HEAT HumiGard Evaluation Study

NCT04164706 | Completed DMC

• 1 other identifier: 19/MAR/7616
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Colorectal Surgery

Keywords

Colorectal Cancer; Colorectal Surgery; Laparoscopic; Hypothermia

Outcome Measures

Primary Outcomes (1)

• To assess if a recruitment rate of at least 6 patients per month in a tertiary centre is achievable and identify any barriers to recruitment

  The recruitment rate will be assessed using the "screening and recruitment log" which will record the number of patients recruited each month and reasons for non-recruitment will be described.

  Post-operative day 1

Secondary Outcomes (3)

• Number of patients who complete the QoR-40 questionnaire and VAS score

  Pre-operatively and post-operative days 1,3,30

• Number of patients who have successful continuous intra-operative temperature readings using a urinary temperature probe

  Intra-operatively

• Number of cases in which the treating surgeon correctly predicted the study arm allocation of the patient (HumiGard vs sham device).

  Intra-operatively

Study Arms (2)

HumiGard (plus standard care)

EXPERIMENTAL

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.

Device: HumiGard device

Standard Care (with sham HumiGard device).

SHAM COMPARATOR

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.

Other: Standard care (with sham HumiGard device)

Interventions

HumiGard device DEVICE

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

Also known as: HumiGard Surgical Humidification System SH870

HumiGard (plus standard care)

Standard care (with sham HumiGard device) OTHER

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

Standard Care (with sham HumiGard device).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• Participant is willing and able to give informed consent
• Scheduled for elective laparoscopic, segmental or total colectomy

You may not qualify if:

• Unable to complete study documentation
• Lack of capacity or not willing to give consent
• Open procedure planned

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead

Study Sites (1)

Dept of Surgery, Cardiff & Vale University Health Board

Cardiff, CF14 4XW, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Hypothermia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Nicola Reeves, MD

  Cardiff and Vale University Health Board

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Everyone will be blinded except for one member of the theatre staff who will operate the HumiGard, and the research team member who performs the randomisation process.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trial Manager

Model Details: Feasibility study - 40 patients to be randomised 1:1 to two groups - 50% receiving HumiGard and 50% receiving standard care alone

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 15, 2019
• Study Start: November 14, 2019
• Primary Completion: November 10, 2020
• Study Completion: January 21, 2021
• Last Updated: March 11, 2021

Record last verified: 2021-03

Locations

GB (1)