Methods
Study design
Definitions
Data acquisition
Complication
|
No. incidents (% of total number of incidents, n = 4,062)
|
---|---|
Aspiration | 54 (1.3%) |
Laryngospasm | 374 (9.2%) |
Hypoxemia | 226 (5.6%) |
Hypoventilation | 195 (4.8%) |
Hypertension | 76 (1.9%) |
Hypotension | 700 (17.2%) |
Myocardial ischemia / infarction | 114 (2.8%) |
Cardiac arrhythmia | 302 (7.4%) |
Acute cardiac decompensation | 26 (0.6%) |
Dental lesion | 36 (0.9%) |
Nerve / skin / cornea lesion | 141 (3.5%) |
Lesion through needle puncture | 127 (3.1%) |
Hypothermia | 79 (1.9%) |
Conversion of regional anesthesia / inadequate block | 416 (10.2%) |
Urinary retention | 19 (0.5%) |
Inadequate postoperative analgesia | 12 (0.3%) |
Postoperative agitation | 18 (1.7%) |
Awareness | 51 (1.3%) |
Allergic reaction | 111 (2.7%) |
Transfusion / mediation error | 106 (2.6%) |
Miscellaneous | 879 (21.6%) |
Statistical analysis
Results
Total number of anesthetics | Anesthetics with critical incidents | Critical incidents per 10,000 anesthetics (95% CI) |
P value | |
---|---|---|---|---|
110,310 | 3,807 | |||
Mean age
| 52 (95% CI, 33 to 69) | 55 (95% CI, 38 to 72) | <0.001 | |
Sex
| 0.001 | |||
Male | 53,741 (48.7%) | 1,903 (50.0%) | ||
Female | 56,569 (51.3%) | 1,904 (50.0%) | ||
ASA classification
| <0.001 | |||
I | 22,148 | 687 | 310 (288 to 334) | |
II | 31,948 | 1,387 | 434 (412 to 457) | |
III | 7,274 | 434 | 597 (545 to 654) | |
IV | 253 | 18 | 711 (454 to 1,096) | |
V | 1 | 0 | 0 (0 to 7,935) | |
Not specified | 48,686 | 1,281 | 263 (249 to 278) | |
Urgent surgery
| <0.001 | |||
Elective | 89,923 | 3,138 | 349 (337 to 361) | |
Emergency | 21,210 | 669 | 315 (292 to 339) |
Consequence of critical incident
| |||||||||
---|---|---|---|---|---|---|---|---|---|
Critical incident category | No consequence | Temporary consequence without intervention | Recovery after intervention | (Probable) permanent damage | Death | Death from another cause | None specified | Total (per 10,000 anesthetics; 99% CI) | Largest individual contribution of an anesthesiologist (%) |
Respiratory | 438 | 281 | 15 | 4 | 2 | 0 | 111 | 851 (77; 71 to 84) | 49 (5.8) |
Cardiovascular | 397 | 376 | 40 | 41 | 40 | 0 | 270 | 1,164 (106; 98 to 114) | 99 (8.5) |
Laboratory results | 6 | 2 | 0 | 0 | 0 | 0 | 3 | 11 (1; 0 to 2) | 4 (36.4) |
Central Nervous system | 45 | 41 | 0 | 0 | 0 | 0 | 26 | 112 (10; 8 to 13) | 11 (9.8) |
Equipment / Organization | 141 | 80 | 3 | 1 | 0 | 2 | 102 | 329 (30; 26 to 34) | 30 (9.1) |
Detriment/injury | 443 | 221 | 11 | 7 | 0 | 0 | 138 | 820 (74; 68 to 81) | 36 (4.3) |
Medication | 167 | 95 | 2 | 1 | 0 | 0 | 58 | 323 (29; 25 to 34) | 18 (5.6) |
Miscellaneous | 113 | 135 | 1 | 1 | 1 | 0 | 43 | 294 (27; 23 to 31) | 44 (15.0) |
Total (per 10,000 anesthetics; 99% CI) | 1,750 (159; 149 to 169) | 1,231 (112; 104 to 120) | 72 (7; 5 to 9) | 55 (5; 4 to 7) | 43 (4; 3 to 6) | 2 (0.2; 0 to 0.9) | 751 (68; 62 to 75) | 3,904 (354; 340 to 369) | 288 (7.4) |
Largest individual contribution of an anesthesiologist (%) | 88 (5.0) | 143 (11.6) | 8 (11.3) | 7 (13.7) | 4 (9.3) | 1 (50.0) | 111 (14.7) | 288 (7.4) | - |
Critical incident
| No consequence | Temporary consequence without intervention | Recovery after intervention | (Probable) permanent damage | Death | Death from another cause | None specified | Total (per 10,000 anesthetics) |
---|---|---|---|---|---|---|---|---|
Respiratory
|
438
|
281
|
15
|
4
|
2
|
0
|
111
|
851 (77)
|
Disconnection | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 7 (1) |
Kinking of tube | 3 | 2 | 0 | 0 | 0 | 0 | 1 | 6 (1) |
Accidental extubation | 18 | 5 | 0 | 0 | 0 | 0 | 2 | 25 (2) |
Unexpected difficult intubation | 133 | 38 | 1 | 0 | 0 | 0 | 44 | 216 (20) |
Impossible intubation | 13 | 7 | 4 | 0 | 1 | 0 | 3 | 28 (3) |
Failed intubation | 12 | 6 | 1 | 0 | 0 | 0 | 2 | 21 (2) |
Mainstem intubation | 2 | 3 | 0 | 0 | 0 | 0 | 1 | 6 (1) |
Re-intubation | 2 | 6 | 2 | 0 | 0 | 0 | 3 | 13 (1) |
Laryngospasm | 49 | 43 | 1 | 0 | 0 | 0 | 6 | 99 (9) |
Bronchospasm | 31 | 41 | 0 | 0 | 0 | 0 | 10 | 82 (7) |
Aspiration | 7 | 16 | 0 | 1 | 1 | 0 | 8 | 33 (3) |
Hypoventilation / hypoxemia | 58 | 65 | 1 | 1 | 0 | 0 | 12 | 137 (12) |
Difficult ventilation*
| 27 | 24 | 1 | 1 | 0 | 0 | 7 | 60 (5) |
Pulmonary edema | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 3 (0) |
Vomiting with laryngeal mask airway*
| 5 | 6 | 0 | 0 | 0 | 0 | 1 | 12 (1) |
Failure of laryngeal mask airway*
| 56 | 11 | 0 | 0 | 0 | 0 | 6 | 73 (7) |
Other respiratory disturbances | 16 | 8 | 3 | 1 | 0 | 0 | 4 | 32 (3) |
Cardiovascular
|
397
|
376
|
40
|
41
|
40
|
0
|
270
|
1,164 (106)
|
Hypotension | 168 | 121 | 9 | 3 | 0 | 0 | 131 | 432 (39) |
Hypertension | 18 | 12 | 2 | 1 | 0 | 0 | 15 | 48 (4) |
Arrhythmia | 52 | 51 | 2 | 0 | 3 | 0 | 35 | 143 (13) |
Tachycardia | 3 | 6 | 0 | 0 | 0 | 0 | 0 | 9 (1) |
Bradycardia | 25 | 11 | 0 | 0 | 0 | 0 | 1 | 37 (3) |
Hypovolemia | 24 | 68 | 17 | 12 | 17 | 0 | 25 | 163 (15) |
Heart failure | 2 | 13 | 2 | 4 | 4 | 0 | 2 | 27 (2) |
Pulmonary embolism | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 2 (0.2) |
Circulatory arrest | 40 | 36 | 2 | 12 | 5 | 0 | 14 | 109 (10) |
Myocardial infarction | 1 | 6 | 3 | 5 | 5 | 0 | 13 | 33 (3) |
Temporary ST-segmental changes*
| 27 | 41 | 3 | 1 | 0 | 0 | 25 | 97 (9) |
Hemodynamic instability due to sepsis*
| 3 | 3 | 0 | 2 | 4 | 0 | 5 | 17 (2) |
Vagal response to needle puncture*
| 33 | 8 | 0 | 0 | 0 | 0 | 4 | 45 (4) |
Other cardiovascular disturbances | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 (0.1) |
Laboratory results
|
6
|
2
|
0
|
0
|
0
|
0
|
3
|
11 (0.3)
|
Anemia | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0.1) |
Disturbances of electrolytes | 3 | 0 | 0 | 0 | 0 | 0 | 2 | 5 (0.5) |
Disturbances of serum glucose | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 3 (0.3) |
Other disturbances in laboratory results | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 2 (0.2) |
Central nervous system
|
45
|
41
|
0
|
0
|
0
|
0
|
26
|
112 (10)
|
Central anticholinergic syndrome | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 (0.1) |
Cerebral ischemia | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 2 (0.2) |
Seizure | 6 | 8 | 0 | 0 | 0 | 0 | 5 | 19 (2) |
Awareness*
| 2 | 2 | 0 | 0 | 0 | 0 | 3 | 7 (1) |
Postoperative agitation*
| 9 | 9 | 0 | 0 | 0 | 0 | 3 | 21 (2) |
Reaction of patient during anesthesia without awareness*
| 24 | 20 | 0 | 0 | 0 | 0 | 13 | 57 (5) |
Transurethral resection (TUR) syndrome*
| 2 | 1 | 0 | 0 | 0 | 0 | 1 | 4 (0.4) |
Other neurological disturbances | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0.1) |
Equipment / organization
|
141
|
80
|
3
|
1
|
0
|
2
|
102
|
329 (30)
|
Anesthetic machine | 18 | 6 | 0 | 0 | 0 | 0 | 2 | 26 (2) |
ECG-monitor | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0.1) |
Monitor of blood pressure | 4 | 2 | 0 | 1 | 0 | 1 | 9 | 17 (2) |
External pacemaker | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0.1) |
Pulse oximeter | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 (0.1) |
Intubation set | 2 | 1 | 0 | 0 | 0 | 0 | 1 | 4 (0.4) |
Drug application | 2 | 3 | 0 | 0 | 0 | 0 | 2 | 7 (1) |
Insufficient documentation*
| 14 | 4 | 0 | 0 | 0 | 0 | 16 | 34 (3) |
Inadequate preoperative screening*
| 15 | 5 | 0 | 0 | 0 | 0 | 15 | 35 (3) |
Inadequate preoperative preparation*
| 25 | 22 | 0 | 0 | 0 | 0 | 19 | 66 (6) |
Organizational problem*
| 38 | 30 | 3 | 0 | 0 | 1 | 29 | 101 (9) |
Failure of electronic anesthesia information management system*
| 8 | 2 | 0 | 0 | 0 | 0 | 1 | 11 (1) |
Electricity failure*
| 3 | 2 | 0 | 0 | 0 | 0 | 1 | 6 (1) |
Other kind of equipment | 10 | 3 | 0 | 0 | 0 | 0 | 6 | 19 (2) |
Detriment / injury
|
443
|
221
|
11
|
7
|
0
|
0
|
138
|
820 (74)
|
Technical difficulties with regional anesthesia | 295 | 73 | 2 | 0 | 0 | 0 | 75 | 445 (40) |
Total spinal*
| 31 | 10 | 0 | 0 | 0 | 0 | 2 | 43 (4) |
Spinal tap*
| 19 | 24 | 0 | 0 | 0 | 0 | 4 | 47 (4) |
Failed or repeated puncture (blood vessels) | 15 | 7 | 0 | 0 | 0 | 0 | 8 | 30 (3) |
Accidental puncture of artery*
| 24 | 13 | 2 | 0 | 0 | 0 | 7 | 46 (4) |
Teeth | 4 | 7 | 5 | 6 | 0 | 0 | 5 | 27 (2) |
Vessels | 4 | 3 | 0 | 0 | 0 | 0 | 2 | 9 (1) |
Muscles / soft tissue | 3 | 3 | 0 | 0 | 0 | 0 | 4 | 10 (1) |
Skin / lip | 17 | 25 | 0 | 0 | 0 | 0 | 5 | 47(4) |
Airway | 2 | 3 | 0 | 0 | 0 | 0 | 1 | 6 (1) |
Eyes | 0 | 3 | 0 | 1 | 0 | 0 | 2 | 6 (1) |
Epistaxis | 15 | 15 | 0 | 0 | 0 | 0 | 3 | 33 (3) |
Pneumothorax / hemothorax | 0 | 5 | 1 | 0 | 0 | 0 | 1 | 7 (1) |
Nerves | 0 | 8 | 0 | 0 | 0 | 0 | 4 | 12 (1) |
Failed urinary catheter*
| 6 | 11 | 0 | 0 | 0 | 0 | 8 | 25 (2) |
Accidental removal of intravenous catheter*
| 7 | 8 | 0 | 0 | 0 | 0 | 4 | 19 (2) |
Other detriment / injury | 1 | 2 | 1 | 0 | 0 | 0 | 3 | 7 (1) |
Medication
|
167
|
95
|
2
|
1
|
0
|
0
|
58
|
323 (29)
|
Inappropriate drug*
| 18 | 4 | 0 | 0 | 0 | 0 | 5 | 27 (2) |
Overdosage*
| 32 | 15 | 0 | 0 | 0 | 0 | 4 | 51 (5) |
Side effect*
| 4 | 5 | 0 | 0 | 0 | 0 | 6 | 15 (1) |
Wrong drug*
| 21 | 6 | 0 | 0 | 0 | 0 | 4 | 31 (3) |
Intravenous injection given subcutaneously*
| 34 | 37 | 1 | 1 | 0 | 0 | 14 | 87 (8) |
Inadequate administration of medication*
| 30 | 12 | 1 | 0 | 0 | 0 | 18 | 61 (6) |
Residual muscle paralysis after extubation*
| 19 | 11 | 0 | 0 | 0 | 0 | 3 | 33 (3) |
Accidental intravenous administration of local anesthetic*
| 4 | 1 | 0 | 0 | 0 | 0 | 0 | 5 (0.5) |
Other*
| 5 | 4 | 0 | 0 | 0 | 0 | 4 | 13 (1) |
Miscellaneous
|
113
|
135
|
1
|
1
|
1
|
0
|
43
|
294 (27)
|
Nausea / vomiting | 11 | 6 | 0 | 0 | 0 | 0 | 8 | 25 (2) |
Anaphylactic shock | 2 | 21 | 0 | 0 | 1 | 0 | 3 | 27 (2) |
Allergic reaction*
| 45 | 38 | 1 | 0 | 0 | 0 | 11 | 95 (9) |
Shivering | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0.1) |
Hypothermia | 28 | 47 | 0 | 0 | 0 | 0 | 4 | 79 (7) |
Transfusion reaction | 1 | 4 | 0 | 0 | 0 | 0 | 2 | 7 (1) |
Oliguria / acute renal failure | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 2 (0.2) |
Urinary retention*
| 4 | 6 | 0 | 0 | 0 | 0 | 6 | 16 (1) |
Insufficient postoperative pain management*
| 2 | 5 | 0 | 0 | 0 | 0 | 2 | 9 (1) |
Positioning*
| 11 | 4 | 0 | 0 | 0 | 0 | 0 | 15 (1) |
Failed gavage*
| 1 | 1 | 0 | 0 | 0 | 0 | 0 | 2 (0.2) |
Other | 6 | 3 | 0 | 1 | 0 | 0 | 6 | 16 (1) |
Total
|
1,750
|
1,231
|
72
|
55
|
43
|
2
|
751
|
3,904 (354)
|
Critical incident | Critical incident category | No of critical incidents (per 10,000 anesthetics; 99% CI) n = 3,904 |
---|---|---|
Technical difficulties with regional anesthesia | Detriment / injury | 445 (40; 36 to 6) |
Hypotension | Cardiovascular | 432 (39; 35 to 44) |
Unexpected difficult intubation | Respiratory | 216 (20; 16 to 23) |
Hypovolemia | Cardiovascular | 163 (15; 12 to 18) |
Arrhythmia | Cardiovascular | 143 (13; 11 to 16) |
Hypoventilation / hypoxemia | Respiratory | 137 (12; 10 to 16) |
Circulatory arrest | Cardiovascular | 109 (10; 8 to 13) |
Organizational problem | Equipment / Organization | 101 (9; 7 to 12) |
Laryngospasm | Respiratory | 99 (9; 7 to 12) |
Allergic reaction | Miscellaneous | 95 (9; 7 to 11) |
Critical incident | Permanent damage (per 10,000 anesthetics) | Death (per 10,000 anesthetics) |
---|---|---|
Respiratory
| 4 (0.4) | 2 (0.2) |
Impossible intubation | 0 | 1 (0.1) |
Aspiration | 1 (0.1) | 1 (0.1) |
Hypoventilation / hypoxemia | 1 (0.1) | 0 |
Difficult ventilation | 1 (0.1) | 0 |
Other respiratory disturbances | 1 (0.1) | 0 |
Cardiovascular
| 41 (3.7) | 40 (3.6) |
Hypotension | 3 (0.3) | 0 |
Hypertension | 1 (0.1) | 0 |
Arrhythmia | 0 | 3 (0.3) |
Hypovolemia | 12 (1.1) | 17 (1.5) |
Heart failure | 4 (0.4) | 4 (0.4) |
Pulmonary embolism | 1 (0.1) | 1 (0.1) |
Circulatory arrest | 12 (1.1) | 5 (0.5) |
Myocardial infarction | 5 (0.5) | 5 (0.5) |
Temporary ST-segmental changes | 1 (0.1) | 0 |
Hemodynamic instability due to sepsis | 2 (0.2) | 4 (0.4) |
Other cardiovascular disturbances | 0 | 1 (0.1) |
Equipment / organization
| 1 (0.1) | 0 |
Monitor of blood pressure | 1 (0.1) | 0 |
Detriment / injury
| 7 (0.6) | 0 |
Teeth | 6 (0.5) | 0 |
Eyes | 1 (0.1) | 0 |
Medication
| 1 (0.1) | 0 |
Intravenous injection given subcutaneously | 1 (0.1) | 0 |
Miscellaneous
| 1 (0.1) | 1 (0.1) |
Anaphylactic shock | 0 | 1 (0.1) |
Other | 1 (0.1) | 0 |
Total (per 10,000 anesthetics; 99% CI)
| 55 (5; 4 to 7) | 43 (4; 3 to 6) |