Summary of findings for the main comparison. BIS monitoring compared to clinical assessment for sedation in mechanically ventilated adults in the intensive care unit and its impact on clinical outcomes and resource utilization.
| BIS monitoring compared to clinical assessment for sedation in mechanically ventilated adults in the intensive care unit and its impact on clinical outcomes and resource utilization | ||||||
| Patient or population: Mechanically ventilated adults in the intensive care unit Setting: Medical and surgical patients in intensive care unit in hospitals in China, Japan and Australia Intervention: BIS monitoring Comparison: Clinical assessment | ||||||
| Outcomes | Anticipated absolute effects* | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with Clinical assessment | Risk with BIS monitoring | |||||
| Intensive care unit length of stay (ICU LOS) (measured in days) | Median ICU LOS was 8 Days | Median ICU LOS was 4 Days higher | Mdn D 4 [Range 4 to 18] | 50 (1 RCT) | ⊕⊕⊕⊝ LOW 1 | |
| Duration of mechanical ventilation (measured in days) | Mean duration of mechanical ventilation was 2.49 days | Mean duration of mechanical ventilation was 0.02 days lower | MD ‐0.02 (‐0.13, 0.09) | 155 (2 RCTs) | ⊕⊕⊝⊝ LOW 2 | |
| Adverse events: Measured as number of patients with adverse events | 105 (1 RCT) |
⊕⊝⊝⊝ VERY LOW 3 | Clinically relevant adverse events such as self‐extubation or unplanned disconnection of indwelling catheters were not reported in any study. | |||
| 809 patients with restlessness after suction per 1000 patients | 16 less patients with restlessness after suction | RR 1.11 (0.90,1.37) | ||||
| 714 patients with endotracheal tube resistance per 1000 patients | 32 more patients with endotracheal tube resistance | RR 0.96 (0.75, 1.22) | ||||
| 928 patients with pain tolerance during sedation per 1000 patients | 8 more patients with pain tolerance during sedation | RR 0.99 (0.89, 1.10) | ||||
| 47 patients with delirium after extubation per 1000 patients | 32 less patients with delirium after extubation | RR 3 (0.28, 32.04) | ||||
| Other important secondary outcomes like Any‐cause mortality, ventilator‐associated pneumonia, hospital LOS, amount of sedative agents used, long term functional outcomes and quality of life were not reported in any studies | ||||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). Mdn D: Median difference; CI: Confidence interval; RR: Risk ratio; OR: Odds ratio; | ||||||
| GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
1 Downgraded two levels due to very serious concerns about imprecision (very small sample size of the study and large confidence interval).
2 Downgraded two levels due to serious concerns about risk of bias (Zhao 2011 which carries 98.3% weight for this outcome, Random sequence generation, Allocation concealment and selective reporting were graded as unclear risk of bias) and imprecision (Difference in duration of mechanical ventilation was less than one day which is clinically insignificant).
3 Downgraded three levels due to serious concerns about risk of bias (Random sequence generation, Allocation concealment and Selective reporting were assessed as unclear risk of bias), indirectness (Clinically relevant adverse events were not reported) and imprecision (Small number of patients in the study Zhao 2011).