Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
400 participants
INTERVENTIONAL
2013-08-31
2015-12-31
Brief Summary
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After the interventions, the investigators will evaluate if there are reduced days of hospital admission, major cardiovascular events (infarction, reinfarction, heart failure and stroke) and overall mortality.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CPAP
Patients with apnea will be treated with CPAP during the night.
CPAP
CPAP - continuous positive air pressure in patients with sleep apnea
Control
One arm group will be control and will not receive CPAP treatment during the ICU admission.
No interventions assigned to this group
Interventions
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CPAP
CPAP - continuous positive air pressure in patients with sleep apnea
Eligibility Criteria
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Inclusion Criteria
* Acute decompensated heart failure
* Age \> 18 years-old
* Cardiology intensive care unit admission
Exclusion Criteria
* Invasive mechanical ventilation
* hemodynamic instability
* use of intravenous vasoactive drugs
* acute respiratory failure
18 Years
ALL
No
Sponsors
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Associação Fundo de Incentivo à Pesquisa
OTHER
Responsible Party
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Fatima Dumas Cintra
MD, PhD
Locations
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Hospital Sao Paulo - Federal University of Sao Paulo
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Fatima Cintra, MD, PhD
Role: primary
References
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Freedman NS, Kotzer N, Schwab RJ. Patient perception of sleep quality and etiology of sleep disruption in the intensive care unit. Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1155-62. doi: 10.1164/ajrccm.159.4.9806141.
Richards KC, O'Sullivan PS, Phillips RL. Measurement of sleep in critically ill patients. J Nurs Meas. 2000 Fall-Winter;8(2):131-44.
Aaron JN, Carlisle CC, Carskadon MA, Meyer TJ, Hill NS, Millman RP. Environmental noise as a cause of sleep disruption in an intermediate respiratory care unit. Sleep. 1996 Nov;19(9):707-10. doi: 10.1093/sleep/19.9.707.
Gami AS, Olson EJ, Shen WK, Wright RS, Ballman KV, Hodge DO, Herges RM, Howard DE, Somers VK. Obstructive sleep apnea and the risk of sudden cardiac death: a longitudinal study of 10,701 adults. J Am Coll Cardiol. 2013 Aug 13;62(7):610-6. doi: 10.1016/j.jacc.2013.04.080. Epub 2013 Jun 13.
Martinez-Garcia MA, Campos-Rodriguez F, Catalan-Serra P, Soler-Cataluna JJ, Almeida-Gonzalez C, De la Cruz Moron I, Duran-Cantolla J, Montserrat JM. Cardiovascular mortality in obstructive sleep apnea in the elderly: role of long-term continuous positive airway pressure treatment: a prospective observational study. Am J Respir Crit Care Med. 2012 Nov 1;186(9):909-16. doi: 10.1164/rccm.201203-0448OC. Epub 2012 Sep 13.
Elliott R, McKinley S, Cistulli P. The quality and duration of sleep in the intensive care setting: an integrative review. Int J Nurs Stud. 2011 Mar;48(3):384-400. doi: 10.1016/j.ijnurstu.2010.11.006. Epub 2010 Dec 24.
Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7.
Other Identifiers
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AFIP
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
bedsidesleep
Identifier Type: -
Identifier Source: org_study_id