Table 2.
Reported outcomes in select placebo-controlled randomized clinical trials in acute respiratory failure and PARDS.
| Trial | Years | Intervention | Total subjects | Primary outcome | Other reported outcomes | Reference |
|---|---|---|---|---|---|---|
| HFOV | 1990–1994 | HFOV versus conventional | 58 | Mortality (34% HFOV; 41% conventional) | Ventilator days in survivors; supplemental O2 requirement; chronic lung disease | (24) |
| Weaning protocol | 1999–2001 | Protocolized PSV or VSV versus no protocol | 179 | Days to extubation (median 2 for no protocol; 1.6 PSV; 1.8 VSV) | Successful extubation | (25) |
| Calfactant | 2000–2003 | Intratracheal calfactant versus air placebo | 152 | VFD (13 ± 8 for calfactant; 12 ± 11 for air) | Mortality; failure of conventional ventilation; oxygenation; supplemental O2 requirement; PICU and hospital LOS | (26) |
| Prone position | 2001–2004 | Prone versus supine position | 101 | VFD (16 ± 8 for supine; 16 ± 8 for prone) | Mortality; organ failure-free days; supplemental O2 requirement; PCPC; POPC | (27) |
| Inhaled nitric oxide | 2003–2005 | iNO versus nitrogen placebo | 53 | VFD (15 ± 8 for iNO; 9 ± 9 for placebo) | Mortality; ECMO/death | (28) |
| Lucinactant | 2007–2010 | Intratracheal lucinactant versus air placebo | 165 | Adjusted LSM of ventilator days (4 for lucinactant; 4.5 for air) | Mortality; VFD; PICU and hospital LOS | (29) |
| PED-CARDS | 2008–2010 | Intratracheal calfactant versus air placebo | 109 | Mortality (12% for calfactant; 9% for air) | VFD; oxygenation; PICU and hospital LOS | (30) |
| RESTORE | 2009–2013 | Protocolized sedation versus usual care | 2449 | Ventilator days (median 6.5 for protocol; 6.5 for usual care) | Mortality; duration of weaning; duration of non-invasive ventilation; PICU and hospital LOS | (31) |
| Steroids | 2010–2014 | Methylprednisolone versus placebo | 35 | Ventilator days (10 ± 7 for steroids; 10 ± 5 for placebo) | Mortality; VFD; oxygenation; PICU and hospital LOS | (32) |
ECMO, extracorporeal membrane oxygenation; HFOV, high-frequency oscillatory ventilation; LSM, least squares means; LOS, length of stay; PCPC, pediatric cerebral performance category; PED-CARDS, pediatric calfactant in acute respiratory distress syndrome; POPC, pediatric overall performance category; PICU, pediatric intensive care unit; PSV, pressure-support ventilation; RESTORE, randomized evaluation of sedation titration for respiratory failure; VFD, ventilator-free days; VSV, volume support ventilation.