NCT04164706: HEAT

HEAT HumiGard Evaluation Study

Completed NA Last updated 11 March 2021

What this trial tests

NA trial testing HumiGard device in Laparoscopic Colorectal Surgery in 41 participants. Completed in 21 January 2021.

Timeline

14 November 2019

Primary endpoint
10 November 2020

21 January 2021

Quick facts

Lead sponsor	Cardiff and Vale University Health Board
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	41
Start date	14 November 2019
Primary completion	10 November 2020
Estimated completion	21 January 2021
Sites	1 location across United Kingdom

Drugs / interventions tested

• HumiGard device
• Standard care (with sham HumiGard device)

Conditions studied

• Laparoscopic Colorectal Surgery — all drugs for Laparoscopic Colorectal Surgery →

Sponsor

Cardiff and Vale University Health Board

Who can join

18 and older, any sex, with Laparoscopic Colorectal Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 carbon dioxide (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.

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.

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.

The investigators 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.