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Table 3 Screen failures prior to COVID-19 and during COVID-19 University of Minnesota

From: The impact of the COVID-19 pandemic on ICU clinical trials: a description of one research team’s experience

Reason for screen failure

Frequency prior to COVID

N = 1474

Frequency during COVID

N = 1620

p-value*

Hypotension outside eligibility parameters

194 (13%)

168 (10%)

0.02*

Paralysis/unable to use push-button device

38 (3%)

27 (2%)

0.10

Acute stroke/seizures

160 (11%)

79 (5%)

 < 0.0001*

Cognitive impairment

58 (4%)

7 (0.5%)

 < 0.0001*

Coma

2 (0.1%)

0 (0%)

 < 0.0001*

Dementia

39 (3%)

2 (0.1%)

0.23

RASS outside eligibility parameters

374 (25%)

256 (16%)

 < 0.0001*

Chronic ventilator support in residence

13 (1%)

19 (1%)

0.5

Language barrier

44 (3%)

76 (5%)

0.01*

Chemical paralysis

38 (3%)

18 (1%)

0.003*

No sedation in previous 24 h

23 (1.5%)

32 (2%)

0.41

Unable to follow simple commands

41 (3%)

178 (11%)

 < 0.0001*

Need for multiple sedative medications

10 (0.7%)

44 (3%)

 < 0.0001*

ECMO

87 (6%)

81 (5%)

0.34

Alcohol withdrawal protocol requiring specific sedative medications

21 (1.5%)

7 (0.5%)

0.004*

Temporary pacemaker/severe bradycardia

90 (6%)

67 (4%)

0.02*

Procedure(s) requiring heavy sedation

2 (0.1%)

16 (1%)

0.0015*

Documented research opt-out

47 (3%)

12 (0.7%)

 < 0.0001*

COVID-19 positive

–––

331 (20%)

––

  1. Note: Percentages do not sum to 100%; p < .05*
  2. Abbreviations: COVID-19 SARS-CoV-2, ECMO extracorporeal membrane oxygenation, RASS Richmond Agitation-Sedation Scale