Warmed Humidified Carbon Dioxide (CO2) for Open Surgery (S2)
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 dessication, 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 of the core, the open wound cavity including the wound edges during major abdominal surgery
Secondary Outcome Measures
Time to extubation
Histological signs of dessication injury of peritoneal samples
ICU stay
Pain and need of analgesia
Restoration of bowel function after surgery including flatus, bowel movements, and first meal
Postoperative infections including pneumonia and surgical site infection
Postoperative shivering
Suture removal
Full Information
NCT ID
NCT00801424
First Posted
December 1, 2008
Last Updated
October 1, 2010
Sponsor
Karolinska University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00801424
Brief Title
Warmed Humidified Carbon Dioxide (CO2) for Open Surgery
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (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 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 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.
Detailed 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.
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 dessication, 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
Intervention Description
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
Primary Outcome Measure Information:
Title
Temperature of the core, the open wound cavity including the wound edges during major abdominal surgery
Time Frame
duration surgery up to 12 hours
Secondary Outcome Measure Information:
Title
Time to extubation
Time Frame
up to 30 days after surgery
Title
Histological signs of dessication injury of peritoneal samples
Time Frame
duration surgery up to 12 hours
Title
ICU stay
Time Frame
up to 30 days after surgery
Title
Pain and need of analgesia
Time Frame
up to 30 days after surgery
Title
Restoration of bowel function after surgery including flatus, bowel movements, and first meal
Time Frame
up to 30 days after surgery
Title
Postoperative infections including pneumonia and surgical site infection
Time Frame
up to 30 days after surgery
Title
Postoperative shivering
Time Frame
up to 24 hours after surgery
Title
Suture removal
Time Frame
up to 30 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
S-17176
Country
Sweden
12. IPD Sharing Statement
Citations:
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
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
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
15108726
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. doi: 10.1086/502395.
Results Reference
background
PubMed Identifier
15019225
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. doi: 10.1016/j.jhin.2003.10.013.
Results Reference
background
PubMed Identifier
12827581
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. doi: 10.1016/s1053-0770(03)00050-8.
Results Reference
background
PubMed Identifier
12771877
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. doi: 10.1067/mtc.2003.50.
Results Reference
background
PubMed Identifier
12538172
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. doi: 10.1097/00000539-200302000-00005.
Results Reference
background
PubMed Identifier
18931198
Citation
Hannenberg AA, Sessler DI. Improving perioperative temperature management. Anesth Analg. 2008 Nov;107(5):1454-7. doi: 10.1213/ane.0b013e318181f6f2. 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
17342966
Citation
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.
Results Reference
background
PubMed Identifier
16927930
Citation
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.
Results Reference
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Warmed Humidified Carbon Dioxide (CO2) for Open Surgery
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