HypothermiaNCT01213628
Local CO2 Increases Core and Wound Temperature
A study testing humidified warmed CO2 in people with Hypothermia, run by Karolinska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypothermia
- What is being tested?
- humidified warmed CO2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2007to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- major open abdominal surgery (colon surgery) in adults patient signed informed consent
Who cannot join
- acute surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Local Insufflation of Humidified Warmed CO2 Increases Core and Open Wound Temperatures? - A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Hypothermia
- Being tested
- humidified warmed CO2
- Keywords
- abdominal surgery, hypothermia, wound desiccation, warming
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
humidified warmed CO2Device
Also called CO2, Carbondioxide
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 group | Role | What they receive |
|---|---|---|
| Standard heating | Experimental | Standard intraoperative warming measures including heated sheets, heating with forced warmed air, warming of fluids, and insulation of limbs and head. Receives: Device: humidified warmed CO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature
Core temperature measurement via tympanic thermometer, wound temperatures via an infrared camera
Measured: up to 12 hours after start of surgery
Secondary outcomes (3)
Time to extubation
Measured: up to 30 days after surgery
Intraoperative bleeding
ml
Measured: up to 12 hours after start of surgery
Hospital stay
days in hospital
Measured: up to 60 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startMar 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jan A van der Linden, MD PhD, Principal investigator, Karolinska Institute, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213628
- Sponsor's protocol ID
- Buk1
- Status last verified
- Oct 2010
- First submitted
- 1 Oct 2010
- Last updated
- 4 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Persson M, van der Linden J. Perioperative cooling to prevent adhesion formation may be counterproductive for the clinical outcome. Hum Reprod. 2009 Nov;24(11):2965; author reply 2966-7. doi: 10.1093/humrep/dep326. Epub 2009 Sep 9. No abstract available.
PubMed 19740898Persson M, van der Linden J. Intraoperative field flooding with warm humidified CO2 may help to prevent adhesion formation after open surgery. Med Hypotheses. 2009 Oct;73(4):521-3. doi: 10.1016/j.mehy.2009.06.009. Epub 2009 Jul 8.
PubMed 19589645Persson M, van der Linden J. Intraoperative CO2 insufflation can decrease the risk of surgical site infection. Med Hypotheses. 2008;71(1):8-13. doi: 10.1016/j.mehy.2007.12.016. Epub 2008 Mar 4.
PubMed 18304752Persson M, van der Linden J. Can wound desiccation be averted during cardiac surgery? An experimental study. Anesth Analg. 2005 Feb;100(2):315-320. doi: 10.1213/01.ANE.0000140243.97570.DE.
PubMed 15673849Persson M, Svenarud P, Flock JI, van der Linden J. Carbon dioxide inhibits the growth rate of Staphylococcus aureus at body temperature. Surg Endosc. 2005 Jan;19(1):91-4. doi: 10.1007/s00464-003-9334-z. Epub 2004 Nov 11.
PubMed 15529188Persson M, Elmqvist H, van der Linden J. Topical humidified carbon dioxide to keep the open surgical wound warm: the greenhouse effect revisited. Anesthesiology. 2004 Oct;101(4):945-9. doi: 10.1097/00000542-200410000-00020.
PubMed 15448528Persson M, Svenarud P, van der Linden J. What is the optimal device for carbon dioxide deairing of the cardiothoracic wound and how should it be positioned? J Cardiothorac Vasc Anesth. 2004 Apr;18(2):180-4. doi: 10.1053/j.jvca.2004.01.024.
PubMed 15073708Sessler DI. New surgical thermal management guidelines. Lancet. 2009 Sep 26;374(9695):1049-50. doi: 10.1016/S0140-6736(09)61686-X. No abstract available.
PubMed 19782858Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76.
PubMed 18648241Frey JM, Janson M, Svanfeldt M, Svenarud PK, van der Linden JA. Intraoperative local insufflation of warmed humidified CO(2) increases open wound and core temperatures: a randomized clinical trial. World J Surg. 2012 Nov;36(11):2567-75. doi: 10.1007/s00268-012-1735-5.
PubMed 22868970
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Local Insufflation of Humidified Warmed CO2 Increases Core and Open Wound Temperatures? - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01213628
- Acronym / sponsor ID
- Buk1
- Conditions
- Hypothermia
- Keywords
- abdominal surgery, hypothermia, wound desiccation, warming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 4 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard heating | Experimental | Device: humidified warmed CO2Standard intraoperative warming measures including heated sheets, heating with forced warmed air, warming of fluids, and insulation of limbs and head. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- major open abdominal surgery (colon surgery) in adults patient signed informed consent
Key exclusion criteria (1 listed)
- acute surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| humidified warmed CO2Also: CO2, CarbondioxideAdditional 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. | Device | Standard heating |
Primary outcome
Temperature
Time frame: up to 12 hours after start of surgery
Core temperature measurement via tympanic thermometer, wound temperatures via an infrared camera
3 secondary outcomes
Time to extubation
Time frame: up to 30 days after surgery
Intraoperative bleeding
Time frame: up to 12 hours after start of surgery
Hospital stay
Time frame: up to 60 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2010.
- Background: PubMed 19740898Persson M, van der Linden J. Perioperative cooling to prevent adhesion formation may be counterproductive for the clinical outcome. Hum Reprod. 2009 Nov;24(11):2965; author reply 2966-7. doi: 10.1093/humrep/dep326. Epub 2009 Sep 9. No abstract available.
- Background: PubMed 19589645Persson M, van der Linden J. Intraoperative field flooding with warm humidified CO2 may help to prevent adhesion formation after open surgery. Med Hypotheses. 2009 Oct;73(4):521-3. doi: 10.1016/j.mehy.2009.06.009. Epub 2009 Jul 8.
- Background: PubMed 18304752Persson M, van der Linden J. Intraoperative CO2 insufflation can decrease the risk of surgical site infection. Med Hypotheses. 2008;71(1):8-13. doi: 10.1016/j.mehy.2007.12.016. Epub 2008 Mar 4.
- Background: PubMed 15673849Persson M, van der Linden J. Can wound desiccation be averted during cardiac surgery? An experimental study. Anesth Analg. 2005 Feb;100(2):315-320. doi: 10.1213/01.ANE.0000140243.97570.DE.
- Background: PubMed 15529188Persson M, Svenarud P, Flock JI, van der Linden J. Carbon dioxide inhibits the growth rate of Staphylococcus aureus at body temperature. Surg Endosc. 2005 Jan;19(1):91-4. doi: 10.1007/s00464-003-9334-z. Epub 2004 Nov 11.
- Background: PubMed 15448528Persson M, Elmqvist H, van der Linden J. Topical humidified carbon dioxide to keep the open surgical wound warm: the greenhouse effect revisited. Anesthesiology. 2004 Oct;101(4):945-9. doi: 10.1097/00000542-200410000-00020.
- Background: PubMed 15073708Persson M, Svenarud P, van der Linden J. What is the optimal device for carbon dioxide deairing of the cardiothoracic wound and how should it be positioned? J Cardiothorac Vasc Anesth. 2004 Apr;18(2):180-4. doi: 10.1053/j.jvca.2004.01.024.
- Background: PubMed 19782858Sessler DI. New surgical thermal management guidelines. Lancet. 2009 Sep 26;374(9695):1049-50. doi: 10.1016/S0140-6736(09)61686-X. No abstract available.
- Background: PubMed 18648241Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76.
- Derived from this study: PubMed 22868970Frey JM, Janson M, Svanfeldt M, Svenarud PK, van der Linden JA. Intraoperative local insufflation of warmed humidified CO(2) increases open wound and core temperatures: a randomized clinical trial. World J Surg. 2012 Nov;36(11):2567-75. doi: 10.1007/s00268-012-1735-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan A van der Linden, MD PhD principal investigator
Karolinska Institute, Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing humidified warmed CO2 in people with Hypothermia, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperature (time frame: up to 12 hours after start of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01213628, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2010.