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Table 4 Primary and secondary outcomes for the intention to treat population

From: Point-of-care ultrasound of the heart and lungs in patients with respiratory failure: a pragmatic randomized controlled multicenter trial

  Intervention group (n = 106)
n (%; 95% CI)
Control group (n = 105)
n (%; 95% CI)
P value Absolute effect
% (95% CI)
Relative effect
(95% CI)
PRIMARY ENDPOINT
4 h after admission to the ED
  Proportion of patients with presumptive diagnoses in agreement with final diagnoses 84 (79.3%; 70.3–86.0) 81 (77.1%; 68.0–84.3) 0.71 2.1% (−9.0–13.2) 1.03(0.89–1.18)
SECONDARY ENDPOINTS
4 h after admission to the ED
  Proportion of patients with appropriate treatment ordered a 84 (79.3%; 70.3–86.0) 69 (65.7%; 56.0–74.3) 0.03 13.5% (1.6–25.5) 1.21 (1.02–1.43)
After primary assessment in the ED
  Proportion of patients with presumptive diagnoses in agreement with final diagnoses 65 (61.3%; 51.6–70.2) 65 (61.9%; 52.1–70.8) 0.93 −0.5% (−13.7–12.5) 0.99(0.80–1.23)
Specific treatment prescribed within 4 h from admission to the ED
  Oxygen 33 (31.1%; 22.5–40.0) 37 (35.2%; 26. 2–45.2) 0.53 −4.1% (−16.8–8.6) 0.88 (0.60–1.30)
  NIV/CPAP 3 (2.80%; 0.9–8.4) 0 (0%; 0–3.5¥) 0.08 2.8% (−0.3–6.0)
  Respirator 0 (0%; 0–3.4¥) 0 (0%; 0–3.5¥) 0
  Bronchodilators 26 (24.5%; 16.5–34.0) 20 (19.1%; 12.0–27.9) 0.34 5.5% (−5.6–16.6) 1.29 (0.77–2.16)
  Systemic steroids 24 (22.6%; 14.9–31.9) 21 (20.0%; 12.8–28.9) 0.64 2.6% (−8.4–13.7) 1.13 (0.67–1.90)
  Antibiotics 30 (28.3%; 19.9–38.2) 38 (36.2%; 27.0–46.1) 0.22 −7.9% (−20.5–4.7) 0.78 (0.53–1.16)
  Fluids i.v. 15 (14.2%; 7.7–22.0) 25 (23.8%; 16.0–33.1) 0.07 −9.7% (− 20.2–0.8) 0.59 (0.33–1.06)
  Diuretics 13 (12.3%; 7.0–20.8) 12 (11.4%; 6.0–19.1) 0.85 0.8% (−7.9–9.6) 1.07 (0.51–2.24)
  Antiarrythmics 4 (3.8%; 1.1–9.7) 3 (2.9%; 0.6–8.1) 0.71 0.9% (−3.9–5.7) 1.32 (0.30–5.76)
  Vasoconstrictors 0 (0%; 0–3.4¥) 0 (0%; 0–3.5¥) 0
  Anticoagulants 10 (9.4%; 4.8–17-3) 13 (12.4%; 6.8–20.2) 0.49 −2.9% (−11.4–5.5) 0.76 (0.35–1.66)
  Therapeutic centesis b 3 (2.8%; 0.6–8.4) 3 (2.9%; 0.6–8.1) 0.99 −0.0% (−4.5–4.5) 0.99 (0.20–4.80)
  Others 8 (7.6%; 3.4–14.9) 6 (5.7%; 2.1–12.0) 0.59 1.8 (−4.9–8.5) 1.32 (0.47–3.68)
Supplementary diagnostic tests ordered within 4 h from admission to the ED
  Ultrasound of the lungs c 34 (32.1%; 23.3–41.8) 10 (9.5%; 4.7–16.8) 0.0001 22.6% (12.0–33.1) 3.37 (1.76–6.46)
  X-ray of the thorax 85 (80.2%; 71.3—87.2) 90 (85.7%; 77.5–91.8) 0.29 −5.5% (−15.6–4.6) 0.94 (0.83–1.06)
  CT of the thorax 10 (9.4%; 4.6–16.7) 9 (8.6%; 4.0–15.6) 0.83 0.9% (−6.9–8.6) 1.10 (0.47–2.60)
  MR of the thorax 0 (0%; 0–3.4¥) 0 (0%; 0–3.5¥) 0
  Diagnostic centesisb 1 (0.9%; 0.0–5.1) 2 (1.9%; 2.3–6.7) 0.56 −1.0% (−4.2–2.2) 0.50 (0.05–5.58)
  Echocardiography by cardiologist 15 (14.2.%; 8.1–22.3) 19 (18.1%; 11.3–26.8) 0.44 −3.9% (−13.9–6.0) 0.78 (0.42–1.45)
  Ultrasound of the deep veins d 2 (1.90%; 0.2–6.6) 0 (0%; 0–3.5¥) 0.16 1.9% (−0.7–4.5)
  Other diagnostic tests 24 (22.6%; 15.1–31.8) 12 (11.4%; 6.0–19.1) 0.02 11.2% (1.2–21.2) 1.98 (1.05–3.75)
Time spent in the ED (hours)
   < 1 24 (22.6%; 15.6–31.7) 28 (26.7%; 19.0–36.1) 0.50 −4.0% (−15.6–7.6) 0.85 (0.53–1.36)
  1–2 20 (18.9%; 12.4–27.6) 24 (22.9%; 15.7–32.0) 0.48 −4.0% (−14.9–7.0) 0.83 (0.49–1.40)
  3–4 23 (21.7%; 14.8–30.7) 18 (17.1%; 11.0–25.7) 0.40 4.6% (−6.1–15.2) 1.3 (0.73–2.20)
  5–8 15 (14.2%; 8.6–22.3) 17 (16.2%; 10.2–24.7) 0.68 −2.0% (−11.7–7.6) 0.87 (0.46–1.66)
  9–24 10 (9.4%; 5.1–16.8) 5 (4.8%; 2.0–11.1) 0.19 4.7% (−2.2–11.6) 1.98 (0.70–5.60)
  25–48 8 (7.6%; 3.8–14.5) 5 (4.8%; 2.0–11.1) 0.40 2.8% (−3.7–9.3) 1.58 (0.54–4.69)
   > 48 6 (5.7%; 2.5–12-2) 9 (8.6%; 4.5–15.8) 0.60 −2.0% (−8.7–4.8) 0.74 (0.27–2.07)
Time spent in hospital (days)
   < 1 42 (39.6%; 25.8 38.4) 25 (23.8%; 16.5–33.0) 0.01 15.8% (3.4–28.2) 1.66 (1.10–2.52)
  1 14 (13.2%; 12.1–22.3) 21 (20.0%; 13.3–28.9) 0.18 −6.8% (−16.8–3.2) 0.66 (0.36–1.23)
  2 8 (7.6%; 5.0–12.6) 9 (8.6%; 4.5–15.8) 0.78 −1.0% (−8.4–6.3) 0.88 (0.35–2.19)
  3 11 (10.4%; 5.7–13.7) 8 (7.6%; 3.8–14.6) 0.48 2.8% (−5.0–10.5) 1.36 (0.57–3.25)
  4–7 16 (15.1%; 14.2–24.9) 24 (22.9%; 15.7–32.0) 0.15 −7.8% (−18.3–2.8) 0.66 (0.37–1.17)
   > 7 15 (14.2%; 11.3–21.2) 18 (17.4%; 11.0–25.7) 0.55 −3.0% (−12.8–6.8) 0.83 (0.44–1.55)
Itinerary: After discharge from the ED patients were:
  Transferred to the ICU 0 (0%; 0–3.4¥) 1 (1%; 0.1–6.6) 0.31 −1.0% (−0.3–0.0) 0
  Transferred to a hospital ward 52 (49.0%; 39.5–58.6) 52 (49.5%; 39.9–59.1) 0.95 −0.5% (−14.0–13.0) 0.99 (0.75–1.30)
  Sent home 54 (50.9%; 41.4–60.5) 52 (49.5%; 39.9–59.1) 0.84 −1.42% (− 12.1–14.9) 1.03 (0.79–1.35)
Readmission
  Patients readmitted ≤30 days from discharge 23 (21.7%; 14.8–30.7) 23 (21.9%; 14.9–31.0) 0.97 −0.26% (−11.3–10.9) 0.99 (0.59–1.65)
Mortality
  In hospital 2 (1.9%; 0.2–6.6) 4 (3.8%; 1.0–9.5) 0.40 −1.9% (−6.4–2.6) 0.49 (0.92–2.64)
  30 day mortality 2 (1.9%; 0.2–6.6) 7 (6.7%; 2.7–13.3) 0.09 −4.8% (− 10.2–0.6) 0.28 (0.06–1.33)
  1. Abbreviations: n number of patients, NIV Non-invasive ventilation, CPAP Continuous positive airway pressure, ED emergency department, ICU intensive care unit. One-sided 97.5% confidence interval
  2. aAccording to local treatment guidelines for the diseases in question
  3. bPleura-, thoraco-, cardio-centesis
  4. cPerformed by a radiologist or ultrasonographer certified in lung ultrasound
  5. dPerformed by radiologist or certified ultrasonographer