Intraoperative Local Insufflation of Humidified Warmed CO2 Increases Core and Open Wound Temperatures? - A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Temperature
Study Overview
Brief Summary
Eighty adult patients undergoing open colon surgery will be randomized to either:standard warming measures or to additional insufflation of humidified carbon dioxide in the open wound cavity during major abdominal surgery.
PRIMARY AIM is to test if core and local temperature can be increased.
Detailed Description
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. 30ºC, approx. 80-100% relative humidity) via a simple humidifier (sterile warmed water) 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, 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •major open abdominal surgery (colon surgery) in adults patient signed informed consent
Exclusion Criteria
- •acute surgery
Outcomes
Primary Outcomes
Temperature
Time Frame: up to 12 hours after start of surgery
Core temperature measurement via tympanic thermometer, wound temperatures via an infrared camera
Secondary Outcomes
- Time to extubation(up to 30 days after surgery)
- Intraoperative bleeding(up to 12 hours after start of surgery)
- Hospital stay(up to 60 days after surgery)