Warmed Humidified Carbon Dioxide (CO2) for Open Surgery (S2)

This study has been completed.
Sponsor:
Information provided by:
Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT00801424
First received: December 1, 2008
Last updated: October 1, 2010
Last verified: October 2010
  Purpose

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.


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

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Temperature of the core, the open wound cavity including the wound edges during major abdominal surgery [ Time Frame: duration surgery up to 12 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to extubation [ Time Frame: up to 30 days after surgery ] [ Designated as safety issue: No ]
  • Histological signs of dessication injury of peritoneal samples [ Time Frame: duration surgery up to 12 hours ] [ Designated as safety issue: No ]
  • ICU stay [ Time Frame: up to 30 days after surgery ] [ Designated as safety issue: No ]
  • Pain and need of analgesia [ Time Frame: up to 30 days after surgery ] [ Designated as safety issue: No ]
  • Restoration of bowel function after surgery including flatus, bowel movements, and first meal [ Time Frame: up to 30 days after surgery ] [ Designated as safety issue: No ]
  • Postoperative infections including pneumonia and surgical site infection [ Time Frame: up to 30 days after surgery ] [ Designated as safety issue: No ]
  • Postoperative shivering [ Time Frame: up to 24 hours after surgery ] [ Designated as safety issue: No ]
  • Suture removal [ Time Frame: up to 30 days after surgery ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: November 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (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. 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

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801424

Locations
Sweden
Karolinska University Hospital
Stockholm, Sweden, S-17176
Sponsors and Collaborators
Karolinska University Hospital
Investigators
Principal Investigator: Jan A van der Linden, MD PhD Karolinska Institute / Karolinska University Hospital
  More Information

Publications:

Responsible Party: Jan van der Linden, Professor, Karolinska Institute / Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT00801424     History of Changes
Other Study ID Numbers: 2008/1258-31-4
Study First Received: December 1, 2008
Last Updated: October 1, 2010
Health Authority: Sweden: Regional Ethical Review Board

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

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

ClinicalTrials.gov processed this record on October 21, 2014