Warmed Humidified Carbon Dioxide (CO2) for Open Surgery (S2)
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Purpose
Eighty adult patients undergoing open colon surgery will be randomized to either:
- standard warming measures including heating sheets, warming of fluids, and insulation of limbs and head, or to
- additional insufflation of humidified carbon dioxide (approx. 36-37ºC, approx. 80-100% relative humidity) via a humidifier with a heated tube (Fisher&Paykel) connected to a gas diffuser (Cardia Innovation AB) that is able to create a local atmosphere of 100% carbon dioxide (humidified ) in the open wound cavity.
PRIMARY AIM The primary aim of this study is to evaluate if humidified carbon dioxide insufflated into an open surgical wound can be used to warm the core, the open wound cavity, and the wound edges during major abdominal surgery.
SECONDARY AIMS Secondary aims are to evaluate possible differences between the groups regarding complications and clinical differences including histological signs of desiccation injury of peritoneal samples, time to extubation, core temperature after surgery, ICU stay, bleeding volume, hospital stay, postoperative pain, infections, shivering, postoperative signs of restored bowel function including bowel movements, flatus, and first meal.
| Condition | Intervention |
|---|---|
|
Hypothermia |
Device: humidified warmed CO2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Randomized Clinical Study for Core and Topical Warming of the Open Wound Cavity With Warmed Humidified CO2 Versus Control in Colon Surgery |
- Temperature of the core, the open wound cavity including the wound edges during major abdominal surgery [ Time Frame: duration surgery up to 12 hours ] [ Designated as safety issue: No ]
- Time to extubation [ Time Frame: up to 30 days after surgery ] [ Designated as safety issue: No ]
- Histological signs of dessication injury of peritoneal samples [ Time Frame: duration surgery up to 12 hours ] [ Designated as safety issue: No ]
- ICU stay [ Time Frame: up to 30 days after surgery ] [ Designated as safety issue: No ]
- Pain and need of analgesia [ Time Frame: up to 30 days after surgery ] [ Designated as safety issue: No ]
- Restoration of bowel function after surgery including flatus, bowel movements, and first meal [ Time Frame: up to 30 days after surgery ] [ Designated as safety issue: No ]
- Postoperative infections including pneumonia and surgical site infection [ Time Frame: up to 30 days after surgery ] [ Designated as safety issue: No ]
- Postoperative shivering [ Time Frame: up to 24 hours after surgery ] [ Designated as safety issue: No ]
- Suture removal [ Time Frame: up to 30 days after surgery ] [ Designated as safety issue: No ]
| Enrollment: | 80 |
| Study Start Date: | November 2008 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: standard heating
Standard intraoperative warming measures including heated sheets, heating with forced warmed air, warming of fluids, and insulation of limbs and head.
|
Device: humidified warmed CO2
Additional insufflation of humidified carbon dioxide (approx. 36-37ºC, approx. 80-100% relative humidity) via a humidifier with a heated tube (Fisher&Paykel) connected to a gas diffuser (Cardia Innovation AB) that is able to create a local atmosphere of 100% carbon dioxide (humidified) in the wound cavity
|
Detailed Description:
Eighty patients undergoing open colon surgery will be randomized to either standard warming measures including heating sheets, warming of fluids, and insulation of limbs and head or to additional insufflation of humidified carbon dioxide (approx. 36-37ºC, approx. 80-100% relative humidity) via a humidifier with a heated tube (Fisher&Paykel) connected to a gas diffuser (Cardia Innovation AB) that is able to create a local atmosphere of 100% carbon dioxide (humidified) in the wound cavity.
Wound temperatures will be measured every 10 minutes with an infra-red camera positioned approximately 1m above the wound with a camera support. Wound areas and wound edges of stored images will be delineated with a soft ware program. Peritoneal samples (3x3x1mm) will be taken at start of the operation, after 30 minutes and before closure of the abdomen. The samples will immediately be stored in RNA-later solution, and deep frozen for later analysis of epithelial (peritoneal) and endothelial function/tissue damage.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- major open abdominal surgery (colon surgery) in adults
- patient signed informed consent
Exclusion Criteria:
- acute surgery
Contacts and Locations| Sweden | |
| Karolinska University Hospital | |
| Stockholm, Sweden, S-17176 | |
| Principal Investigator: | Jan A van der Linden, MD PhD | Karolinska Institute / Karolinska University Hospital |
More Information
Publications:
| Responsible Party: | Jan van der Linden, Professor, Karolinska Institute / Karolinska University Hospital |
| ClinicalTrials.gov Identifier: | NCT00801424 History of Changes |
| Other Study ID Numbers: | 2008/1258-31-4 |
| Study First Received: | December 1, 2008 |
| Last Updated: | October 1, 2010 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by Karolinska University Hospital:
|
abdominal surgery hypothermia wound dessication warming |
Additional relevant MeSH terms:
|
Hypothermia Body Temperature Changes Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013