Skip to main content
OpenTrials
Completed

NCT Number: NCT00801424

Warmed Humidified Carbon Dioxide (CO2) for Open Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypothermia Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Stockholm, S-17176, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • acute surgery

Treatment and study plan

humidified warmed CO2

Device

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 outcomes

  1. 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 outcomes

  1. Time to extubation

    Time frame: up to 30 days after surgery

  2. Histological signs of dessication injury of peritoneal samples

    Time frame: duration surgery up to 12 hours

  3. ICU stay

    Time frame: up to 30 days after surgery

  4. Pain and need of analgesia

    Time frame: up to 30 days after surgery

  5. Restoration of bowel function after surgery including flatus, bowel movements, and first meal

    Time frame: up to 30 days after surgery

  6. Postoperative infections including pneumonia and surgical site infection

    Time frame: up to 30 days after surgery

  7. Postoperative shivering

    Time frame: up to 24 hours after surgery

  8. Suture removal

    Time frame: up to 30 days after surgery

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study title

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

Acronym: S2

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 3, 2008
Registry last updated
Oct 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.