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. 2020 Sep 1;324(9):1–11. doi: 10.1001/jama.2020.12866

Table 3. Primary and Secondary Outcomes.

Outcomes No. of events/total (%) Absolute difference (95% CI) P valuea
Low tidal volume (n = 614) Conventional tidal volume (n = 592)
Primary outcome
Composite respiratory complications within 7 d 231/608 (38.0) 232/590 (39.3) −1.3 (−6.8 to 4.2)b .64
Components of the primary outcome
Atelectasisc 150/608 (24.7) 147/591 (24.9) −0.2 (−5.1 to 4.7)b .93
Respiratory failured 103/612 (16.8) 109/590 (18.5) −1.6 (−6.0 to 2.7)b .45
Pleural effusion 67/611 (11.0) 69/590 (11.7) −0.7 (−4.3 to 2.9)b .69
Pneumonia 19/610 (3.1) 22/591 (3.7) −0.6 (−2.7 to 1.5)b .56
Unplanned noninvasive or invasive ventilation 15/612 (2.5) 14/591 (2.4) 0.1 (−1.7 to 1.9)b .92
Pulmonary congestion 10/612 (1.6) 14/591 (2.4) −0.7 (−2.4 to 0.9)b .36
Bronchospasm 5/612 (0.8) 5/590 (0.8) −0.0 (−1.1 to 1.1)b .95
Pneumothorax 2/611 (0.3) 0/591 (0.0) 0.3 (−0.1 to 0.8)b .26
Secondary outcomes
Composite respiratory complications during hospital stay 237/598 (39.6) 239/579 (41.3) −1.6 (−7.2 to 4.0)b .56
Pulmonary embolism 5/595 (0.8) 6/573 (1.0) −0.2 (−1.4 to 1.0)b .71
Acute respiratory distress syndrome 3/594 (0.5) 0/574 (0.0) 0.5 (−0.1 to 1.1)b
Systemic inflammatory response syndrome 6/612 (1.0) 13/591 (2.2) −1.2 (−2.8 to 0.2)b .09
Sepsis 20/612 (3.3) 13/591 (2.2) 1.1 (−0.8 to 3.0)b .26
Acute kidney injurye 36/420 (8.6) 42/394 (10.7) −2.1 (−6.2 to 2.0)b .31
Risk 24/36 (66.7) 32/42 (76.2)
Injury 8/36 (22.2) 4/42 (9.5)
Failure 4/36 (11.1) 6/42 (14.3)
Wound infection 11/597 (1.8) 10/575 (1.7) 0.1 (−1.5 to 1.7)b .89
Intraoperative need of vasopressor 518/600 (86.3) 511/584 (87.5) −1.2 (−5.0 to 2.7)b .55
Unplanned ICU admission 30/595 (5.0) 25/577 (4.3) 0.7 (−1.7 to 3.2)b .56
Need for rapid response team call 67/612 (10.9) 63/591 (10.7) 0.3 (−3.2 to 3.8)f .87
Length of stay, d
ICU, mean (SD) 0.5 (1.3) 0.6 (3.5) −0.1 (−0.4 to 0.2)f .84
Hospital, mean (SD) 8.3 (8.6) 7.9 (10.6) 0.4 (−0.6 to 1.6)f .40
In-hospital mortality, No. (%) 8 (1.3) 7 (1.2) 0.1 (−1.2 to 1.4)f .85

Abbreviation: ICU, intensive care unit.

a

Calculated using the χ2 test for categorical variables or from a generalized linear model considering an inverse Gaussian distribution for the continuous variables.

b

Risk difference from a generalized linear model considering a binomial distribution with an identity link.

c

Defined as lung opacification with a shift of the mediastinum, hilum, or hemidiaphragm toward the affected area and compensatory overinflation in the adjacent nonatelectatic lung.

d

Defined as postoperative partial pressure of oxygen <60 mm Hg on room air, a partial pressure of oxygen/fraction of inspired oxygen ratio <300 mm Hg, or arterial oxygen saturation measured by pulse oximetry <90% and requiring oxygen therapy.

e

Classified in 3 categories according to stage of kidney injury. Risk is defined as an increase in creatinine 1.5 times baseline level; injury, an increase in creatinine 2 times baseline level; and failure, an increase in creatinine 3 times baseline level or an increase in creatinine of ≥0.5 mg/dL if baseline creatinine was ≥4 mg/dL.

f

Mean difference from a generalized linear model considering a Gaussian distribution.