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Table 1 Screen failures prior to COVID-19 and during COVID-19 both sites combined

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 = 2976

Frequency during COVID

N = 3912

p-value*

Hypotension outside eligibility parameters

361 (12%)

322 (8%)

 < 0.0001*

Paralysis/unable to use push-button device

73 (2.5%)

76 (2%)

0.18

Acute stroke/seizures

243 (8%)

132 (3%)

 < 0.0001*

Cognitive impairment

102 (3%)

27 (1%)

 < 0.0001*

Coma

23 (1%)

3 (0.1%)

 < 0.0001*

Dementia

75 (3%)

47 (1%)

 < 0.0001*

RASS outside eligibility parameters

776 (26%)

990 (25%)

0.64

Chronic ventilator support in residence

45 (2%)

47 (1%)

0.3

Language barrier

104 (3%)

184 (5%)

0.01*

Chemical paralysis

60 (2%)

41 (1%)

0.002*

No sedation in previous 24 h

150 (5%)

152 (4%)

0.02*

Unable to follow simple commands

180 (6%)

326 (8%)

0.0002*

Need for multiple sedative medications

43 (1.5%

57 (1.5%)

1.0

ECMO

89 (3%)

81 (2%)

0.02*

Alcohol withdrawal protocol requiring specific sedative medications

92 (3%)

52 (1%)

 < 0.0001*

Temporary pacemaker/severe bradycardia

90 (3%)

67 (2%)

0.004*

Procedure(s) requiring heavy sedation

58 (2%)

50 (1%)

0.03*

Documented research opt-out

47 (1.5%)

13 (0.3%)

 < 0.0001*

COVID-19 positive

–––

855 (22%)

––

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