Table 3

Specific quality criteria of included randomized trials

Reference

Inclusion criteria^a

Exclusion criteria

Baseline co-morbidity: AMI, COPD^b

Intervention in experimental group CPAP

Intervention in experimental group NPPV

Intervention in control group SMT^c

Objective criteria for endotracheal intubation^d

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)

^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.

Winck et al. Critical Care 2006 10:R69   doi:10.1186/cc4905