Local CO2 Increases Core and Wound Temperature

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intraoperative Local Insufflation of Humidified Warmed CO2 Increases Core and Open Wound Temperatures? - A Randomized Clinical Trial

Conditions
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Hypothermia

Intervention / Treatment
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* Device: humidified warmed CO2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: major open abdominal surgery (colon surgery) in adults patient signed informed consent Exclusion Criteria: acute surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard heating<br>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<br>* Additional insufflation of humidified carbon dioxide (approx. 30ºC, approx. 80-100% relative humidity) via a simple humidifier (sterile water in plastic bottle) 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.<br>* Other names: Carbondioxide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperature | Core temperature measurement via tympanic thermometer, wound temperatures via an infrared camera | up to 12 hours after start of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to extubation |  | up to 30 days after surgery | 
| Intraoperative bleeding | ml | up to 12 hours after start of surgery | 
| Hospital stay | days in hospital | up to 60 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abdominal surgery, hypothermia, wound desiccation, warming