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Table 3 Specific quality criteria of included randomized trials

From: Efficacy and safety of non-invasive ventilation in the treatment of acute cardiogenic pulmonary edema – a systematic review and meta-analysis

Reference

Inclusion criteriaa

Exclusion criteria

Baseline co-morbidity: AMI, COPDb

Intervention in experimental group CPAP

Intervention in experimental group NPPV

Intervention in control group SMTc

Objective criteria for endotracheal intubationd

Rasanen et al. 1985 [62]

Clinical criteria of APE; RR >25/min; PaO2/FiO2 <200

COPD; unresponsive; unable to maintain patent airway; lung infection; pulmonary embolism

AMI: control 10/20; CPAP 9/20 COPD: none

CPAP 10 cmH2O face mask plus medical therapy

-

SMT

Adequate Criteria for ETI: PaO2<50 mmHg; PaCO2 > 55 mmHg; RR >35/min; unresponsiveness; airway obstruction

Bersten et al. 1991 [63]

Clinical criteria of APE; PaO2 < 70 mmHg; PaCO2 > 45 mmHg when O2 8 l/min

AMI and shock; SBP <90 mmHg; stenotic VHD; COPD and CO2 retention

AMI: control 4/20; CPAP 3/19 COPD: none

CPAP 10 cmH2O face mask plus medical therapy

-

SMT

Adequate Criteria for ETI: clinical deterioration; PaO2 < 70 mmHg with O2 100%; PaCO2 > 55 mmHg

Lin et al. 1995 [57]

Clinical criteria of APE; PaO2/FIO2 = 200–400; P [A-a] O2 > 250 mmHg

Unresponsive; unable to maintain patent airway; shock; septal rupture; stenotic VHD; COPD and CO2 retention

AMI: control 11/50; CPAP 10/50 COPD: none

CPAP face mask titrated up – 2.5, 5, 7.5, 10 and 12.5 cmH2O plus medical therapy

-

SMT (plus dopamine)

Adequate Criteria for ETI: cardiac resuscitation or clinical deterioration and two of the following – PaCO2 > 55 mmHg, PaO2/FiO2 < 200 mmHg, RR >35

Takeda et al. 1997 [11]

Clinical criteria of APE; respiratory distress; PaO2 < 80 mmHg while receiving ≥50% O2

Not reported

AMI: CPAP 5/15; Control 6/15 COPD: none

CPAP 4–10 cmH2O nasal mask plus medical therapy

-

SMT (plus dopamine, dobutamine, norepinephrine and digitalis)

Adequate Criteria for ETI: clinical deterioration and PaO2/FiO2 <100 mmHg (with FiO2 ≥70%), PaCO2 >55 mmHg

Takeda et al. 1998 [12]

Clinical criteria of APE; PaO2 < 80 mmHg

Shock; septal or ventricular rupture

All 22 patients with AMI admitted to the coronary unit

CPAP 4–10 cmH2O nasal mask plus medical therapy

-

SMT (plus dopamine, dobutamine, norepinephrine)

Adequate Criteria for ETI: clinical deterioration and PaO2/FiO2 <100 mmHg (with FiO2 ≥70%) PaCO2 >55 mmHg

Kelly et al. 2002 [16]

Clinical criteria of APE; RR > 20/min

Pneumonia; pneumothorax; pre-hospital treatment with interventions other than oxygen, diuretics or opiates

AMI: not reported COPD: not reported

CPAP 7.5 cmH2O face mask plus medical therapy

-

SMT

Inadequate Criteria for treatment failure: need for intubation (no defined criteria), hypoxemia or hypercapnia and respiratory distress

L'Her, et al. 2004 [22]

Clinical criteria of APE Age >75 years; PaO2/FiO2 <300 mmHg, RR >25/min

GCS <7; Sat O2 <85%; SBP <90 mmHg); chronic respiratory insufficiency

AMI: not reported (acute ischemic heart disease: control 6/46; CPAP 7/43) COPD: none

Face mask CPAP 7.5 cmH2O plus medical therapy

-

SMT

Adequate Serious complications considered as death or need for ETI within 48 h. Criteria for ETI: cardiac or respiratory arrest; SBP <80 mmHg; progressive hypoxemia (Sat O2 <92%); coma or seizures; agitation

Masip et al. 2000 [13]

Clinical criteria of APE

AMI; pneumonia; SBP <90 mmHg; CRF; immediate intubation; neurological deterioration

AMI: control 6/18; NPPV 5/19 COPD: control 7/18; NPPV 3/19

-

NPPV face mask, PEEP 5 cmH2O, plus medical therapy PSV 15.2 ± 2.4 cmH2O

SMT

Adequate Criteria for ETI: cardiac or respiratory arrest, hypoxemia (Sat O2 <80%) and muscles fatigue

Levitt et al. 2001 [14]

Clinical criteria of APE; RR >30/min

Immediate need for intubation; radiograph not compatible with APE

AMI: none COPD: not reported

-

NPPV S/T mode, face or nasal mask, initial IPAP of 8 and EPAP of 3 cmH2O, pressure support of 5 cmH2O plus medical therapy PSV 5.0 cmH2O

SMT

Uncertain Decision by attending physician based on the following criteria: respiratory distress, deterioration in mental status or vital signs, PaO2 <60 mmHg, PaCO2 >50 mmHg

Nava et al. 2003 [19]

Clinical criteria of APE; PaO2/FiO2 < 250; RR >30/min

AMI needing thrombolysis; immediate need for intubation; Kelly score >3; shock; arrhythmias; SpO2<80%; severe CRF; pneumothorax

AMI: control 11/65; NPPV 11/65 COPD: control 26/65; NPPV 27/65

-

NPPV S mode face mask IPAP 14.5 ± 21.1 cmH2O, EPAP: 6.1 ± 3.2 cmH2O plus medical therapy PSV 8.4 cmH2O

SMT

Adequate Sat O2 <85% with FiO2 100%, cardiac or respiratory arrest, inability to tolerate mask, PaCO2 >50 mmHg, signs of pump exhaustion, SBP <90 mmHg, AMI, massive GI bleeding

Mehta et al. 1997 [25]

Clinical criteria of APE; RR >30/min; tachycardia >100 bpm; without pulmonary aspiration or infection

Immediate need for intubation; respiratory or cardiac arrest; arrhythmias; SBP <90 mmHg; unresponsive; agitated; condition precluding use of face mask

AMI: CPAP 1/13; NPPV 1/14 Chest pain: CPAP 4/13; NPPV 10/14; COPD: not reported

CPAP 10 cmH2O nose/face mask plus medical therapy

NPPV S/T mode, nasal/face mask, IPAP 15 cmH2O, EPAP 5 cmH2O, plus medical therapy PSV 10.0 cmH2O

-

Uncertain Decision by attending physician based on the following criteria: severe respiratory distress, inability to tolerate mask, unstable vital signs, PaO2 <60 mmHg or increase PaCO2 >5 mmHg

Martin-Bermudez, et al. 2002 [17]

Clinical criteria of APE; RR >25/min; Sat O2 <90%

Not reported

AMI: not reported COPD: not reported

Face mask CPAP plus medical therapy

Face mask NPPV plus medical therapy PSV uncertain

-

Uncertain

Bellone et al. 2004 [20]

Clinical criteria of APE; Sat O2 <90%; RR >30/min

Acute coronary syndrome; immediate need for intubation; respiratory or cardiac arrest; SBP <90 mmHg; unresponsive, agitated or unable to cooperate; condition precluding use of face mask

AMI: none COPD: CPAP 8/22; NPPV 6/24

Face mask CPAP 10 cmH2O plus medical therapy

Face mask NPPV initially IPAP 15 cmH2O and EPAP 5 cmH2O, with adjustments as needed to obtain tidal volume >400 ml plus medical therapy PSV 10.0 cmH2O

-

Adequate Respiratory arrest; loss of consciousness; agitation; heart rate <50/min, SBP <70 mmHg

Bellone et al. 2005 [24]

Clinical criteria of APE; PaCO2 > 45 mmHg; Sat O2 <90%; RR >30/min

COPD; PaCO2 <45 mmHg; immediate need for intubation; respiratory or cardiac arrest; SBP <90 mmHg; CRF; agitated; condition precluding use of face mask; enrolled in other study

AMI: CPAP 0/18; NPPV 2/18 COPD: none

Face mask CPAP 10 cmH2O plus medical therapy

Face mask NPPV initially IPAP 15 cmH2O, EPAP 5 cmH2O, adjustments to obtain tidal volume >400 ml plus medical therapy PSV 10.0 cmH2O

-

Adequate Respiratory arrest; loss of consciousness; agitation; heart rate <50/min, SBP <70 mmHg

Park et al. 2001 [15]

Clinical criteria of APE; RR >25/min

COPD; SBP <90 mmHg; arrhythmias; bradypnea; unresponsive, agitated or unable to cooperate; vomiting; digestive hemorrhage; facial deformities

AMI: control 2/10; CPAP 1/9; NPPV 1/7 COPD: none

Face mask CPAP mean 7.5 cmH2O, initially 5, increased by 2.5, maximum 12.5 cmH2O, plus medical therapy

NPPV S/T mode nasal mask, IPAP 12 cmH2O, EPAP 4 cmH2O, plus medical therapy PSV 8.0 cmH2O

SMT

Inadequate Decision made by the attending physician based on clinical and laboratory findings

Park et al. 2004 [23]

Clinical criteria of APE; RR >25/min

AMI; COPD; pulmonary embolism; pneumonia; pneumothorax; SBP <90 mmHg; vomiting

AMI: control 3/26; CPAP 1/27; NPPV 1/27 COPD: none

Face mask CPAP initially 11 ± 2 cmH2O plus medical therapy

Face mask NPPV, IPAP 17 ± 2 cmH2O, EPAP 11 ± 2 cmH2O, plus medical therapy PSV 6.0 cmH2O

SMT

Uncertain Decision made by the attending physician based on the following criteria: GCS <13, respiratory distress, PaO2 <60 mmHg, Sat O2 <90%, increase PaCO2 >5 mmHg

Crane et al. 2004 [21]

Clinical criteria of APE; RR >23/min; pH <7.35

SBP <90 mmHg; temperature >38°C; AMI with thrombolysis; dialysis for CRF; impaired consciousness; dementia

AMI: none COPD: control 6/20; CPAP 3/20; NPPV 7/20

Face mask CPAP 10 cmH O plus medical therapy

Face mask NPPV IPAP 15 cmH2O, EPAP 5 cmH2O plus medical therapy PSV 10.0 cmH2O

SMT

Adequate RR >40 or <10 and reduced consciousness; falling pH (<7.2)

  1. aClinical criteria of APE: existence of dyspnea of sudden onset, bilateral pulmonary infiltrates on chest radiograph and a compatible physical examination (bilateral crackles on pulmonary auscultation, elevated jugular venous pressure, third heart sound on cardiac auscultation). bData on baseline frequency of acute myocardial infarction (AMI) and chronic obstructive pulmonary disease (COPD) are presented as number of patients with co-morbidity/total number of patients in the assigned group. cStandard medical therapy was defined as: O2 by face mask, nitro-glycerin, nitroprusside, furosemide and morphine. Other interventions described in managing these patients will be specifically indicated. dClassified 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). APE, acute pulmonary edema; bpm, beats per minute; CPAP, continuous positive airway pressure; CRF, chronic renal failure; DBP, diastolic blood pressure; EPAP, expiratory positive airway pressure; ETI, endotracheal intubation; FiO2, O2 inspired fraction; GI, Gastrointestinal; GCS, Glasgow coma scale; IPAP, inspiratory positive airway pressure; NPPV, non-invasive pressure ventilation; P [A-a], arterial/alveolar partial pressure differential; PaCO2, CO2 partial pressure; PaO2, O2 partial pressure; PEEP, positive end expiratory pressure; PSV, pressure support ventilation; RR, respiratory rate; Sat O2, O2 saturation; SBP, systolic blood pressure; S mode, spontaneous mode; SMT, standard medical therapy; SpO2, pulse oximetry oxygen saturation; S/T mode, spontaneous/timed mode; VHD, valvular heart disease.
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