Table 2. Intubation Characteristics and Outcomes of Patients in a Study of the Effect of Rocuronium vs Succinylcholine on Out-of-Hospital Endotracheal Intubation Success.
| No./Total No. (%) | Absolute Difference (95% CI), %a | P Valueb | ||
|---|---|---|---|---|
| Rocuronium Group | Succinylcholine Group | |||
| Primary Outcome (Successful First-Attempt Intubation) | ||||
| Per-protocol analysis | 455/610 (74.6) | 489/616 (79.4) | −4.8 (1-sided 97.5% CI, −9.0 to ∞)c | |
| Randomized group analysis | 456/613 (74.4) | 489/617 (79.2) | −4.8 (1-sided 97.5% CI, −9.1 to ∞)c | |
| Secondary Outcomes | ||||
| Prespecified analyses | ||||
| Cormack-Lehane graded | ||||
| I (best view) | 375/609 (61.6) | 346/616 (56.2) | 5.4 (−0.3 to 10.9) | .06 |
| II | 125/609 (20.5) | 173/616 (28.1) | −7.6 (−11.5 to −3.7) | <.001 |
| III | 81/609 (13.3) | 72/616 (11.7) | 1.6 (−2.9 to 6.2) | .49 |
| IV (worst view) | 28/609 (4.6) | 25/616 (4.0) | 0.6 (−1.5 to 2.6) | .60 |
| Intubation Difficulty Scale score, mean (SD)e | 4.2 (2.9) | 4.1 (2.4) | 0.1 (−0.2 to 0.4) | .52 |
| Intubation Difficulty Scale score >5 | 138/605 (22.8) | 130/614 (21.2) | 1.6 (−3.5 to 6.8) | .53 |
| Copenhagen score (reflecting intubation conditions)f | ||||
| Excellent | 327/580 (56.4) | 313/584 (53.6) | 2.8 (−0.5 to 6.4) | .09 |
| Good | 206/580 (35.5) | 222/584 (38.0) | −2.5 (−6.1 to 0.5) | .10 |
| Poor | 47/580 (8.1) | 49/584 (8.4) | −0.3 (−3.0 to 2.6) | .87 |
| Need for alternative intubation techniques | ||||
| Stylet | 55/610 (9.0) | 51/616 (8.3) | 0.7 (−1.9 to 2.0) | .97 |
| Gum elastic bougie | 114/610 (18.7) | 107/616 (17.4) | 1.3 (−1.2 to 3.8) | .31 |
| Intubating laryngeal mask airway | 10/610 (1.6) | 2/616 (0.3) | 1.3 (0.5 to 2.4) | .003 |
| Cricothyrotomy | 0/610 (0.0) | 1/616 (0.2) | −0.2 (−0.5 to 0.2) | |
| Early intubation-related complications | .04 | |||
| Patients with at least 1 complication | 111/610 (18.2) | 143/616 (23.2) | −5 (−9.8 to −0.03) | |
| Hypoxemia episodesg | 55/610 (9.0) | 61/616 (9.9) | −0.9 (−4.4 to 2.6) | |
| Severe arrhythmiah | 12/610 (2.0) | 26/616 (4.2) | −2.2 (−3.8 to −0.7) | |
| Cardiac arrest | 22/609 (3.6) | 13/615 (2.1) | 1.5 (−0.1 to 3.3) | |
| Pulmonary aspirationi | 19/610 (3.1) | 21/616 (3.4) | −0.3 (−1.7 to 1.1) | |
| Hypotension episodesj | 39/610 (6.4) | 62/615 (10.1) | −3.7 (−6.8 to −0.3) | |
| Exploratory analysesk | ||||
| No. of intubation attempts, mean (SD) | 1.4 (0.8) | 1.3 (0.6) | 0.1 (0.05 − 0.2) | <.001 |
| 2 | 110/609 (18.1) | 96/615 (15.6) | 2.5 (−2.2 to 6.9) | .31 |
| 3 | 34/609 (5.6) | 27/615 (4.4) | 1.2 (−0.8 to 3.2) | .23 |
| ≥4 | 10/609 (1.6) | 3/615 (0.5) | 1.1 (0.2 to 2.0) | .01 |
| Intubation failure under direct laryngoscopy | 11/610 (1.8) | 4/616 (0.7) | 1.1 (0.3 − 2.3) | .01 |
| Time of prehospital care, median (IQR), min | 55 (38 to 78) | 55 (39 to 80) | −2.2 (−6.9 to 2.5) | .35 |
| Death during prehospital care | 6/608 (1.0) | 3/615 (0.5) | 0.5 (−0.4 to 1.3) | .26 |
| Complications | ||||
| No. of complications per patient, median (IQR) | 0 | 0 | −0.09 (−0.17 to −0.08) | .03 |
| ≥1 severe complication | 115/608 (18.9) | 150/615 (24.4) | −5.5 (−10.8 to −0.05) | .04 |
| Unintentional extubation | 1/609 (0.2) | 4/615 (0.6) | 0.4 (−1.0 to 0.03) | .06 |
Abbreviation: IQR, interquartile range.
The estimated difference between the groups was calculated with a 2-sided 95% CI using a generalized estimated equation model, in which center was specified as the clustering factor.
Not corrected for multiple comparisons.
The estimated difference between the groups was calculated with a 1-sided 97.5% CI using a generalized estimated equation model, in which center was specified as the clustering factor. The margin for noninferiority was set at −7%. A lower bound of the CI that did not exceed this margin indicated noninferiority.
Reflects glottis visualization. Range, 1-4; higher scores indicate less glottis visualization.
Range, 0 (intubation without difficulty) to infinity; a value greater than 5 indicates difficult intubation.
The Copenhagen score is composed of 5 items with responses coded as “excellent,” “good,” or “poor”: laryngoscopy (easy, fair, difficult), vocal cords position (abducted, intermediate, closed), vocal cords movement (none, moving, closing), movements of the tube during insertion (none, slight, vigorous), and coughing during tracheal tube insertion (none, diaphragm, sustained); intubation conditions are defined as excellent if all items are excellent, good if all items are excellent or good, and poor if a single item is poor.
Defined as any oxygen saturation reading of less than 90%.
Ventricular tachycardia and ventricular fibrillation.
Visually detected by the physician during laryngoscopy.
Defined as a new episode of arterial systolic pressure of less than 90 mm Hg.
Post hoc outcomes.