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HypothermiaS2NCT00801424

Warmed Humidified Carbon Dioxide (CO2) for Open Surgery

A study testing humidified warmed CO2 in people with Hypothermia, run by Karolinska University Hospital at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. 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
Nov 2008to Sep 2010
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.

Sweden1 site

  • Karolinska University Hospital

    Stockholm, S-17176

Other trials in Sweden

About this study

Official title: Randomized Clinical Study for Core and Topical Warming of the Open Wound Cavity With Warmed Humidified CO2 Versus Control in Colon 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.
Read more

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.

Read the 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.

Conditions
Hypothermia
Being tested
humidified warmed CO2
Keywords
abdominal surgery, hypothermia, wound dessication, 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

    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

Study groups in NCT00801424
Study groupRoleWhat they receive
standard heatingExperimentalStandard 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.

  1. Temperature of the core, the open wound cavity including the wound edges during major abdominal surgery

    Measured: duration surgery up to 12 hours

Secondary outcomes (8)

  1. Time to extubation

    Measured: up to 30 days after surgery

  2. Histological signs of dessication injury of peritoneal samples

    Measured: duration surgery up to 12 hours

  3. ICU stay

    Measured: up to 30 days after surgery

  4. Pain and need of analgesia

    Measured: up to 30 days after surgery

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

    Measured: up to 30 days after surgery

  6. Postoperative infections including pneumonia and surgical site infection

    Measured: up to 30 days after surgery

  7. Postoperative shivering

    Measured: up to 24 hours after surgery

  8. Suture removal

    Measured: up to 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionSep 2010
  4. Study completionSep 2010

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00801424
Sponsor's protocol ID
2008/1258-31-4
Acronym
S2
Status last verified
Oct 2010
First submitted
1 Dec 2008
Last updated
4 Oct 2010
Results posted
No
Data monitoring committee
No

Publications

  • Persson 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 18304752

  • Persson 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 15673849

  • Persson 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 15448528

  • Persson 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 15529188

  • Persson M, van der Linden J. Wound ventilation with ultraclean air for prevention of direct airborne contamination during surgery. Infect Control Hosp Epidemiol. 2004 Apr;25(4):297-301. doi: 10.1086/502395.

    PubMed 15108726

  • Persson M, van der Linden J. Wound ventilation with carbon dioxide: a simple method to prevent direct airborne contamination during cardiac surgery? J Hosp Infect. 2004 Feb;56(2):131-6. doi: 10.1016/j.jhin.2003.10.013.

    PubMed 15019225

  • Persson M, Van Der Linden J. De-airing of a cardiothoracic wound cavity model with carbon dioxide: theory and comparison of a gas diffuser with conventional tubes. J Cardiothorac Vasc Anesth. 2003 Jun;17(3):329-35. doi: 10.1016/s1053-0770(03)00050-8.

    PubMed 12827581

  • Svenarud P, Persson M, Van Der Linden J. Efficiency of a gas diffuser and influence of suction in carbon dioxide deairing of a cardiothoracic wound cavity model. J Thorac Cardiovasc Surg. 2003 May;125(5):1043-9. doi: 10.1067/mtc.2003.50.

    PubMed 12771877

  • Svenarud P, Persson M, van der Linden J. Intermittent or continuous carbon dioxide insufflation for de-airing of the cardiothoracic wound cavity? An experimental study with a new gas-diffuser. Anesth Analg. 2003 Feb;96(2):321-7, table of contents. doi: 10.1097/00000539-200302000-00005.

    PubMed 12538172

  • Hannenberg AA, Sessler DI. Improving perioperative temperature management. Anesth Analg. 2008 Nov;107(5):1454-7. doi: 10.1213/ane.0b013e318181f6f2. No abstract available.

    PubMed 18931198

  • Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76.

    PubMed 18648241

  • Insler SR, Sessler DI. Perioperative thermoregulation and temperature monitoring. Anesthesiol Clin. 2006 Dec;24(4):823-37. doi: 10.1016/j.atc.2006.09.001.

    PubMed 17342966

  • Sessler DI. Non-pharmacologic prevention of surgical wound infection. Anesthesiol Clin. 2006 Jun;24(2):279-97. doi: 10.1016/j.atc.2006.01.005.

    PubMed 16927930

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 2 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 of the core, the open wound cavity including the wound edges during major abdominal surgery (time frame: duration surgery up to 12 hours). 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 NCT00801424, which also lists 13 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.

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