Local CO2 Increases Core and Wound Temperature
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|ClinicalTrials.gov Identifier: NCT01213628|
Recruitment Status : Completed
First Posted : October 4, 2010
Last Update Posted : October 4, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypothermia||Device: humidified warmed CO2||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Intraoperative Local Insufflation of Humidified Warmed CO2 Increases Core and Open Wound Temperatures? - A Randomized Clinical Trial|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||May 2008|
Experimental: Standard heating
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
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.
- Temperature [ Time Frame: up to 12 hours after start of surgery ]Core temperature measurement via tympanic thermometer, wound temperatures via an infrared camera
- Time to extubation [ Time Frame: up to 30 days after surgery ]
- Intraoperative bleeding [ Time Frame: up to 12 hours after start of surgery ]ml
- Hospital stay [ Time Frame: up to 60 days after surgery ]days in hospital
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01213628
|Karolinska University Hospital|
|Stockholm, Sweden, S17176|
|Principal Investigator:||Jan A van der Linden, MD PhD||Karolinska Institute, Karolinska University Hospital|