Table 2. Components of the Primary Outcome and Secondary Outcomesa.
Outcome | No. (%) | Value (95% CI) | Absolute difference, percentage points (95% CI)b | |
---|---|---|---|---|
Restricted intubation (n = 116) | Control (n = 109) | |||
Components of the primary outcome | ||||
In-hospital death | 0 | 0 | NC | NC |
Intensive care unit admission | 46 (39.7) | 72 (66.1) | OR = 0.23 (0.12 to 0.44) | −29.2 (−41.0 to −17.4) |
Median length of intensive care unit stay (IQR), h | 0 (0 to 18.5) | 24.0 (0 to 57.0) | RR = 0.39 (0.24 to 0.66) | |
Median length of hospital stay (IQR), h | 21.5 (10.5 to 44.5) | 37.0 (16.0 to 79.0) | RR = 0.74 (0.53 to 1.03) | |
Mechanical ventilation | 21 (18.1) | 65 (59.6) | OR = 0.12 (0.06 to 0.24) | −42.5 (−54.1 to −30.9) |
Additional secondary outcomes | ||||
Median length of mechanical ventilation (IQR), h | 0 (0 to 0) | 6.0 (0 to 21.0) | RR = 0.21 (0.11 to 0.38) | |
Occurrence of pneumonia | 8 (6.9) | 16 (14.7) | OR = 0.43 (0.18 to 1.05) | −7.8 (−15.9 to 0.3) |
Adverse event from intubationc | 7/113 (6.0) [n = 113] | 16/107 (14.7) [n = 107] | OR = 0.37 (0.15 to 0.95) | −8.6 (−16.6 to −0.7) |
Systolic blood pressure <90 mm Hg | 3 (2.7) | 2 (1.9) | ||
Peripheral oxygen saturation <90% | 2 (1.8) | 4 (3.7) | ||
Vomiting | 2 (1.8) | 0 | ||
Difficult intubation with IDS ≥5 | 1 (0.9) | 14 (13.1) | ||
Dental trauma | 0 | 2 (1.9) | ||
Cardiac arrest | 0 | 0 | ||
Esophageal intubation | 0 | 4 (3.7) | ||
First pass failure | 1/113 (0.9) | 14/107 (13.1) | OR = 0.06 (0.01 to 0.46) | −12.2 (−18.8 to −5.6) |
Abbreviations: IDS, Intubation Difficulty Scale; NC, not calculated; OR, odds ratio; RR, rate ratio.
All outcomes were truncated at 28 days.
Differences were computed with a generalized mixed linear model with the center as random effect.
The sums of different numbers of adverse events may exceed the number of patients with adverse events because more than 1 adverse event can occur in a patient.