: Apr 2007
Primary completion: Dec 2010 (actual)
Study completion: Dec 2011 (actual)
First posted: 4 Aug 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
PAV	Active comparator	Other: PAVProportional Assist Ventilation (PAV+ on PB840 ventilator)
PSV	Active comparator	Other: PSVPressure Support Ventilation (PSV on PB840 ventilator)
ACV	Active comparator	Other: ACVAssist Control/ Pressure limited Ventilation (on PB840 ventilator)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PAVProportional Assist Ventilation will be used to ventilate the patient for a 24 hour period	Other	PAV
PSVPressure Support Ventilation will be used to ventilate the patient for a 24 hour period	Other	PSV
ACVAssist Control Ventilation will be used to ventilate the patient for a 24 hour period	Other	ACV

Primary outcome

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

1 secondary outcome

Patient-ventilator asynchrony
Time frame: 3 nights

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2012.
Background: PubMed 12598213Gabor 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.
Background: PubMed 15936695Parthasarathy 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.
Background: PubMed 10713011Cooper 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.
Background: PubMed 15510055Parthasarathy S. Sleep during mechanical ventilation. Curr Opin Pulm Med. 2004 Nov;10(6):489-94. doi: 10.1097/01.mcp.0000143691.94442.fa.
Background: PubMed 11179121Freedman 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.
Background: PubMed 8621064Irwin 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.
Background: PubMed 2802378Chen 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.
Background: PubMed 6901518Helton 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.
Background: PubMed 12406837Parthasarathy 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.
Background: PubMed 15961699Fanfulla 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.
Background: PubMed 17334259Bosma 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.
Background: PubMed 9804601Meza 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.

Related trials for Respiratory Failure

Not yet recruitingObservational study
Diaphragm Response in Elderly for Acute Monitoring
Acute Dyspnea, Acute Respiratory Failure
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 3
A Clinical Study of Sotatercept (MK-7962) in People With Combined Postcapillary and Precapillary Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (MK-7962-041)
Pulmonary Hypertension
Not yet recruiting
Modified Inhaled Nitric Oxide in Ventilated Patients With Acute Respiratory Failure
Acute Respiratory Failure (ARF), Nitric Oxide
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Karen J. Bosma, MD, FRCPC principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PAV, PSV and ACV in people with Respiratory Failure, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep quality (time frame: 3 nights). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01410149, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2012.