Clinical Trials Directory

Trials / Completed

CompletedNCT01213628

Local CO2 Increases Core and Wound Temperature

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
80 (actual)
Sponsor
Karolinska University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEhumidified warmed CO2Additional 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.

Timeline

Start date
2007-03-01
Primary completion
2008-05-01
Completion
2008-05-01
First posted
2010-10-04
Last updated
2010-10-04

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT01213628. Inclusion in this directory is not an endorsement.

Local CO2 Increases Core and Wound Temperature (NCT01213628) · Clinical Trials Directory