HEAT HumiGard Evaluation Study
Nøkkelord
Abstrakt
Beskrivelse
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.
Datoer
Sist bekreftet: | 12/31/2019 |
Først sendt: | 10/29/2019 |
Anslått påmelding sendt: | 11/12/2019 |
Først lagt ut: | 11/14/2019 |
Siste oppdatering sendt: | 01/13/2020 |
Siste oppdatering lagt ut: | 01/17/2020 |
Faktisk studiestartdato: | 11/13/2019 |
Anslått primær ferdigstillelsesdato: | 07/29/2020 |
Anslått sluttdato for studien: | 10/29/2020 |
Tilstand eller sykdom
Intervensjon / behandling
Device: HumiGard (plus standard care)
Other: Standard Care (with sham HumiGard device).
Fase
Armgrupper
Væpne | Intervensjon / behandling |
---|---|
Experimental: 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. | Device: HumiGard (plus standard care) HumiGard is a CE marked device that delivers warmed humidified CO2 during laparoscopic surgery |
Sham Comparator: 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. | Other: 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. |
Kvalifikasjonskriterier
Alder Kvalifisert for studier | 18 Years Til 18 Years |
Kjønn som kan studeres | All |
Godtar sunne frivillige | Ja |
Kriterier | 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 |
Utfall
Primære utfallstiltak
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 [Post-operative day 1]
Sekundære utfallstiltak
1. Number of patients who complete the QoR-40 questionnaire and VAS score [Pre-operatively and post-operative days 1,3,30]
2. Number of patients who have successful continuous intra-operative temperature readings using a urinary temperature probe [Intra-operatively]
3. Number of cases in which the treating surgeon correctly predicted the study arm allocation of the patient (HumiGard vs sham device). [Intra-operatively]