Warmed Humidified Carbon Dioxide (CO2) for Open Surgery

Hypothermia Clinical Trial

— S2  

Official title:

Randomized Clinical Study for Core and Topical Warming of the Open Wound Cavity With Warmed Humidified CO2 Versus Control in Colon Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00801424
• Other study ID #: 2008/1258-31-4
• Status: Completed
• Phase: N/A
• First received: December 1, 2008
• Last updated: October 1, 2010
• Start date: November 2008
• Est. completion date: September 2010

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:

1. standard warming measures including heating sheets, warming of fluids, and insulation of limbs and head, or to

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.

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, the 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 of desiccation injury of peritoneal samples, time to extubation, core temperature after surgery, ICU stay, bleeding volume, hospital stay, postoperative pain, infections, shivering, postoperative signs of restored bowel function including bowel movements, flatus, and first meal.

Description:

Eighty 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. 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.

Wound temperatures will be measured every 10 minutes with an infra-red camera positioned approximately 1m above the wound with a camera support. Wound areas and wound edges of stored images will be delineated with a soft ware program. Peritoneal samples (3x3x1mm) will be taken at start of the operation, after 30 minutes and before closure of the abdomen. The samples will immediately be stored in RNA-later solution, and deep frozen for later analysis of epithelial (peritoneal) and endothelial function/tissue damage.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• 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. 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

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 (13)

Hannenberg AA, Sessler DI. Improving perioperative temperature management. Anesth Analg. 2008 Nov;107(5):1454-7. doi: 10.1213/ane.0b013e318181f6f2. — View Citation

Insler SR, Sessler DI. Perioperative thermoregulation and temperature monitoring. Anesthesiol Clin. 2006 Dec;24(4):823-37. Review. — View Citation

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, 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. 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. — 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. 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. — View Citation

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. — View Citation

Sessler DI. Non-pharmacologic prevention of surgical wound infection. Anesthesiol Clin. 2006 Jun;24(2):279-97. Review. — View Citation

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

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Temperature of the core, the open wound cavity including the wound edges during major abdominal surgery		duration surgery up to 12 hours	No
Secondary	Time to extubation		up to 30 days after surgery	No
Secondary	Histological signs of dessication injury of peritoneal samples		duration surgery up to 12 hours	No
Secondary	ICU stay		up to 30 days after surgery	No
Secondary	Pain and need of analgesia		up to 30 days after surgery	No
Secondary	Restoration of bowel function after surgery including flatus, bowel movements, and first meal		up to 30 days after surgery	No
Secondary	Postoperative infections including pneumonia and surgical site infection		up to 30 days after surgery	No
Secondary	Postoperative shivering		up to 24 hours after surgery	No
Secondary	Suture removal		up to 30 days after surgery	No