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

Euan J McCaughey, Annemijn H Jonkman, Claire L Boswell-Ruys, Rachel A McBain, Elizabeth A Bye, Anna L Hudson, David W Collins, Leo M A Heunks, Angus J McLachlan, Simon C Gandevia, Jane E Butler, Euan J McCaughey, Annemijn H Jonkman, Claire L Boswell-Ruys, Rachel A McBain, Elizabeth A Bye, Anna L Hudson, David W Collins, Leo M A Heunks, Angus J McLachlan, Simon C Gandevia, Jane E Butler

Abstract

Background: For every day a person is dependent on mechanical ventilation, respiratory and cardiac complications increase, quality of life decreases and costs increase by > $USD 1500. Interventions that improve respiratory muscle function during mechanical ventilation can reduce ventilation duration. The aim of this pilot study was to assess the feasibility of employing an abdominal functional electrical stimulation (abdominal FES) training program with critically ill mechanically ventilated patients. We also investigated the effect of abdominal FES on respiratory muscle atrophy, mechanical ventilation duration and intensive care unit (ICU) length of stay.

Methods: Twenty critically ill mechanically ventilated participants were recruited over a 6-month period from one metropolitan teaching hospital. They were randomly assigned to receive active or sham (control) abdominal FES for 30 min, twice per day, 5 days per week, until ICU discharge. Feasibility was assessed through participant compliance to stimulation sessions. Abdominal and diaphragm muscle thickness were measured using ultrasound 3 times in the first week, and weekly thereafter by a blinded assessor. Respiratory function was recorded when the participant could first breathe independently and at ICU discharge, with ventilation duration and ICU length of stay also recorded at ICU discharge by a blinded assessor.

Results: Fourteen of 20 participants survived to ICU discharge (8, intervention; 6, control). One control was transferred before extubation, while one withdrew consent and one was withdrawn for staff safety after extubation. Median compliance to stimulation sessions was 92.1% (IQR 5.77%) in the intervention group, and 97.2% (IQR 7.40%) in the control group (p = 0.384). While this pilot study is not adequately powered to make an accurate statistical conclusion, there appeared to be no between-group thickness changes of the rectus abdominis (p = 0.099 at day 3), diaphragm (p = 0.652 at day 3) or combined lateral abdominal muscles (p = 0.074 at day 3). However, ICU length of stay (p = 0.011) and ventilation duration (p = 0.039) appeared to be shorter in the intervention compared to the control group.

Conclusions: Our compliance rates demonstrate the feasibility of using abdominal FES with critically ill mechanically ventilated patients. While abdominal FES did not lead to differences in abdominal muscle or diaphragm thickness, it may be an effective method to reduce ventilation duration and ICU length of stay in this patient group. A fully powered study into this effect is warranted.

Trial registration: The Australian New Zealand Clinical Trials Registry, ACTRN12617001180303. Registered 9 August 2017.

Keywords: Critical illness; Electrical stimulation; Mechanical ventilation; Respiratory function; Respiratory muscles.

Conflict of interest statement

AJM is employed by Liberate Medical LLC, a medical device company that is developing an abdominal muscle stimulator. EJM has previously received financial support from Liberate Medical LLC to conduct a systematic review [13].

Figures

Fig. 1
Fig. 1
Consort flow diagram of patients admitted to the intensive care unit (ICU) and the randomisation process
Fig. 2
Fig. 2
Cumulative incidence curves for mechanical ventilation duration (a) and intensive care unit (ICU) length of stay (b). Fourteen participants survived to ICU discharge (8 active (dark grey), 6 control (light grey)). One control participant was transferred to another hospital before extubation and as such was censored from both the ventilation duration and ICU length of stay analysis. After extubation, one control participant withdrew consent and one was withdrawn due to threatening behaviour, both were censored from the ICU length of stay analysis. Competing events were death or withdrawal of treatment (e.g., ventilator support) with the intention of subsequent death (marked with a dark grey asterisk). Participants who were censored are represented by a light grey asterisk. ICU intensive care unit

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