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Table 2 Primary and secondary endpoints (VM vs HFNC)

From: The impact of high-flow nasal cannula oxygen therapy on exercise capacity in fibrotic interstitial lung disease: a proof-of-concept randomized controlled crossover trial

 

VM

HFNC

Difference (95% CI)

P-value**

Good responder*

15 (75%)

13 (65%)

  

Primary endpoint

 Endurance time, min

7.6 (5.0–10.1)

6.8 (4.3–9.3)

− 0.8 (− 4.4–2.8)

0.669

Secondary endpoint

 Min SpO2, %

89.4 (85.1–93.7)

89.7 (85.3–94.0)

0.3 (− 5.8–6.3)

0.934

 Max HR, bpm

124.2 (115.9–132.4)

120.8 (112.5–129.1)

−3.8 (− 11.7–4.2)

0.345

 Isotime Borg scale (dyspnea)

5.9 (4.6–7.1)

5.9 (4.7–7.1)

0.1 (− 1.7–1.8)

0.955

 Isotime Borg scale (leg fatigue)

5.7 (4.2–7.2)

5.4 (3.9–6.8)

− 0.3 (− 2.4–1.8)

0.757

 Final Borg scale (dyspnea)

7.0 (5.8–8.1)

6.6 (5.4–7.8)

− 0.4 (− 2.0–1.3)

0.672

 Final Borg scale (leg fatigue)

6.4 (4.9–7.9)

6.3 (4.8–7.8)

− 0.1 (− 2.3–2.1)

0.926

 Patient comfort of device

7.8 (6.7–8.9)

6.3 (5.2–7.4)

− 1.5 (− 3.1–0.1)

0.067

  1. Data are presented as number (%) or mean (95% CI)
  2. HFNC high-flow nasal cannula, HR heart rate, SpO2 saturation of peripheral oxygen, VM venturi mask
  3. *Good responder was defined as a patient with > 100 s or 33% improvement of endurance time from baseline CWRET,
  4. **Calculated by generalized linear mixed-effects model with fixed factors for each device, sequence, and period, and a random factor for subject within sequence