Warmed Humidified Carbon Dioxide (CO2) for Open Surgery

NCT00801424 | Completed

• 1 other identifier: 2008/1258-31-4
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Eighty adult patients undergoing open colon surgery will be randomized to either:

1. 1.standard warming measures including heating sheets, warming of fluids, and insulation of limbs and head, or to
2. 2.additional insufflation of humidified carbon dioxide (approx. 36-37ºC, approx. 80-100% relative humidity) via a humidifier with a heated tube (Fisher\&Paykel) 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.

Conditions

Hypothermia

Keywords

abdominal surgery; hypothermia; wound dessication; warming

Outcome Measures

Primary Outcomes (1)

• Temperature of the core, the open wound cavity including the wound edges during major abdominal surgery

  duration surgery up to 12 hours

Secondary Outcomes (8)

• Time to extubation

  up to 30 days after surgery

• Histological signs of dessication injury of peritoneal samples

  duration surgery up to 12 hours

• ICU stay

  up to 30 days after surgery

• Pain and need of analgesia

  up to 30 days after surgery

• Restoration of bowel function after surgery including flatus, bowel movements, and first meal

  up to 30 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. 36-37ºC, approx. 80-100% relative humidity) via a humidifier with a heated tube (Fisher\&Paykel) 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

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, S-17176, Sweden

Location

Related Publications (13)

• 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, 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, 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, van der Linden J. Wound ventilation with ultraclean air for prevention of direct airborne contamination during surgery. Infect Control Hosp Epidemiol. 2004 Apr;25(4):297-301. doi: 10.1086/502395.

  PMID: 15108726 BACKGROUND

• Persson M, van der Linden J. Wound ventilation with carbon dioxide: a simple method to prevent direct airborne contamination during cardiac surgery? J Hosp Infect. 2004 Feb;56(2):131-6. doi: 10.1016/j.jhin.2003.10.013.

  PMID: 15019225 BACKGROUND

• Persson M, Van Der Linden J. De-airing of a cardiothoracic wound cavity model with carbon dioxide: theory and comparison of a gas diffuser with conventional tubes. J Cardiothorac Vasc Anesth. 2003 Jun;17(3):329-35. doi: 10.1016/s1053-0770(03)00050-8.

  PMID: 12827581 BACKGROUND

• Svenarud P, Persson M, Van Der Linden J. Efficiency of a gas diffuser and influence of suction in carbon dioxide deairing of a cardiothoracic wound cavity model. J Thorac Cardiovasc Surg. 2003 May;125(5):1043-9. doi: 10.1067/mtc.2003.50.

  PMID: 12771877 BACKGROUND

• Svenarud P, Persson M, van der Linden J. Intermittent or continuous carbon dioxide insufflation for de-airing of the cardiothoracic wound cavity? An experimental study with a new gas-diffuser. Anesth Analg. 2003 Feb;96(2):321-7, table of contents. doi: 10.1097/00000539-200302000-00005.

  PMID: 12538172 BACKGROUND

• Hannenberg AA, Sessler DI. Improving perioperative temperature management. Anesth Analg. 2008 Nov;107(5):1454-7. doi: 10.1213/ane.0b013e318181f6f2. No abstract available.

  PMID: 18931198 BACKGROUND

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

  PMID: 18648241 BACKGROUND

• Insler SR, Sessler DI. Perioperative thermoregulation and temperature monitoring. Anesthesiol Clin. 2006 Dec;24(4):823-37. doi: 10.1016/j.atc.2006.09.001.

  PMID: 17342966 BACKGROUND

• Sessler DI. Non-pharmacologic prevention of surgical wound infection. Anesthesiol Clin. 2006 Jun;24(2):279-97. doi: 10.1016/j.atc.2006.01.005.

  PMID: 16927930 BACKGROUND

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: December 1, 2008
• First Posted: December 3, 2008
• Study Start: November 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 4, 2010

Record last verified: 2010-10

Locations

SE (1)