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Table 2 Adverse events stratified by group. Serious adverse events and non-serious adverse events are reported separately. All data are reported as absolute number of events, as well as the proportion of all serious adverse or non-serious adverse events per group. While some participants experienced multiple adverse events (see the “Results” section: “Adverse events”), none of the adverse events reported here were deemed to be related to the intervention

From: Abdominal functional electrical stimulation to assist ventilator weaning in critical illness: a double-blinded, randomised, sham-controlled pilot study

 

Active

Control

Serious adverse events

 Death

2 (100%)

4 (50%)

 Serious cardiac events

0

3 (37.5%)

 Respiratory failure requiring reintubation

0

1 (12.5%)

 Total

2

8

Non-serious adverse events, n (%)

 Hospital-acquired infection

4 (50%)

6 (42.9%)

 Tracheostomy

1 (12.5%)

1 (7.1%)

 Blocked intracranial pressure drain

1 (12.5%)

0

 Headache

1 (12.5%)

0

 Pneumonia

1 (12.5%)

0

 Diarrhoea

0

1 (7.1%)

 Gout

0

1 (7.1%)

 High respiratory rate

0

1 (7.1%)

 Laparotomy

0

1 (7.1%)

 Cardiac event

0

1 (7.1%)

 Poorly healing surgical wound

0

1 (7.1%)

 Violence to staff

0

1 (7.1%)

 Total

8

14