Local CO2 Increases Core and Wound Temperature

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

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.

Study Overview

• Status: Completed
• Conditions: Hypothermia
• Intervention / Treatment: Device: humidified warmed CO2

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, S17176
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• acute surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; Other Names: CO2; Carbondioxide

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Investigators: Principal Investigator: Jan A van der Linden, MD PhD, Karolinska Institute, Karolinska University Hospital

Publications and helpful links

General Publications

• Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76.
• Persson M, van der Linden J. Perioperative cooling to prevent adhesion formation may be counterproductive for the clinical outcome. Hum Reprod. 2009 Nov;24(11):2965; author reply 2966-7. doi: 10.1093/humrep/dep326. Epub 2009 Sep 9. No abstract available.
• Persson M, van der Linden J. Intraoperative field flooding with warm humidified CO2 may help to prevent adhesion formation after open surgery. Med Hypotheses. 2009 Oct;73(4):521-3. doi: 10.1016/j.mehy.2009.06.009. Epub 2009 Jul 8.
• Persson M, van der Linden J. Intraoperative CO2 insufflation can decrease the risk of surgical site infection. Med Hypotheses. 2008;71(1):8-13. doi: 10.1016/j.mehy.2007.12.016. Epub 2008 Mar 4.
• Persson M, van der Linden J. Can wound desiccation be averted during cardiac surgery? An experimental study. Anesth Analg. 2005 Feb;100(2):315-320. doi: 10.1213/01.ANE.0000140243.97570.DE.
• Persson M, Svenarud P, Flock JI, van der Linden J. Carbon dioxide inhibits the growth rate of Staphylococcus aureus at body temperature. Surg Endosc. 2005 Jan;19(1):91-4. doi: 10.1007/s00464-003-9334-z. Epub 2004 Nov 11.
• Persson M, Elmqvist H, van der Linden J. Topical humidified carbon dioxide to keep the open surgical wound warm: the greenhouse effect revisited. Anesthesiology. 2004 Oct;101(4):945-9. doi: 10.1097/00000542-200410000-00020.
• Persson M, Svenarud P, van der Linden J. What is the optimal device for carbon dioxide deairing of the cardiothoracic wound and how should it be positioned? J Cardiothorac Vasc Anesth. 2004 Apr;18(2):180-4. doi: 10.1053/j.jvca.2004.01.024.
• Sessler DI. New surgical thermal management guidelines. Lancet. 2009 Sep 26;374(9695):1049-50. doi: 10.1016/S0140-6736(09)61686-X. No abstract available.
• Frey JM, Janson M, Svanfeldt M, Svenarud PK, van der Linden JA. Intraoperative local insufflation of warmed humidified CO(2) increases open wound and core temperatures: a randomized clinical trial. World J Surg. 2012 Nov;36(11):2567-75. doi: 10.1007/s00268-012-1735-5.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: October 1, 2010
• First Submitted That Met QC Criteria: October 1, 2010
• First Posted (Estimate): October 4, 2010

Study Record Updates

• Last Update Posted (Estimate): October 4, 2010
• Last Update Submitted That Met QC Criteria: October 1, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: hypothermia; abdominal surgery; warming; wound desiccation
• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: Buk1