Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04164706 |
| Other study ID # |
19/MAR/7616 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 14, 2019 |
| Est. completion date |
January 21, 2021 |
Study information
| Verified date |
March 2021 |
| Source |
Cardiff and Vale University Health Board |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
