Local CO2 Increases Core and Wound Temperature

NCT01213628 | Completed

• 1 other identifier: Buk1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothermia

Keywords

abdominal surgery; hypothermia; wound desiccation; warming

Outcome Measures

Primary Outcomes (1)

• Temperature

  Core temperature measurement via tympanic thermometer, wound temperatures via an infrared camera

  up to 12 hours after start of surgery

Secondary Outcomes (3)

• Time to extubation

  up to 30 days after surgery

• Intraoperative bleeding

  up to 12 hours after start of surgery

• Hospital stay

  up to 60 days after surgery

Study Arms (1)

Standard heating

EXPERIMENTAL

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

Interventions

humidified warmed CO2 DEVICE

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.

Also known as: CO2, Carbondioxide

Standard heating

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• acute surgery

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, S17176, Sweden

Location

Related Publications (10)

• 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.

  PMID: 19740898 BACKGROUND

• 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.

  PMID: 19589645 BACKGROUND

• 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.

  PMID: 18304752 BACKGROUND

• 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.

  PMID: 15673849 BACKGROUND

• 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.

  PMID: 15529188 BACKGROUND

• 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.

  PMID: 15448528 BACKGROUND

• 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.

  PMID: 15073708 BACKGROUND

• 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.

  PMID: 19782858 BACKGROUND

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

  PMID: 18648241 BACKGROUND

• 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.

  PMID: 22868970 DERIVED

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan A van der Linden, MD PhD

  Karolinska Institute, Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 1, 2010
• First Posted: October 4, 2010
• Study Start: March 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: October 4, 2010

Record last verified: 2010-10

Locations

SE (1)