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flávia maria ribeiro vital efetividade e segurança da - Unifesp

flávia maria ribeiro vital efetividade e segurança da - Unifesp

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Apêndice<br />

of therapy, treatment failure, complications, increase in frequence of acute<br />

myocardial infarction, compliance of patients in accepting the NPPV.<br />

Criteria for considering studies for this review<br />

Types of studies<br />

Studies will only be included if they are randomised controlled trials (RCT) or<br />

quasi-randomised controlled trials (QRCT) with or without blinding (although<br />

blinding seems unlikely to be feasible). QRCT are those studies in which the<br />

allocation procedure is unlikely to be adequately concealed, such as coin flips, oddeven<br />

numbers or according to patient social security numbers, <strong>da</strong>ys of the week or<br />

medical record numbers.<br />

Types of participants<br />

Only studies of adult subjects with acute or acute on chronic cardiogenic<br />

pulmonary oedema will be included in this review. All subjects must have the<br />

diagnosis of cardiogenic pulmonary oedema using internationally accepted criteria<br />

such as those by the American Heart Association (ACC/AHA 1995) or European<br />

Society of Cardiology (Nieminen 2005).<br />

The diagnosis of AHF is based on the symptoms and clinical findings such as:<br />

dyspnoea, shortness of breath (dry cough, sometimes with frothy sputum), pallor<br />

or even cyanosis, cold clammy skin, and normal or elevated blood pressure. Fine<br />

rales are usually audible over the lung fields. This should be supported by<br />

appropriate investigations such as ECG, chest X-ray (to show pulmonary<br />

congestion/oedema), biomarkers, and Doppler-echocardiography.<br />

Trials where subjects have a primary diagnosis of pneumonia, or other<br />

underlying pathologies, and weaning studies will not be considered for inclusion in<br />

this review.<br />

Types of intervention<br />

Intervention: stan<strong>da</strong>rd medical care (SMC) (ACC/AHA 1995) for the<br />

management of cardiogenic pulmonary oedema plus NPPV (CPAP or Bi-level)<br />

applied through a nasal or facemask.<br />

The control group may include any form of stan<strong>da</strong>rd therapy for the<br />

management of cardiogenic pulmonary oedema, but which does not involve NPPV<br />

or any other kind of ventilatory support .<br />

Types of outcome measures<br />

Primary outcome measure:<br />

• Hospital mortality.<br />

Secon<strong>da</strong>ry outcome measures:

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