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Table 2 Primary and secondary endpoints

From: Respiratory support with nasal high flow without supplemental oxygen in patients undergoing endoscopic retrograde cholangiopancreatography under moderate sedation: a prospective, randomized, single-center clinical trial

 

The NHF group

N = 37

The LFO group

N = 38

Association measure

Estimate (95% CI)

p value

Incident of marked hypercapnia (the proportion of patients experiencing a PtCO2 ≥ 60 mmHg)

2.7% (1/37)

18.4% (7/38)

Risk ratioa

0.15 (0.02 to 1.13)

0.066

   

Risk difference (%)b

-15.7 (-29.1 to -2.4)

0.021

Time-weighted average for PtcCO2 (mmHg/min)c

47.2 ± 4.6

48.2 ± 5.7

Mean difference

-0.97 (-3.35 to 1.41)

0.421

Duration of hypercapnia (min)d

(PtCO2 ≥ 50 mmHg)

7 (0 to 99)

14.5 (0 to 206)

  

0.313

Incident of hypoxia (SpO2 ≦ 90%)

(the proportion of patients experiencing an SpO2 ≦ 90%)

8.1% (3/37)

5.3% (2/38)

Risk ratioe

1.54 (0.27 to 8.70)

0.62

Risk difference (%)f

2.8 (-8.5 to 14.2)

0.62

Hypercapnia (PtCO2 ≥ 50 mmHg)

56.8% (21 /37)

63.2% (24/38)

Risk ratioa

0.91 (0.63 to 1.31)

0.605

   

Risk difference (%)b

-7.5 (-29.0 to 14.0)

0.495

Ramsay score at start of procedureg

5 (4 to 6)

5 (4 to 6)

  

0.488

Initial dose of pethidine hydrochloride (mg)

35 (0 to 35)

35 (0 to 35)

Relative Riskh

0.99 (0.91 to 1.07)

0.761

Initial dose of midazolam (mg)

3 (2 to 5)

3 (2 to 6)

Relative Riskh

0.99 (0.77 to 1.26)

0.904

Total dose of pethidine hydrochloride (mg)

35 (0 to 105)

70 (0 to 175)

Rate ratioi

0.96 (0.91 to 1.02)

0.177

Total dose of midazolam (mg)

6.0 (2 to 20)

7.5 (3 to 35)

Rate ratioi

1.00 (0.85 to 1.17)

0.967

  1. Values are n (%), mean ± SD or median (minimum to maximum). LFO Low-flow oxygen via a nasal cannula, PtcCO 2 Transcutaneous CO2 partial pressure, SpO 2 Transcutaneous oxygen saturation
  2. aModified Poisson regression with body weight as an adjusted variable
  3. bDifference in risk per 100 population. Generalized linear model with body weight as an adjusted variable
  4. cAnalysis duration: 0 to 120 min Welch’s t-test
  5. dFisher exact test
  6. eModified Poisson regression
  7. f Generalized linear model
  8. gWilcoxon’s rank-sum test
  9. hPoisson regression with body weight as an adjusted variable
  10. iPoisson regression, log (time) as offset term, with body weight as an adjusted variable