Local CO2 Increases Core and Wound Temperature

Intraoperative Local Insufflation of Humidified Warmed CO2 Increases Core and Open Wound Temperatures? - A Randomized Clinical Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01213628

Enrollment

Registered

2010-10-04

Start date

2007-03-31

Completion date

2008-05-31

Last updated

2010-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothermia

Keywords

abdominal surgery, hypothermia, wound desiccation, warming

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.

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.

Interventions

DEVICEhumidified 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.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* acute surgery

Design outcomes

Primary

Measure	Time frame	Description
Temperature	up to 12 hours after start of surgery	Core temperature measurement via tympanic thermometer, wound temperatures via an infrared camera

Secondary

Measure	Time frame	Description
Time to extubation	up to 30 days after surgery	—
Intraoperative bleeding	up to 12 hours after start of surgery	ml
Hospital stay	up to 60 days after surgery	days in hospital

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026