Sleep Quality in Mechanically Ventilated Patients

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01410149
• Other study ID #: R-07-106
• Secondary ID: 13114
• Status: Completed
• Phase: N/A
• First received: August 3, 2011
• Last updated: August 13, 2012
• Start date: April 2007
• Est. completion date: December 2011

Study information

• Verified date: August 2012
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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 order. The purpose is to determine the effect of mode of mechanical ventilation on patient-ventilator asynchrony and sleep quality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• 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

Locations

Country	Name	City	State
Canada	London Health Sciences Centre - University Hospital	London	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Medtronic - MITG, Ontario Lung Association

Country where clinical trial is conducted

Canada, 

References & Publications (13)

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. — View Citation

Chen HI, Tang YR. Sleep loss impairs inspiratory muscle endurance. Am Rev Respir Dis. 1989 Oct;140(4):907-9. — View 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. Erratum in: Chest 2001 Mar;119(3):993. — View Citation

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. — View 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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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

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

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Delirium	Positive score on a delirium screening tool (CAM-ICU or ICDSC)	3 days	No
Other	Comfort	Patient's assessment of their own breathing comfort and their perceived quality of sleep, indicated on a visual analogue scale	3 days	No
Other	Respiratory pattern	Measurement of average tidal volume, respiratory rate, minute ventilation and non-invasive measurement of respiratory muscle effort relative to maximum effort	3 nights	No
Other	Blood gas	measurement of paO2 and paCO2	evening and morning	No
Primary	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	No
Secondary	Patient-ventilator asynchrony	Incidence of patient-ventilator asynchrony (asynchrony index, % of asynchronous breaths per minute)	3 nights	No