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. 2006 Apr 28;10(2):R69. doi: 10.1186/cc4905

Table 2.

General characteristics and general quality criteria of randomized trials in acute cardiogenic pulmonary edema patients included in the study

Reference Country and Setting Sample size Interventions Outcomes analyzed Randomization assignment concealmenta Objective selection criteriab Blindingc Standardization of co-interventionsd Intention-to-treat analysise Complete follow-up detailsf Outcome definitiong
Rasanen et al. 1985 [62] Finland: ED and ICU 40 SMT vs CPAP Meeting criteria for ETI during 3 h follow-up; in-hospital mortality Adequate Yes NR Yes Adequate Yes Adequate
Bersten et al. 1991 [63] Australia: ICU 39 SMT vs CPAP Meeting criteria for ETI during 24 h follow-up; in-hospital mortality Uncertain Yes No Yes Uncertain Yes Adequate
Lin et al. 1995 [57] Taiwan: ICU 100 SMT vs CPAP Meeting criteria for ETI during 6 h follow-up; in-hospital mortality Uncertain Yes NR Yes Adequate Yes Adequate
Takeda et al. 1997 [11] Japan: CU 30 SMT vs CPAP Meeting criteria for ETI during 24 h follow-up; in-hospital mortality Uncertain Yes NR Yes Adequate Yes Adequate
Takeda et al. 1998 [12] Japan: CU 22 SMT vs CPAP Meeting criteria for ETI during 48 h follow-up; in-hospital mortality Adequate Yes NR Yes Adequate Yes Adequate
Kelly et al. 2002 [16] Scotland, UK: ED and HDU 58 SMT vs CPAP Meeting criteria for treatment failure; in-hospital mortality Adequate Yes NR Yes Adequate Yes Inadequate
L'Her et al. 2004 [22] France: ED 89 SMT vs CPAP Meeting criteria for ETI or death during 48 h follow-up; in-hospital mortality Adequate Yes NR Yes Adequate Yes Adequate
Masip et al. 2000 [13] Spain: ED and ICU 37 SMT vs NPPV Meeting criteria for ETI during 10 h follow-up; in-hospital mortality; AMI incidence Adequate Yes No Yes Uncertain Yes Adequate
Levitt et al. 2001 [14] USA: ED 38 SMT vs NPPV ETI decided by attending physician during 24 h follow-up; in-hospital mortality; AMI incidence. Adequate Yes NR Uncertain Uncertain Yes Uncertain
Nava et al. 2003 [19] Italy: ED 130 SMT vs NPPV Meeting criteria for ETI during 24 h follow-up; in-hospital mortality; AMI incidence Adequate Yes NR Yes Adequate Yes Adequate
Mehta et al. 1997 [25] USA: ED 27 CPAP vs NPPV ETI decided by attending physician during 24 h follow-up; in-hospital mortality; AMI incidence Adequate Yes Yesh Yes Adequate Yes Uncertain
Martin-Bermudez et al. 2002 [17] Spain: ED 80 CPAP vs NPPV Meeting criteria for ETI during 24 h follow-up; in-hospital mortality; AMI incidence Uncertain Yes NR Uncertain Adequate Yes Uncertain
Bellone et al. 2004 [20] Italy: ED 46 CPAP vs NPPV Meeting criteria for ETI during 36 h follow-up; in-hospital mortality; AMI incidence Adequate Yes No Yes Adequate Yes Adequate
Bellone et al. 2005 [24] Italy: ED 36 CPAP vs NPPV Meeting criteria for ETI during 36 h follow-up; in-hospital mortality Adequate Yes No Yes Adequate Yes Adequate
Park et al. 2001 [15] Brazil: ED 26 SMT vs CPAP vs NPPV ETI decided by attending physician during 1 h follow-up; in-hospital mortality; AMI incidence Uncertain Yes NR Yes Uncertain Yes Inadequate
Park et al. 2004 [23] Brazil: ED 80 SMT vs CPAP vs NPPV ETI decided by attending physician during 24 h follow-up; in-hospital mortality; AMI incidence Adequate Yes NR Yes Adequate Yes Uncertain
Crane et al. 2004 [21] UK: ED 60 SMT vs CPAP vs NPPV Meeting criteria for ETI during 2 h follow-up; in-hospital mortality; AMI incidence Adequate Yes No Yes Adequate Yes Adequate

aClassified as: adequate, inadequate or uncertain. bClassified as: yes, if inclusion and exclusion criteria for participants are adequately reported; no, if selection criteria are not reported. cClassified as: yes, for articles that implemented blinding at any level; no, for articles reporting not being able to implement blinding of interventions at any level; not reported (NR), for articles that do not make any mention to blinding. dClassified as: yes, if there was an attempt to standardize treatment and care besides the assigned interventions; no, if no attempt to standardize was applied; uncertain, if it was not clearly reported. eClassified as: adequate; inadequate; uncertain. fClassified as: yes; no; not reported (NR). gClassified as: adequate if objective criteria for endotracheal intubation were defined; inadequate if the criteria were not defined; and uncertain if criteria application was unclear (for example, depending on attending physician). hIn this study physicians, nurses and patients were blinded by covering the control panel on the device. AMI, acute myocardial infarction; CPAP, continuous positive airway pressure; CU, coronary unit; ED, emergency department; ETI, endotracheal intubation; HDU, high dependency unit; ICU, intensive care unit; NPPV, non-invasive pressure ventilation; SMT, standard medical therapy.