Berger 2017.
Methods | Design: parallel (2 arms) Country: Austria Multisite: no International: no Treatment duration: not stated Follow‐up: 48 hours Rate of ascent (m/h): unclear Final altitude reached: 3450 m AMS scale: Lake Louise Consensus Symptoms score (LLS) + AMS‐C Score |
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Participants |
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Interventions |
RIPC group (intervention): 4 cycles of lower limb ischaemia, induced by inflation of 2 thigh cuffs to 200 mmHg. Cuffs were left inflated for 5 minutes, followed by 5 minutes of deflation. Sham group (control): 4 cycles of sham ischaemia, induced by inflation of 2 thigh cuffs to 20 mmHg. Cuffs were left inflated for 5 minutes, followed by 5 minutes of deflation. Both protocols were performed al low altitude (750 m) and were completed approximately 30 minutes before ascent. |
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Outcomes |
Outcomes were not pre‐defined as primary or secondary
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Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information to score this item as low or high risk of bias Quote: "subjects were randomly assigned to undergo either RIPC or sham preconditioning (...)" Page 5 |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to score this item as low or high risk of bias |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "subjects were informed that the aim of the study was to explore differences between preconditioning by ischaemia of the arterial plus venous versus the venous vasculature alone. The investigator who performed the preconditioning procedure was excluded from the assessment of other study data" Page 6 |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to score this item as low or high risk of bias |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 2 patients (RIPC group) were excluded from analysis after 25 hours of follow‐up. However, these exclusions did not affect the estimation of AMS cases and severity (measured at 24 hours) |
Selective reporting (reporting bias) | High risk | Patient‐important outcomes, such as adverse events, were not reported |
Other bias | Low risk | No additional biases were identified |