Laparoscopic Colorectal SurgeryHEATNCT04164706
HEAT HumiGard Evaluation Study
A study testing HumiGard device in people with Laparoscopic Colorectal Surgery, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Colorectal Surgery
- What is being tested?
- HumiGard device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Nov 2019to 21 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- Participant is willing and able to give informed consent
- Scheduled for elective laparoscopic, segmental or total colectomy
Who cannot join
- Unable to complete study documentation
- Lack of capacity or not willing to give consent
- Open procedure planned
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Dept of Surgery, Cardiff & Vale University Health Board
Cardiff, CF14 4XW
About this study
Official title: Quality of Recovery and Perioperative Hypothermia in Elective Colectomy Patients: A Feasibility Study of a Blinded Randomised Controlled Trial
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.
Read more
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.
Read the 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
- Being tested
- HumiGard device, Standard care (with sham HumiGard device)
- Keywords
- Colorectal Cancer, Colorectal Surgery, Laparoscopic, Hypothermia
- Medical subject headings
- Colorectal Neoplasms, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HumiGard deviceDevice
Also called HumiGard Surgical Humidification System SH870
HumiGard is a CE marked device that delivers warmed humidified CO2 during laparoscopic surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard care (with sham HumiGard device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-operative day 1
Secondary outcomes (3)
Number of patients who complete the QoR-40 questionnaire and VAS score
The number of patients who successfully complete the QoR-40 questionnaire and VAS score pre-operatively and at post-operative days 1,3,30 will be measured.
Measured: 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
The number of patients who have successful continuous intra-operative temperature readings using a urinary temperature probe will be measured. The feasibility of using these data to identify periods of intraoperative hypothermia will also be assessed.
Measured: Intra-operatively
Number of cases in which the treating surgeon correctly predicted the study arm allocation of the patient (HumiGard vs sham device).
The number of cases in which the treating surgeon correctly predicted the study arm allocation of the patient (HumiGard vs sham device) will be recorded in the case report form.
Measured: Intra-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start14 Nov 2019
- Primary completion10 Nov 2020
- Study completion21 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Colorectal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Feasibility study - 40 patients to be randomised 1:1 to two groups - 50% receiving HumiGard and 50% receiving standard care alone
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Judith White, Cardiff and Vale University Health Board
- Investigators
- Nicola Reeves, MD, Principal investigator, Cardiff and Vale University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164706
- Sponsor's protocol ID
- 19/MAR/7616
- Acronym
- HEAT
- Status last verified
- Mar 2021
- First submitted
- 30 Oct 2019
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Recovery and Perioperative Hypothermia in Elective Colectomy Patients: A Feasibility Study of a Blinded Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04164706
- Acronym / sponsor ID
- HEAT / 19/MAR/7616
- Conditions
- Laparoscopic Colorectal Surgery
- Keywords
- Colorectal Cancer, Colorectal Surgery, Laparoscopic, Hypothermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 21 Jan 2021 (actual)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Feasibility study - 40 patients to be randomised 1:1 to two groups - 50% receiving HumiGard and 50% receiving standard care alone
| Arm | Type | Receives |
|---|---|---|
| HumiGard (plus standard care) | Experimental | Device: HumiGard deviceHumiGard 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. |
| Standard Care (with sham HumiGard device). | Sham comparator | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 years of age
- Participant is willing and able to give informed consent
- Scheduled for elective laparoscopic, segmental or total colectomy
Key exclusion criteria (3 listed)
- Unable to complete study documentation
- Lack of capacity or not willing to give consent
- Open procedure planned
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HumiGard deviceAlso: HumiGard Surgical Humidification System SH870HumiGard is a CE marked device that delivers warmed humidified CO2 during laparoscopic surgery | Device | HumiGard (plus standard care) |
| 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. | Other | Standard Care (with sham HumiGard device). |
Primary outcome
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
Time frame: Post-operative day 1
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.
3 secondary outcomes
Number of patients who complete the QoR-40 questionnaire and VAS score
Time frame: 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
Time frame: Intra-operatively
Number of cases in which the treating surgeon correctly predicted the study arm allocation of the patient (HumiGard vs sham device).
Time frame: Intra-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Reeves, MD principal investigator
Cardiff and Vale University Health Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HumiGard device in people with Laparoscopic Colorectal Surgery, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Post-operative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.