MedTrace Logo

HEAT HumiGard Evaluation Study

NCT04164706 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2021-03-11

No results posted yet for this study

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 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.

Conditions

  • Laparoscopic Colorectal Surgery

Interventions

DEVICE

HumiGard device

HumiGard is a CE marked device that delivers warmed humidified CO2 during laparoscopic surgery

OTHER

Standard care (with sham HumiGard device)

Standard methods of keeping the patient warm whilst in theatre, including warmed IV fluids, warming blankets/forced air warming devices.

Sponsors & Collaborators

  • Cardiff and Vale University Health Board

    lead OTHER_GOV

Principal Investigators

  • Nicola Reeves, MD · Cardiff and Vale University Health Board

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-14
Primary Completion
2020-11-10
Completion
2021-01-21

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04164706 on ClinicalTrials.gov