Local CO2 Increases Core and Wound Temperature

This study has been completed.
Sponsor:
Information provided by:
Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01213628
First received: October 1, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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 Intervention
Hypothermia
Device: humidified warmed CO2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Intraoperative Local Insufflation of Humidified Warmed CO2 Increases Core and Open Wound Temperatures? - A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Temperature [ Time Frame: up to 12 hours after start of surgery ] [ Designated as safety issue: No ]
    Core temperature measurement via tympanic thermometer, wound temperatures via an infrared camera


Secondary Outcome Measures:
  • Time to extubation [ Time Frame: up to 30 days after surgery ] [ Designated as safety issue: No ]
  • Intraoperative bleeding [ Time Frame: up to 12 hours after start of surgery ] [ Designated as safety issue: No ]
    ml

  • Hospital stay [ Time Frame: up to 60 days after surgery ] [ Designated as safety issue: No ]
    days in hospital


Enrollment: 80
Study Start Date: March 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • acute surgery
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01213628

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Study First Received: October 1, 2010
Last Updated: October 1, 2010
Health Authority: Sweden: Regional Ethical Review Board

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

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

ClinicalTrials.gov processed this record on August 21, 2014