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Humigard evaluation study (HEAT)

Lay 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. During laparoscopic procedures, standard practice is to use dry, unwarmed carbon dioxide (CO2) to inflate the peritoneum (insufflation). This may contribute to the risk of hypothermia and cause tissue desiccation. HumiGard is a 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.

The investigators 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, the investigators first need to work out if such a study would be feasible to do and therefore whether a larger study can be done.

This study is now completed. 

Publications

The following is a protocol for a future full-sized RCT:

Ryczek, E., White, J., Poole, R. L., Reeves, N. L., Torkington, J., & Carolan-Rees, G. (2019). Normothermic insufflation to prevent perioperative hypothermia and improve quality of recovery in elective colectomy patients: protocol for a randomized controlled trial. JMIR research protocols8(12), e14533.

Cedar's role

Cedar carried out the following trial management roles:

  • Protocol design, approvals and study initiation
  • Randomisation and data management
  • Monitoring and safety reporting
  • Analysis and reporting

Study details:

  • Full title of clinical trial: Quality of Recovery and Perioperative Hypothermia in Elective Colectomy Patients: A Feasibility Study of a Blinded Randomised Controlled Trial
  • Study design: Feasibility RCT
  • Chief Investigator: Prof Jared Torkington
  • Sponsor: Cardiff and Vale University Health Board
  • Funding: Unrestricted educational grant from F&P Healthcare
  • NCT: NCT04164706
  • Ethical approval: 19/WA/0266