Local CO2 Increases Core and Wound Temperature
Primary Purpose
Hypothermia
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
humidified warmed CO2
Sponsored by
About this trial
This is an interventional treatment trial for Hypothermia focused on measuring abdominal surgery, hypothermia, wound desiccation, warming
Eligibility Criteria
Inclusion Criteria:
- major open abdominal surgery (colon surgery) in adults patient signed informed consent
Exclusion Criteria:
- acute surgery
Sites / Locations
- Karolinska University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Standard heating
Arm Description
Standard intraoperative warming measures including heated sheets, heating with forced warmed air, warming of fluids, and insulation of limbs and head.
Outcomes
Primary Outcome Measures
Temperature
Core temperature measurement via tympanic thermometer, wound temperatures via an infrared camera
Secondary Outcome Measures
Time to extubation
Intraoperative bleeding
ml
Hospital stay
days in hospital
Full Information
NCT ID
NCT01213628
First Posted
October 1, 2010
Last Updated
October 1, 2010
Sponsor
Karolinska University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01213628
Brief Title
Local CO2 Increases Core and Wound Temperature
Official Title
Intraoperative Local Insufflation of Humidified Warmed CO2 Increases Core and Open Wound Temperatures? - A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Karolinska University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia
Keywords
abdominal surgery, hypothermia, wound desiccation, warming
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard heating
Arm Type
Experimental
Arm Description
Standard intraoperative warming measures including heated sheets, heating with forced warmed air, warming of fluids, and insulation of limbs and head.
Intervention Type
Device
Intervention Name(s)
humidified warmed CO2
Other Intervention Name(s)
CO2, Carbondioxide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Temperature
Description
Core temperature measurement via tympanic thermometer, wound temperatures via an infrared camera
Time Frame
up to 12 hours after start of surgery
Secondary Outcome Measure Information:
Title
Time to extubation
Time Frame
up to 30 days after surgery
Title
Intraoperative bleeding
Description
ml
Time Frame
up to 12 hours after start of surgery
Title
Hospital stay
Description
days in hospital
Time Frame
up to 60 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
major open abdominal surgery (colon surgery) in adults patient signed informed consent
Exclusion Criteria:
acute surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan A van der Linden, MD PhD
Organizational Affiliation
Karolinska Institute, Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
S17176
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
19740898
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. No abstract available.
Results Reference
background
PubMed Identifier
19589645
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.
Results Reference
background
PubMed Identifier
18304752
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.
Results Reference
background
PubMed Identifier
15673849
Citation
Persson M, van der Linden J. Can wound desiccation be averted during cardiac surgery? An experimental study. Anesth Analg. 2005 Feb;100(2):315-320. doi: 10.1213/01.ANE.0000140243.97570.DE.
Results Reference
background
PubMed Identifier
15529188
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. doi: 10.1007/s00464-003-9334-z. Epub 2004 Nov 11.
Results Reference
background
PubMed Identifier
15448528
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. doi: 10.1097/00000542-200410000-00020.
Results Reference
background
PubMed Identifier
15073708
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. doi: 10.1053/j.jvca.2004.01.024.
Results Reference
background
PubMed Identifier
19782858
Citation
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.
Results Reference
background
PubMed Identifier
18648241
Citation
Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76.
Results Reference
background
PubMed Identifier
22868970
Citation
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.
Results Reference
derived
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Local CO2 Increases Core and Wound Temperature
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