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Local CO2 Increases Core and Wound Temperature

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ClinicalTrials.gov Identifier: NCT01213628
Recruitment Status : Completed
First Posted : October 4, 2010
Last Update Posted : October 4, 2010
Sponsor:
Information provided by:
Karolinska University Hospital

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.


Condition or disease Intervention/treatment Phase
Hypothermia Device: humidified warmed CO2 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Intraoperative Local Insufflation of Humidified Warmed CO2 Increases Core and Open Wound Temperatures? - A Randomized Clinical Trial
Study Start Date : March 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Standard heating
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
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.
Other Names:
  • CO2
  • Carbondioxide




Primary Outcome Measures :
  1. Temperature [ Time Frame: up to 12 hours after start of surgery ]
    Core temperature measurement via tympanic thermometer, wound temperatures via an infrared camera


Secondary Outcome Measures :
  1. Time to extubation [ Time Frame: up to 30 days after surgery ]
  2. Intraoperative bleeding [ Time Frame: up to 12 hours after start of surgery ]
    ml

  3. Hospital stay [ Time Frame: up to 60 days after surgery ]
    days in hospital



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • acute surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01213628


Locations
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Sweden
Karolinska University Hospital
Stockholm, Sweden, S17176
Sponsors and Collaborators
Karolinska University Hospital
Investigators
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Principal Investigator: Jan A van der Linden, MD PhD Karolinska Institute, Karolinska University Hospital

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jan van der Linden, Professor, Karolinska Institute / Karolinska University Hospital, Stockholm, Sweden
ClinicalTrials.gov Identifier: NCT01213628     History of Changes
Other Study ID Numbers: Buk1
First Posted: October 4, 2010    Key Record Dates
Last Update Posted: October 4, 2010
Last Verified: October 2010

Keywords provided by Karolinska University Hospital:
abdominal surgery
hypothermia
wound desiccation
warming

Additional relevant MeSH terms:
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Hypothermia
Body Temperature Changes
Signs and Symptoms