Local CO2 Increases Core and Wound Temperature

Hypothermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01213628
• Other study ID #: Buk1
• Status: Completed
• Phase: N/A
• First received: October 1, 2010
• Last updated: October 1, 2010
• Start date: March 2007
• Est. completion date: May 2008

Study information

• Verified date: October 2010
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• acute surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypothermia

Intervention

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.

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (9)

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. — View Citation

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. Epub 2004 Nov 11. — View Citation

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. — View Citation

Persson M, van der Linden J. Can wound desiccation be averted during cardiac surgery? An experimental study. Anesth Analg. 2005 Feb;100(2):315-20. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Sessler DI. New surgical thermal management guidelines. Lancet. 2009 Sep 26;374(9695):1049-50. doi: 10.1016/S0140-6736(09)61686-X. — View Citation

Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Temperature	Core temperature measurement via tympanic thermometer, wound temperatures via an infrared camera	up to 12 hours after start of surgery	No
Secondary	Time to extubation		up to 30 days after surgery	No
Secondary	Intraoperative bleeding	ml	up to 12 hours after start of surgery	No
Secondary	Hospital stay	days in hospital	up to 60 days after surgery	No