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Warmed Humidified Carbon Dioxide (CO2) for Open Surgery

2014-08-27 03:25:54 | BioPortfolio

Summary

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 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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Hypothermia

Intervention

humidified warmed CO2

Location

Karolinska University Hospital
Stockholm
Sweden
S-17176

Status

Recruiting

Source

Karolinska University Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:25:54-0400

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PubMed Articles [200 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

Abnormally low BODY TEMPERATURE that is intentionally induced in warm-blooded animals by artificial means. In humans, mild or moderate hypothermia has been used to reduce tissue damages, particularly after cardiac or spinal cord injuries and during subsequent surgeries.

Application of heat to correct hypothermia, accidental or induced.

Lower than normal body temperature, especially in warm-blooded animals; in man usually accidental or unintentional.

A method of lowering core BODY TEMPERATURE by filling the STOMACH with chilled fluids.

Reduction of blood viscosity usually by the addition of cell free solutions. Used clinically (1) in states of impaired microcirculation, (2) for replacement of intraoperative blood loss without homologous blood transfusion, and (3) in cardiopulmonary bypass and hypothermia.

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