VATS
Research type
Research Study
Full title
Vagal Augmentation with Transcutaneous Stimulation
IRAS ID
270759
Contact name
Gareth Ackland
Contact email
Sponsor organisation
R&D Governance Operations Manager, Joint Research Management Office, Queen Mary University of London
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Research Registry (registered 08/02/2021), researchregistry6550
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Summary of Research
There is loss of function in a nerve called the vagus nerve during major surgery. Loss of function in the vagus nerve is associated with increased risk of complications and death after surgery. The mechanisms resulting in loss of function in the vagus nerve require greater exploration, in order to develop strategies to improve outcomes following major surgery.
The vagus nerve protects the heart and other vital organs, by feeding back information to the brain, and subsequently mounting a protective response. Patient studies suggest that loss of function in the vagus nerve is also a feature of pain and anxiety. We aim to identify potential benefits of a device to control pain and maintain/boost function of the vagus nerve, in patients scheduled for major surgery involving bone/joint repair.
We will test function of the vagus nerve by activating a particular nerve reflex, which involves 30 minutes daily (i) stimulation of a battery-operated portable device attached to patients’ outer ears or (ii) no stimulation. Patients shall be randomly assigned to one of these two intervention groups.
The interventions will be performed on the day of surgery, and on the first 2 days after surgery. Pain scores (with a validated assessment tool), markers of function of the vagus nerve (through ECG-recorded heart rate changes and a sitting to standing test) and a blood test will be taken at these times; these outcome measures shall be compared between the two intervention groups. Patients will perform the sitting to standing test whilst recording an ECG, in which wires monitoring the heart will be attached on the chest. The study shall be completed in 12 months.Summary of Results
From June 22, 2021 to July 7, 2022, 79/86 patients (average age of 49 years; 45% female) completed their assigned interventions before and after surgery. For the main outcome of interest, the average reduction in visual analogue score (a pain score ranging from 0mm (no pain) to 100mm (the most severe pain)) was 19mm after stimulation (40 patients), versus 10mm after placebo (39 patients). This was a significant difference upon statistical testing. A clinically important reduction in pain after surgery was 5.5 times more likely in the stimulation group, occurring in 31/40 (78%) patients after stimulation, compared with 15/39 (38%) patients assigned to placebo. Only the stimulation group experienced reductions in pain in tandem with changes in nerve activity relating to the involuntary nervous system. Severe side-effects (skin irritation at the ear stimulation site ) occurred in six patients receiving stimulation, compared with two receiving placebo.
REC name
London - Central Research Ethics Committee
REC reference
21/LO/0272
Date of REC Opinion
6 May 2021
REC opinion
Further Information Favourable Opinion