Clinical trial · Interventional
HEAT HumiGard Evaluation Study
Quality of Recovery and Perioperative Hypothermia in Elective Colectomy Patients: A Feasibility Study of a Blinded Randomised Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Laparoscopic Colorectal Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HumiGard device | Device | — | UNRESOLVED |
| Standard care (with sham HumiGard device) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HumiGard (plus standard care)
- description
- HumiGard device will be used to provide warmed humidified CO2 for insufflation during laparoscopic surgery. The device will be used alongside standard methods of keeping the patient warm in theatre. The theatre team will monitor the patient's temperature at regular time points before, during and after surgery. Warmed fluids, forced air warming devices or warmed blankets will be used as required to maintain normothermia.
- interventionNames
- Device: HumiGard device
- type
- SHAM_COMPARATOR
- label
- Standard Care (with sham HumiGard device).
- description
- Patients will receive standard methods of keeping the patient warm in theatre. The theatre team will monitor the patient's temperature at regular time points before, during and after surgery. Warmed fluids, forced air warming devices or warmed blankets will be used as required to maintain normothermia. A sham HumiGard device will be used in the standard care arm. This will be the same HumiGard device as is in the intervention arm. However, the sham device will be turned "off" so that the gas delivered to the peritoneal cavity for insufflation is not heated or humidified. The sham device will deliver CO2 (as is the case for current standard practice in the hospital) through the HumiGard tubing. The sham device will look and sound the same as the active intervention arm where the HumiGard device is switched "on" and is delivering warm, humidified CO2 to the peritoneal cavity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
The study will recruit patients undergoing an elective laparoscopic colorectal resection operation for any pathology. The patients will be over 18, and able to provide informed consent. Inclusion Criteria: * ≥18 years of age * Participant is willing and able to give informed consent * Scheduled for elective laparoscopic, segmental or total colectomy Exclusion Criteria: * Unable to complete study documentation * Lack of capacity or not willing to give consent * Open procedure planned
References
Publications (0)
Data not yet available