HEAT HumiGard Evaluation Study

NCT ID: NCT04164706

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-14
• Study Completion Date: 2021-01-21

Brief 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.

Detailed Description

Laparoscopic surgery involves filling the peritoneal cavity with carbon dioxide (CO2) gas (insufflation) to increase the working and viewing space in the abdomen. It is standard care in the United Kingdom (UK) to use dry, unwarmed CO2. There is evidence that dry, unwarmed insufflation is associated with tissue desiccation and intraoperative hypothermia showing that insufflation of cool dry gas resulted in a temperature drop of 1.3-1.7°C. Despite active warming methods, perioperative hypothermia is common. One study demonstrated that nearly half of patients had continuous core temperatures of 36°C for more than an hour.

HumiGard (Fisher and Paykel Healthcare) is a CE marked medical device designed to humidify and heat CO2 for insufflation. A meta-analysis included 13 studies (total of 796 patients) comparing warmed, humidified CO2 insufflation compared to unwarmed, dry CO2 in patients having a range of procedures. There was a significant difference in mean core temperature change, and an effect size of +0.3°C (95% confidence interval [CI]: 0.1-0.6). This was more pronounced in studies of long procedures (80 min). Another meta-analysis of 15 studies (1026 patients) demonstrated a small beneficial effect on immediate post-operative pain but not at day 1 or 2. Warmed, humidified CO2 reduced the risk of intraoperative hypothermia (p=0.004) but postoperative core temperatures were not significantly different (10 studies, 718 patients). No differences were observed in analgesic consumption, length of stay, or procedure duration.

This is a blinded, randomised controlled feasibility study on 40 patients receiving laparoscopic colorectal resectional surgery at a single site (University Hospital of Wales) and treated with either the HumiGard device plus standard care (20 patients) or a sham HumiGard device plus standard care (20 patients).

This study will assess various aspects of a proposed larger pragmatic blinded, RCT evaluating whether HumiGard insufflation device, when used with standard care, can improve patients' quality of recovery after laparoscopic colectomy surgery.

The feasibility study will aim to highlight the most appropriate outcomes to be measured in a main RCT, particularly looking at the role of Quality of Recovery (QoR-40) questionnaire or continuous temperature measurements. The investigators will assess whether the outcomes of the study are suitable, achievable and measurable. The study will assess recruitment, ability to blind operating surgeon with a sham HumiGard device, use of urinary temperature probe compared to standard temperature monitoring in theatre, use of QoR-40 and visual analogue score (VAS) pain score by patients preoperatively (for a baseline score) and on post-operative day (POD) 1, 3 and 30, analgesia use, and intraoperative patient warming techniques. Length of stay in hospital from procedure to discharge (or until medically fit for discharge) will also be recorded and reported.

Furthermore, methods for analysing the postoperative complication rate will be evaluated. Complications will be recorded at POD1, POD3, upon discharge and POD30. Their severity will be graded using the Clavien-Dindo scale, a widely used and valid method for grading severity of surgical complications which helps to reduce subjectivity. The Comprehensive Complication Index (CCI) will then be used to create a composite score (0-100) for each patient.

Conditions

Laparoscopic Colorectal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HumiGard (plus standard care)

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.

Group Type: EXPERIMENTAL

HumiGard device

Intervention Type: DEVICE

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

Standard Care (with sham HumiGard device).

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.

Group Type: SHAM_COMPARATOR

Standard care (with sham HumiGard device)

Intervention Type: OTHER

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

Interventions

HumiGard device

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

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

HumiGard Surgical Humidification System SH870

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardiff and Vale University Health Board

OTHER_GOV

Sponsor Role: lead

Responsible Party

Judith White

Trial Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicola Reeves, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiff and Vale University Health Board

Locations

Dept of Surgery, Cardiff & Vale University Health Board

Cardiff, , United Kingdom

Countries

United Kingdom

Other Identifiers

19/MAR/7616

Identifier Type: -

Identifier Source: org_study_id