Local CO2 Increases Core and Wound Temperature

Not Applicable

Completed

• Conditions: Hypothermia

• Registration Number: NCT01213628
• Lead Sponsor: Karolinska University Hospital

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 Timeline

• Study Start: 2007-03
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2010-10
• Study First Submitted: 2010-10-01
• Study First Submitted QC: 2010-10-01
• Last Update Submitted: 2010-10-01
• Study First Posted: 2010-10-04
• Last Update Posted: 2010-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• major open abdominal surgery (colon surgery) in adults patient signed informed consent

Exclusion Criteria

• acute surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Temperature	up to 12 hours after start of surgery	Core temperature measurement via tympanic thermometer, wound temperatures via an infrared camera

Secondary Outcome Measures

Name	Time	Method
Time to extubation	up to 30 days after surgery
Intraoperative bleeding	up to 12 hours after start of surgery	ml
Hospital stay	up to 60 days after surgery	days in hospital

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden