Esteban 1997.
| Methods | Multicentre RCT Setting: 27 medical‐surgical intensive care units in tertiary care hospital (two in Argentina, one in Brazil, 23 in Spain and one in Venezuela) Sample size: Estimated sample size was 220 patients in each comparison group to detect a 20% difference |
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| Participants | ‐ 484 patients had endotracheal tube received mechanical ventilation for more than 48 hours before the spontaneous breathing trial ‐ Male: 343; female: 141 ‐ Median age: 64 (51‐72) years ‐ Median SAPS II: 36 (29‐ 47) ‐ Median time of MV: 6 (4 ‐ 12) days There was no significant difference between comparison groups at baseline |
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| Interventions | 1‐ T‐tube circuit (n=246) 2‐ Pressure support ventilation of 7 cmH2O and PEEP ≤ 5 cmH20 (n=238) |
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| Outcomes | 1‐ ICU mortality 2‐ Hospital mortality 2‐ Successful weaning or extubation 3‐ Reintubation 4‐ Proportion requiring tracheostomy 5‐ Length of ICU stay 6‐ Length of hospital stay 7‐ Successful spontaneous breathing trial |
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| Notes | ‐ 28 patients were excluded from the analysis because of missing data, before randomization ‐ PSV and T‐Tube: The extubation was performed after the 2 hours trial of spontaneous breathing ‐ The outcomes were measured in two groups: 1‐ patients who fulfilled 2 hours trial and 2‐ patients who had signs of poor tolerance in the 2 hours trial ‐ The length of ICU and hospital stay were reported as medians in 'Additional tables' |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Patients were randomly assigned using a random‐number table by permuted blocks according to the study centre |
| Allocation concealment (selection bias) | Low risk | The patients were allocated to the two groups in a blinded fashion with the use of opaque, sealed, numbered envelopes, which were opened only when a patient fulfilled all of the inclusion criteria |
| Selective reporting (reporting bias) | Low risk | Outcomes were clinically relevant to evaluate the effectiveness and safety of both weaning strategies |
| Other bias | Low risk | None suspected |
| Free of detection bias ? | Low risk | The first author reported by email: assessors were distinct from study researchers or blinded to the assignments |
| Free of attrition bias? | Low risk | The patients flow was clear and there was no withdrawal after randomization |