Hypothermia
Conditions
Keywords
abdominal surgery, hypothermia, wound dessication, warming
Brief summary
Eighty adult patients undergoing open colon surgery will be randomized to either: 1. standard warming measures including heating sheets, warming of fluids, and insulation of limbs and head, or to 2. 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.
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.
Interventions
DEVICEhumidified 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
Sponsors
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* major open abdominal surgery (colon surgery) in adults * patient signed informed consent
Exclusion criteria
* acute surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Temperature of the core, the open wound cavity including the wound edges during major abdominal surgery | duration surgery up to 12 hours |
Secondary
| Measure | Time frame |
|---|---|
| Histological signs of dessication injury of peritoneal samples | duration surgery up to 12 hours |
| ICU stay | up to 30 days after surgery |
| Pain and need of analgesia | up to 30 days after surgery |
| Time to extubation | up to 30 days after surgery |
| Postoperative infections including pneumonia and surgical site infection | up to 30 days after surgery |
| Postoperative shivering | up to 24 hours after surgery |
| Suture removal | up to 30 days after surgery |
| Restoration of bowel function after surgery including flatus, bowel movements, and first meal | up to 30 days after surgery |
Countries
Sweden
Outcome results
None listed