Table 2.
Cumulative Duration of Deviating Vital Sign Values Per 24 h
Intention-to-treat population | ||||
---|---|---|---|---|
Intervention (n = 200) |
Control (n = 200) |
Mean difference (95% CI) | P value | |
Primary outcome, combined cumulative | 60 [25–136] | 76 [28–192] | 20 (−20 to 60) | .19 |
Respiratory | ||||
Spo2 < 92%b | 216 [86–472] | 353 [142–627] | 90 (28–152) | .008 |
Spo2 < 88% | 37 [13–82] | 51 [16–148] | 47 (18–80) | .02 |
Spo2 < 85%a | 12 [3–31] | 14 [4–50] | 23 (2–44) | .23 |
Spo2 < 80% | 2 [0–5] | 2 [0–6] | 5 (−1 to 12) | .60 |
RF ≤ 5 min–1a | 0 [0–1] | 0 [0–1] | 1 (0–3) | .29 |
RF < 11 min–1 | 34 [7–102] | 36 [8–106] | 4 (−20 to 27) | .84 |
RF ≥ 24 min–1a | 14 [2–47] | 15 [2–69] | 2 (−25 to 29) | .60 |
HR < 30 min–1 | 0 [0–0] | 0 [0–0] | 1 (0–2) | .45 |
Circulatory | ||||
HR < 30 min–1 | 0 [0–0] | 0 [0–0] | 1 (0–2) | .45 |
HR < 40 min–1a | 0 [0–0] | 0 [0–0] | 3 (−1 to 7) | .36 |
HR > 110 min–1a | 7 [0–40] | 6 [0–38] | –5 (−30 to 18) | .71 |
HR > 130 min–1 | 0 [0–2] | 0 [0–2] | –3 (−11 to 4) | .34 |
SBP <70 mm Hg | 0 [0–0] | 0 [0–0] | 4 (−1 to 9) | .52 |
SBP <90 mm Hga | 22 [0–83] | 18 [0–106] | 18 (−15 to 50) | .74 |
SBP ≥180 mm Hg | 32 [0–75] | 33 [0–85] | 17 (−6 to 39) | 1.0 |
SBP ≥220 mm Hga | 0 [0–0] | 0 [0–0] | 0 (−6 to 5) | .41 |
Combination—SBP <100 mm Hg AND | ||||
HR > 110 min–1a | 0 [0–0] | 0 [0–0] | 2 (−1 to 4) | .30 |
HR < 50 min–1a | 0 [0–0] | 0 [0–0] | 3 (−1 to 8) | .15 |
Spo2 < 92%a | 0 [0–4] | 0 [0–7] | 5 (−5 to 14) | .29 |
The table presents the primary outcome in the first row, which is the cumulative duration of deviations outside the combined thresholds: Spo2 < 85% or 5 > RF > 24 min–1, or 40 > HR > 110 min–1, 91 > SBP >219 mm Hg, or a combination of SBP <100 mm Hg AND (HR > 110 or HR < 50 or Spo2 < 92%). All values are presented as median [interquartile range] or mean difference with (95% CI). All values are calculated as the number of deviating minutes per 24 h of monitoring.
Abbreviations: CI, confidence interval; COPD, chronic obstructive pulmonary disease; HR, heart rate; RF, respiration frequency; SBP, systolic blood pressure; Spo2, peripheral oxygen saturation.
All rows are categories that are part of the primary outcome, which is considered secondary outcomes.
Patients with BMI ≥40 or registered COPD are excluded from this analysis.