Rose 2008.
| Methods | Single centre randomized controlled trial | |
| Participants | 102 adult patients (51 intervention: 51 control) requiring > 24 hours of mechanical ventilation on a mandatory ventilator mode. Patients tolerating PSV within 24 hours of ventilation were excluded. Other eligibility criteria included: PEEP ≤ 8 cmH2O, PaO2/FiO2 ratio >150 or SaO2 ≥ 90% with FiO2 ≤ 0.5, plateau pressure ≤ 30 cmH2O, haemodynamic stability, peripheral body temperature 36‐39 C, stable neurological status with GCS >4, and no anticipated (within 2 hours) for transport or surgery).Final study inclusion criterion was completion of 30 minute SBT to determine tolerance of pressure support. Exclusion criteria: no SmartCare/PS™ enabled ventilator available, CNS disorder with anticipated poor outcome. Setting: Australia, 390 bed acute tertiary referral hospital with 100,000 admissions/annum, 24 bed mixed medical/surgical/trauma ICU. Nurse:patient ratio 1:1, 9 intensivists providing twice daily structured rounds supported by 26 hospital medical officers (registrars and residents) |
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| Interventions | Intervention: SmartCare/PS™. Extubation remained at the discretion of the attending clinician Control: clinicians instructed to wean PS and PEEP according to usual local practice in the absence of formal guidelines. Clinicians were instructed to wean PS as able with no constraints as to the frequency or size of PS adjustment while maintaining patients in the same zone of comfort as described for SmartCare/PS™. Extubation remained at the discretion of the attending clinician |
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| Outcomes | Time to separation defined as time in hours from randomization to separation potential Total duration of weaning defined as time from randomization to successful extubation Time from intubation to first extubation Time from intubation to successful extubation ICU length of stay Hospital length of stay ICU mortality Reintubation Post‐extubation NIV |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated block randomization |
| Allocation concealment (selection bias) | Low risk | Sequential opaque envelopes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition reported, analysis according to ITT, no missing outcome data |
| Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes are reported |
| Other bias | Low risk | No other sources of bias detected |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Personnel not blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assumed as low risk due to the objective nature of outcomes (weaning commencement/extubation). Outcome assessor was independent from those managing care |