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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