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. 2021 Mar 11;147(5):1–10. doi: 10.1001/jamaoto.2021.0025

Table. Characteristics of Individual Trials, Patient Populations, and Interventions (Early vs Late Tracheotomy).

Source Criteria Patient characteristics, early vs late tracheotomy groupsa Severity scoring system, early vs late tracheotomy groupsa Center (No. in early/late tracheotomy group)
Inclusion Exclusion
Blot et al,25 2008 Age >18 y; expected intubation >7 d Previous tracheotomy or enrollment in the trial; major risk of bleeding; infection or anatomical deformity of the neck; severe respiratory insufficiency or neurological failure; high severity of illness scores

  • Age: 54.3 (14.9) vs 56.0 (14.6) y

  • Reason for admission: respiratory failure (34% vs 32%); neurology (21% vs 24%); trauma (18% vs 19%)

 SAPS II: 50 (17-103) vs 50 (15-96)b Multiple centers (61/62)
Bösel et al,26 2013 Age ≥18 y; admission to neuro-ICU; nontraumatic ICH/SAH/acute ischemic stroke; expected intubation ≥2 wk Ventilation >3 d; severe chronic cardiopulmonary comorbidities; anatomical or clinical conditions jeopardizing PDT; expected to require a permanent ST; enrolled in other trials; life expectancy <3 wk; pregnant

  • Age: 61 (12) vs 61 (13) y

  • Reason for admission: ICH (43% vs 43%); acute ischemic stroke (37% vs 30%); SAH (20% vs 27%)

  • SET: 13 (10-14) vs 13 (11-16)c

  • GCS: 9 (7-11) vs 8 (5-10)d

  • NIHSS: 21 (15-23) vs 20 (11-33)e

  • APACHE II: 17 (13-19) vs 16 (11-19)f

  • APS: 12 (10-14) vs 12 (8-15)g

  • mRS: 4 (4-5) vs 4 (3-4)h

 Single center (30/30)
Bouderka et al,3 2004 Isolated head injury with GCS ≤8 on admission; cerebral contusion on CT scan; GCS <8 on fifth day without any sedation Not reported Age: 41.1 (17.5) vs 40 (19) y SAPS: 5.4 (1.5) vs 6 (3.8)b Single center (31/31)
Bylappa et al,27 2011 Prolonged intubation due to noncorrosive poisoning, snakebites, head injuries, and respiratory paralysis due to neurological disease Trauma to the neck; previous neck surgery; tracheostomy; scar/keloid/previous radiotherapy in the neck; chemotherapy; fungating growth in neck; granulomatous disease; infection to neck

  • Age: 33.1 (16.4) vs 32.9 (12.7) y

  • Reason for admission: organophosphorus poisoning (59.1% vs 68.2%); MVC (13.6% vs 18.2%); cerebral malaria (18.2% vs 4.5%)

 Not reported Single center (22/22)
Diaz-Prieto et al,14 2014 Age >18 y; intubated >48 h Prior tracheotomy; included in another trial; technical difficulty in performing PDT

  • Age: 58.8 (12.7) vs 59.5 (12.3) y

  • Reason for admission: respiratory failure (68% vs 72%); coma (24% vs 19%)

  • SAPS II: 38 (3-78) vs 37.5 (10-85)b

  • SAPS III: 62 (32-114) vs 61 (29-105)b

  • APACHE II: 20 (5-40) vs 19 (4-38)f

  • ISS: 29 (9-66) vs 30 (25-59)i

  • SOFA: 6 (1-17) vs 6 (0-15)j

 Single center (245/244)
Dunham et al,21 2014 Age 18-65 y; blunt trauma with admission GCS≤8; ICH on brain CT scan Cardiac arrest, near-brain death, preexisting coagulopathy, or severe obesity

  • Age: 33 (13) vs 37 (16) y

  • Reason for admission: increased ICP (40.0% vs 55.6%); craniotomy (46.7% vs 44.4%)

  • ISS: 28 (11) vs 35 (9)i

  • GCS: 4 (2.5) vs 4 (0.9)d

  • Head Abbreviated Injury Score: 4.7 (0.6) vs 4.9 (0.3)k

 Single center (17/14)
Filaire et al,23 2015 Age 18-79 y; preoperative diagnosis of lung cancer or high suspicion of lung cancer; predicted postoperative DLco ≥30%; 30% ≤ ppoFEV1 < 50%; ppoVo2max ≥10 mL/kg/min; surgical approach by lateral or posterolateral thoracotomy Pregnant; preoperative tracheotomy; vocal cord paralysis; phrenic nerve paralysis on the operated side; neuromuscular disorders; previous pharyngeal or laryngeal surgery; anatomical deformity of the neck; video-assisted thoracoscopic surgery; lung resection less important than planned at the inclusion (ppoFEV1 ≥50%).

  • Age: 63.5 (8.2) vs 59.9 (7.8) y

  • Reason for admission: pneumonia (47.4% vs 64.3%); sepsis (47.4% vs 69.0%)

  • DLco: 60.0% (15.8%) vs 63.6% (16.7%)

  • Vo2max: 19.2 (3.4) vs 19.7 (3.6)

  • ppoFEV1: 41.3% (4.7%) vs 41.7% (6.7%)

 Single center (39/39)
Karlović et al,24 2018 Age >18 y; patients in surgical and trauma units; intubated >48 h; expected duration of mechanical ventilation ≥14 d based on diagnosis; SOFA score >5, APACHE II scores >10, Pao2 ≤60 mm Hg with FIO2 0.5 and PEEP of at least 8 cm H2O Previous tracheotomy; anatomical deformity of the neck; hematologic malignant neoplasms; respiratory infection within the first 48 h of mechanical ventilation

  • Age: 60.0 (13) vs 61.5 (28) y

  • Reason for admission: pneumonia (47.4% vs 64.3%)

  • APACHE II: 23.6 (8.1) vs 22.4 (7.3)f

  • SOFA: 14.0 (2.7) vs 14.8 (3.2)j

 Single center (38/42)
Koch et al,28 2012 Age >18 y; expected time of ventilation >21 d (decided by 2 independent intensivists not involved in the study) Anatomical variants or deformities of the larynx/trachea; preexisting tracheostomy; preexisting pneumonia; critical trauma of the cervical vertebral column; coagulopathy (thrombocyte level <60 × 103/μL; prothrombin time >40 s; INR>1.4); estimated to die within the next 24 h; planned permanent tracheostomy; >3 d of ventilation before entry into the study

  • Age: 61.7 (9.1) vs 57.3 (6.3) y

  • Reason for admission: trauma (19% vs 6%); neurosurgical (10% vs 18%); GI tract (8% vs 6%); sepsis (4% vs 7%); data only provided for 50 patients receiving intervention

 APACHE II: 21 (IQR 12-31) vs 22.3 (IQR 10-33)f Single center (50/50)
Rodriguez et al,20 1990 Patients with multiple injuries requiring mechanical ventilation Patients who did not require ventilator therapy >1 d; patients being actively disengaged from the ventilator; patients who died in the first 24 h

  • Age: 36 (2) vs 39 (2) y

  • Reason for admission: cranial neurological injury (63% vs 53%); chest injury (39% vs 40%); abdominal injury (22% vs 22%); extremity injury (43% vs 40%); fracture injury (57% vs 69%)

  • ISS: 28 (2) vs 27 (1)i

  • GCS: 10 (1) vs 7.1 (2.7)d

  • APACHE II: 10 (1) vs 10 (1)f

 Single center (51/55)
Rumbak et al,4 2004 Age >18 y; projected to need ventilation >14 d; APACHE II score >25 Anatomical deformity of the neck; previous tracheotomy; platelet count <50 × 103/μL, activated partial thromboplastin time/prothrombin time >1.5 times, or bleeding time >2 × normal; soft tissue infection of the neck; mechanical ventilation with a PEEP >12 cm H2O; intubated >48 h; neck on which it was technically difficult to perform a PDT

  • Age: 63 (10.4) vs 63 (9.3) y

  • Reason for admission: severe sepsis (70% vs 66%); renal failure (45% vs 41%); multiorgan failure (58% vs 55%)

 APACHE II: 27.4 (4.2) vs 26.3 (2.6)f Multiple centers (60/60)
Saffle et al,29 2002 Age >18 y; hospitalized within 24 h of acute burn injury; ongoing mechanical ventilatory support on postburn day 2 Pregnant women; preexisting significant renal or hepatic disease; corticosteroid use before admission; patients who did not have cutaneous burn injuries

  • Age: 44.5 (4.3) vs 51.3 (4.0) y

  • Reason for admission: full-thickness burn (34.0% vs 21.7%); inhalation injury (86.0% vs 87.0%)

 Not reported Single center (21/ 23)
Sugerman et al,19 1997 Intubated and required mechanical ventilation for 3 d; anticipated need for ventilatory support for ≥7 d Age <18 y; patients with major burns or inhalation injury

  • Age: 40 (2.4) y in head trauma cohort; 61 (3.4) y in non–head trauma cohort; 62 (4.6) y in nontrauma cohort. Details not provided for early vs late cohorts.

  • Reason for admission: head trauma (n = 67), non-head trauma (n = 41), non-trauma (n = 18)

 APACHE III: 66 (3) vs 55 (3)l Multiple centers (53/59)
Terragni et al,22 2010 Age >18 y; intubated for 24 h; SAPS II score 35-65; SOFA score ≥5; did not have a pulmonary infection (CPIS<6) COPD; anatomical deformity of the neck; cervical tumors; history of esophageal, tracheal or pulmonary cancer; previous tracheotomy; soft tissue infection of the neck; hematologic malignancy; pregnant

  • Age: 61.8 (17.4) vs 61.3 (16.8) y

  • Reason for admission: respiratory failure (45.9% vs 47.1%); CNS (22.9% vs 25.7%); cardiovascular (24.4% vs 20.0%)

  • SAPS II: 51.1 (8.7) vs 49.7 (8.6)b

  • SOFA at enrollment: 7.9 (2.6) vs 7.6 (2.9)j

  • SOFA at randomization: 10.1 (1.3) vs 9.8 (1.5)j

 Multiple centers (209/210)
Trouillet et al,30 2011 Undergone cardiac surgery; still mechanical ventilation 4 d after surgery; unsuccessful mechanical ventilation screening test result or spontaneous breathing trial on the day of randomization; expected to require mechanical ventilation for ≥7 more d Age <18 y; pregnant; previously enrolled in this or other trials of morbidity or mortality; received >48 h of mechanical ventilation preoperatively; previous tracheostomy within 6 mo; received an artificial heart device; prothrombin time >1.5 × upper limit of normal; platelet count <50 × 103/μL; irreversible neurological disorder; SAPS>80; decided to limit care; soft-tissue neck infections or anatomical deformities or concomitant neck or carotid surgery

  • Age: 64.1 (13.3) vs 66.0 (12.4) y

  • Reason for admission: CABG (25% vs 25%); valve (28% vs 32%); CABG plus valve (13% vs 19%)

  • SAPS II: 47.2 (12.4) vs 45.8 (11.4)b

  • SOFA: 11.6 (3.5) vs 10.9 (3.6)j

  • GCS: 10.9 (3.3) vs 11.4 (3.0)d

  • Lung injury score: 1.7 (0.7) vs 1.8 (0.7)m

  • Charlson Comorbidity Index: 2.9 (1.9) vs 2.6 (1.8)n

 Single center (109/107)
Young et al,31 2013 Mechanical ventilation in adult critical care units; identified by the treating clinician in the first 4 d after admission; likely to require ≥7 d of ventilatory support Requiring an immediate, life-saving tracheotomy; tracheotomy contraindicated for anatomical or other reasons; respiratory failure due to chronic neurological disease

  • Age: 63.6 (13.7) vs 64.2 (13.3) y

  • Reason for admission: respiratory (59.9% vs 59.0%); GI tract (19.1% vs 19.4%); cardiovascular (10.6% vs 13.2%); neurological (5.8% vs 4.4%). Primary reason for admission not recorded for 3.7% of patients

 APACHE II: 19.6 (6.5) vs 20.1 (6.0)f Multiple centers (451/448)
Zheng et al,32 2012 Age >18 y; treated with mechanical ventilation via endotracheal intubation Anatomical neck deformity; thyromegaly; cervical tumors; hematologic malignant neoplasm; previous tracheotomy; pregnant; weaned or died 48 h after mechanical ventilation onset

  • Age: 67.5 (14.7) vs 67.9 (17.6) y

  • Reason for admission: chronic lung disease (24.1% vs 23.0%); cardiac disease (24.1% vs 31.1%); neurological (29.3% vs 24.6%); chronic kidney disease (17.2% vs 18.0%)

  • APACHE II: 19.6 (2.3) vs 19.6 (2.5)f

  • SOFA: 7.4 (1.5) vs 7.3 (1.7)j

 Single center (58/61)

Abbreviations: APACHE II, Acute Physiology and Chronic Health Evaluation II; APS, Acute Physiology Score; CABG, coronary artery bypass graft; CNS, central nervous system; COPD, chronic obstructive pulmonary disease; CPIS, clinical pulmonary infection score; CT, computed tomography; DLco, diffusing capacity for carbon monoxide by single breath; FEV1, forced expiratory volume in 1 second; FIO2, fraction of inspired oxygen; GCS, Glasgow Coma Score; GI, gastrointestinal; ICH, intracranial hemorrhage; ICP, intracranial pressure; ICU, intensive care unit; INR, international normalized ratio; IQR, interquartile range; ISS, Injury Severity Score; mRS, modified Rankin Scale score; MVC, motor vehicle collision; NIHSS, National Institute of Health Stroke Scale; PDT, percutaneous dilational tracheotomy; PEEP, positive end expiratory pressure; ppo, predicted postoperative; SAH, subarachnoid hemorrhage; SAPS, Simplified Acute Physiology Score; SET, Stroke-related Early Tracheotomy score; SOFA, sequential organ function assessment; ST, surgical tracheotomy; Vo2max, maximal oxygen consumption.

SI conversion factor: To convert platelet and thrombocyte counts to ×109/L, multiply by 1.0.

a

Unless otherwise indicated, age and severity scoring system data are expressed as mean (SD) or median (interquartile range).

b

Scores range from 0 to 163, with higher scores indicating higher risk for mortality in patients in the intensive care unit (ICU).

c

Scores range from 8 to 48, with higher scores indicating tracheotomy need in patients with stroke.

d

Scores range from 3 to 15, with higher scores indicating neurologically intact after trauma injury.

e

Scores range from 0 to 42, with higher scores indicating severe stroke.

f

Scores range from 0 to 71, with higher scores indicating in-hospital mortality.

g

Equivalent to SAPS.

h

Scores range from 0 to 6, with higher scores indicating increased disability in people with neurological injury.

i

Scores range from 0 to 75, with higher scores indicating severe traumatic injury.

j

Scores range from 0 to 24, with higher scores indicating mortality in the ICU.

k

Scores range from 0 to 6, with higher scores indicating greater injury severity.

l

Scores range from 0 to 299, with higher scores indicating in-hospital mortality.

m

Scores range from 0 to 4, with higher scores indicating greater severity.

n

Scores range from 0 to 5 or greater, with higher scores indicating greater cumulative mortality attributable to comorbid disease.