HEAT HumiGard Evaluation Study
Research type
Research Study
Full title
Quality of recovery and perioperative Hypothermia in Elective colectomy patients: A feasibility study of a blinded randomised controlled trial
IRAS ID
271720
Contact name
Jared Torkington
Contact email
Sponsor organisation
Cardiff and Vale University Local Health Board
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
During long surgical procedures under general anaesthetic, patients’ body temperatures sometimes drop below 36°C. This is classified as hypothermia. These low temperatures are associated with medical complications and surgical wound infections. Despite various warming methods used during surgery a significant number of patients experience hypothermia during surgery. During laparoscopic procedures, standard practice is to use dry, unwarmed CO2 to inflate the peritoneum (insufflation). This may contribute to the risk of hypothermia and cause tissue desiccation.
HumiGard is a CE marked device which humidifies and heats CO2 for insufflation. It is used together with other standard methods of keeping patients warm. Other studies suggest that the HumiGard device may prevent hypothermia, and help patients recover more quickly and with fewer problems after surgery.
We aim to find out whether the HumiGard device used with standard practice, gives better outcomes for patients, compared to standard care alone. To do this, we first need to work out if such a study would be feasible to do and therefore whether a larger study can be done.
A total of 40 patients who are having a laparoscopic colectomy operation (where a portion of their bowel is removed) will be recruited. Half will be treated with the HumiGard device plus standard care and half will be treated with a sham HumiGard device plus standard care. Patients will be allocated to one of these groups by random chance. Neither the patient, the surgeon, nor the assessor will know which treatment the patient is having.
We will measure patients’ temperature during surgery, and also patients will be asked to complete a validated questionnaire to measure their quality of recovery and pain following surgery. The feasibility study will aim to highlight the most appropriate outcomes to be measured in a larger RCT.REC name
Wales REC 3
REC reference
19/WA/0266
Date of REC Opinion
17 Sep 2019
REC opinion
Favourable Opinion