Peritoneal InflammationNCT02975947
Effect of Warmed Humidified CO2 on Peritoneum During Laparotomy
A study testing Humidified, warmed CO2 insufflation of open peritoneum using Fisher & Paykel's HUMIGARD (Fisher & Paykel Healthcare Ltd, Auckland, New Zealand) and Standard heating in people with Peritoneal Inflammation and Peritoneum; Injury, run by Concord Repatriation General Hospital at 1 site in Australia.
Trial summary
The operating theatre is deliberately made to be cold and dry to prevent bacteria from growing. The problem with this is that during open abdominal surgery, the intestine and the overlying peritoneum is exposed to cold dry air. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Inflammation, Peritoneum; Injury
- What is being tested?
- Humidified, warmed CO2 insufflation of open peritoneum using Fisher & Paykel's HUMIGARD (Fisher & Paykel Healthcare Ltd, Auckland, New Zealand) and Standard heating
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2013to Jun 2016
- 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
- Adults above age 18.
- Elective patients.
- Pathologies: colorectal carcinoma, polyposis syndromes, diverticular diseases, prolapses, and patients with inflammatory bowel disease undergoing elective resection.
- For colorectal carcinoma, all patients whether they are having curative or palliative surgery will be included.
- Patients undergoing open elective colectomy, with or without stoma formation/ bowel anastomosis.
Who cannot join
- Patients undergoing acute surgery (emergency surgery).
- Patients undergoing Laparoscopic colectomy (multiport, single incision and also hand assisted) as all these patients receive heated humidified CO2.
- For COPD patients, the exclusion criteria would be patients: (1) On home oxygen, (2) Type 2 respiratory failure (CO2 retainers) (3) FEV1<1L, or FEV1/FVC <50% of predicted
Trial locations and contacts
1 site in 1 country.
Australia1 site
Concord Repatriation General Hospital
Sydney, New South Wales, 2138
About this study
Official title: Effect of Intraoperative Humidified CO2 Insufflation in Open Laparotomy Colorectal Surgery Patients: a Randomized Controlled Trial
The operating theatre is deliberately made to be cold and dry to prevent bacteria from growing. The problem with this is that during open abdominal surgery, the intestine and the overlying peritoneum is exposed to cold dry air. Surgeons try to stop the bowel/peritoneum from drying by applying warmed saline packs periodically to the bowel. However, this is not always possible. Sometimes, the surgeon has to perform an important component of the procedure (attach bowel/blood vessels together etc) and the bowel/peritoneum visibly dries. When bowel/peritoneum dries damage occurs, inducing inflammation. Inflamed bowel/peritoneum causes the bowel to stick together and form adhesions. Bowel adhesions can cause bowel obstruction. This vicious cycle is repeated when the patient undergoes repetitive open abdominal operations.
This study aimed to be the first human study to:
Read more
- Demonstrate that peritoneal inflammation occurs during open abdominal surgery and also to demonstrate that pro-inflammatory cells (polymorphs, macrophages) are activated during the progress of the operation. This study aims to show that mRNA(using Q-PCR) is increased for pro-inflammatory cytokines. This study also aim to show that proinflammatory cytokines (Interleukin(IL)-1,2,6,9,10, and TNF by ELISA/confirmed using Western Blotting) are elevated during the course of the operation.
- Demonstrate that the mechanism of bowel/peritoneal inflammation is causally related to the bowel/peritoneum drying (dessication).
This study will attempt to prove this by using humidified, warmed carbon dioxide gas which will warm and moisten the peritoneum/bowel. It is proposed that this will arrest the peritoneal injury and the inflammation. The investigators will attain peritoneal samples during open colorectal operations. The investigators will obtain samples at the beginning and end of the operation. This study design is a randomized controlled trial, where half the patients will receive humidified, warmed carbon dioxide gas during surgery, and the other half will get standard open surgery without carbon dioxide. 40 patients will be recruited in this study. Half (20) will get CO2, and other half (20) will get standard open surgery.
Read the detailed description
Forty patients undergoing open colorectal surgery will be recruited in this randomized controlled trial.
The study group will receive warmed (37°C), humidified (98% RH) carbon dioxide. The delivered gas will be defined by the United States Pharmacopeia and National Formulary, which requires impurity of less than 200 parts per million, including water vapour. This medical grade CO2 will be warmed to 37°C and humidified to 98% RH using humidification system. The sterility of the system will be assessed regularly as per protocol.
The control group will receive no gas insufflation into the open laparotomy wound. This is current standard practice for all patients undergoing open laparotomy for colorectal resection.
The device that will be used for insufflation of sterile, humidified, warmed CO2 is the Fisher \& Paykel's HUMIGARD (Fisher \& Paykel Healthcare Ltd, Auckland, New Zealand).
It consists of a bacterial filter and a humidification chamber filed with 180mL sterile water, positioned on a humidifier controller that includes an integrated temperature and flow sensor. The outlet of the humidification chamber is connected to a thermally insulated 2.5m-long heated insufflation tube that maintains temperature and humidity of the gas to its outlet. The warm and humidified CO2 enters a gas diffuser (ST300DF VITA-diffuserTM, Cardia Innovation AB, Stockholm, Sweden) consisting of a 25cm-long polyvinylchloride tube (inner diameter of 2.5mm) with polyurethane foam at its end. The cylindrical polyurethane foam tip diverts the gas jet in multiple directions via the many small paths inside the foam. The gas is thus uniformly distributed and the large diffuser surface area greatly reduces the velocity of the outflow. Thus the system delivers humidified CO2 at 100% relative humidity and 37C to the surgical wound. The gas diffuser will be positioned inside the open abdominal wound cavity (in the right cranial quadrant) at a depth of approximately 4cm from the skin as soon as the abdominal wall retraction has been done. The insufflation of warm humidified CO2 will then start and continue until the abdominal wall retractors are removed and abdominal wall is commenced to be closed.
Calculation of Power: The investigators estimated sample size of 40 patients for 80% power using the literatures' reported standard deviation of levels of 3-chlorotyrosine (which is one of the study's primary biochemical markers of inflammation)
ANALYSIS OF BIOCHEMICAL AND MOLECULAR MARKERS: Where acquired, samples of the human tissue obtained (above) will be homogenised and assigned to biochemistry and molecular analyses. Total RNA will be extracted using a commercial kit, converted to cloned DNA and then probed for various pro-inflammatory genes. Where a change in gene regulation is noted, the investigators will assess the corresponding change in protein level using a combined approach consisting of multiplex ELISA to quantify changes in protein levels and further confirmation with Western blotting using corresponding specific antibodies.
STATISTICAL ANALYSIS: Statistical analysis will be performed using SPSS for Windows version 18.0 GradPack (IBM, New York, USA). Non-parametric continuous variables will be tested using Mann-Whitney U tests and parametric continuous variable will be tested using t-test/ANOVA. Categorical variables will be tested using Fisher exact test.
OUTCOME AND STUDY END POINT:
The study will involve both clinical and laboratory based work, and the outcomes are as follows.
- Laboratory based work: From each patient, 4 samples will be taken and hence 160 samples will be analysed. From each sample, the investigators will analyse the activation of pro-inflammatory cells (polymorphs, macrophages), level of messenger RNA. The investigators will analyse level of (pro)inflammatory cytokines-- IL1,2,6,9,10, and TNF. The investigators will assess the relationship between time (duration of operation) and the inflammatory markers. The study will aim to prove that prove that as duration of operation increase, the extent of in inflammation the intestine's surface increases, and that this process can be mitigated by using humidified warmed carbon dioxide gas.
- Clinical based work:
The study will see whether use of humidified, warmed carbon dioxide gas results in:
- Better core body temperature control
- Less postoperative pain
- Shorter hospital stay
- Less risk of complications, including wound infection, anastomotic leaks.
- Conditions
- Peritoneal Inflammation, Peritoneum; Injury
- Being tested
- Humidified, warmed CO2 insufflation of open peritoneum using Fisher & Paykel's HUMIGARD (Fisher & Paykel Healthcare Ltd, Auckland, New Zealand), Standard heating
- Medical subject headings
- Peritonitis, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humidified, warmed CO2 insufflation of open peritoneum using Fisher & Paykel's HUMIGARD (Fisher & Paykel Healthcare Ltd, Auckland, New Zealand)Device
The study group will receive warmed (37°C), humidified (98% RH) carbon dioxide into the open peritoneal cavity using the Fisher \& Paykel's HUMIGARD system (Fisher \& Paykel Healthcare Ltd, Auckland, New Zealand). This will create a local atmosphere of 100% carbon dioxide (warmed, humidified) in the open peritoneal cavity.
Standard heatingDevice
Standard intraoperative warming measures including heated blankets, heating with forced warmed air, warming of fluids, and insulation of limbs and head
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Standard intraoperative warming measures including heated blankets, heating with forced warmed air, warming of fluids, and insulation of limbs and head. Receives: Device: Standard heating |
| Study Group | Experimental | The study group will receive warmed (37°C), humidified (98% RH) carbon dioxide delivered into the open peritoneal cavity. Receives: Device: Humidified, warmed CO2 insufflation of open peritoneum using Fisher & Paykel's HUMIGARD (Fisher & Paykel Healthcare Ltd, Auckland, New Zealand) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Inflammatory cytokine level in the peritoneal biopsy samples
Peritoneal samples will be taken when the peritoneal cavity is being opened (at beginning of operation), and also when the peritoneal cavity is being closed (at end of the operation). The change in the level of inflammatory cytokines in between these two time points will be measured
Measured: At the moment of time when: (1) peritoneal cavity is being opened, (2) when peritoneal cavity is being closed (expected average of 2 hours after peritoneal cavity is first opened)
Intraoperative temperature at 30 minutes from start of operation
Temperature readings during the operation will be taken. Both core body temperature (esophageal) and intraperitoneal temperature will be measured.
Measured: 30 minutes from start of operation
Intraoperative temperature at 60 minutes from start of operation
Temperature readings during the operation will be taken. Both core body temperature (esophageal) and intraperitoneal temperature will be measured.
Measured: 60 minutes from start of operation
Secondary outcomes (3)
Postoperative Analgesia requirement for pain
Postoperative pain as measured by MEDD (Morphine Equivalent Daily Dose)
Measured: Time from when the patient is moved out of operating theater to when the patient is no longer an inpatient in the hospital ward (discharged), with an expected average of 1 week
Length of in-patient hospital stay
number of days patient stayed postoperatively in hospital
Measured: duration of hospital stay, an expected average of 1 week
Anastomotic leaks
The occurrence of anastomotic leak in the 6 months after the surgery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startAug 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Peritoneal InflammationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concord Repatriation General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Ju Yong Cheong, Concord Repatriation General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975947
- Sponsor's protocol ID
- HREC/12/CRGH/196
- Status last verified
- Nov 2016
- First submitted
- 2 Nov 2016
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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 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, 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, 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, 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 15108726Svenarud 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 12771877Svenarud 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 12538172Hannenberg AA, Sessler DI. Improving perioperative temperature management. Anesth Analg. 2008 Nov;107(5):1454-7. doi: 10.1213/ane.0b013e318181f6f2. No abstract available.
PubMed 18931198Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76.
PubMed 18648241Insler 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 17342966Sessler 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 16927930Binda MM, Koninckx PR. Prevention of adhesion formation in a laparoscopic mouse model should combine local treatment with peritoneal cavity conditioning. Hum Reprod. 2009 Jun;24(6):1473-9. doi: 10.1093/humrep/dep053. Epub 2009 Mar 3.
PubMed 19258346Tsuchiya M, Sato EF, Inoue M, Asada A. Open abdominal surgery increases intraoperative oxidative stress: can it be prevented? Anesth Analg. 2008 Dec;107(6):1946-52. doi: 10.1213/ane.0b013e318187c96b.
PubMed 19020142Peng Y, Zheng M, Ye Q, Chen X, Yu B, Liu B. Heated and humidified CO2 prevents hypothermia, peritoneal injury, and intra-abdominal adhesions during prolonged laparoscopic insufflations. J Surg Res. 2009 Jan;151(1):40-7. doi: 10.1016/j.jss.2008.03.039. Epub 2008 Apr 23.
PubMed 18639246Brokelman WJ, Holmdahl L, Bergstrom M, Falk P, Klinkenbijl JH, Reijnen MM. Heating of carbon dioxide during insufflation alters the peritoneal fibrinolytic response to laparoscopic surgery : A clinical trial. Surg Endosc. 2008 May;22(5):1232-6. doi: 10.1007/s00464-007-9597-x. Epub 2007 Oct 18.
PubMed 17943363
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Humidified CO2 Insufflation in Open Laparotomy Colorectal Surgery Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02975947
- Acronym / sponsor ID
- HREC/12/CRGH/196
- Conditions
- Peritoneal Inflammation, Peritoneum; Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Concord Repatriation General HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 29 Nov 2016 (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.
The operating theatre is deliberately made to be cold and dry to prevent bacteria from growing. The problem with this is that during open abdominal surgery, the intestine and the overlying peritoneum is exposed to cold dry air. Surgeons try to stop the bowel/peritoneum from drying by applying warmed saline packs periodically to the bowel. However, this is not always possible. Sometimes, the surgeon has to perform an important component of the procedure (attach bowel/blood vessels together etc) and the bowel/peritoneum visibly dries. When bowel/peritoneum dries damage occurs, inducing inflammation. Inflamed bowel/peritoneum causes the bowel to stick together and form adhesions. Bowel adhesions can cause bowel obstruction. This vicious cycle is repeated when the patient undergoes repetitive open abdominal operations.
This study aimed to be the first human study to:
- Demonstrate that peritoneal inflammation occurs during open abdominal surgery and also to demonstrate that pro-inflammatory cells (polymorphs, macrophages) are activated during the progress of the operation. This study aims to show that mRNA(using Q-PCR) is increased for pro-inflammatory cytokines. This study also aim to show that proinflammatory cytokines (Interleukin(IL)-1,2,6,9,10, and TNF by ELISA/confirmed using Western Blotting) are elevated during the course of the operation.
- Demonstrate that the mechanism of bowel/peritoneal inflammation is causally related to the bowel/peritoneum drying (dessication).
This study will attempt to prove this by using humidified, warmed carbon dioxide gas which will warm and moisten the peritoneum/bowel. It is proposed that this will arrest the peritoneal injury and the inflammation. The investigators will attain peritoneal samples during open colorectal operations. The investigators will obtain samples at the beginning and end of the operation. This study design is a randomized controlled trial, where half the patients will receive humidified, warmed carbon dioxide gas during surgery, and the other half will get standard open surgery without carbon dioxide. 40 patients will be recruited in this study. Half (20) will get CO2, and other half (20) will get standard open surgery.
Detailed description
Forty patients undergoing open colorectal surgery will be recruited in this randomized controlled trial.
The study group will receive warmed (37°C), humidified (98% RH) carbon dioxide. The delivered gas will be defined by the United States Pharmacopeia and National Formulary, which requires impurity of less than 200 parts per million, including water vapour. This medical grade CO2 will be warmed to 37°C and humidified to 98% RH using humidification system. The sterility of the system will be assessed regularly as per protocol.
The control group will receive no gas insufflation into the open laparotomy wound. This is current standard practice for all patients undergoing open laparotomy for colorectal resection.
The device that will be used for insufflation of sterile, humidified, warmed CO2 is the Fisher \& Paykel's HUMIGARD (Fisher \& Paykel Healthcare Ltd, Auckland, New Zealand).
It consists of a bacterial filter and a humidification chamber filed with 180mL sterile water, positioned on a humidifier controller that includes an integrated temperature and flow sensor. The outlet of the humidification chamber is connected to a thermally insulated 2.5m-long heated insufflation tube that maintains temperature and humidity of the gas to its outlet. The warm and humidified CO2 enters a gas diffuser (ST300DF VITA-diffuserTM, Cardia Innovation AB, Stockholm, Sweden) consisting of a 25cm-long polyvinylchloride tube (inner diameter of 2.5mm) with polyurethane foam at its end. The cylindrical polyurethane foam tip diverts the gas jet in multiple directions via the many small paths inside the foam. The gas is thus uniformly distributed and the large diffuser surface area greatly reduces the velocity of the outflow. Thus the system delivers humidified CO2 at 100% relative humidity and 37C to the surgical wound. The gas diffuser will be positioned inside the open abdominal wound cavity (in the right cranial quadrant) at a depth of approximately 4cm from the skin as soon as the abdominal wall retraction has been done. The insufflation of warm humidified CO2 will then start and continue until the abdominal wall retractors are removed and abdominal wall is commenced to be closed.
Calculation of Power: The investigators estimated sample size of 40 patients for 80% power using the literatures' reported standard deviation of levels of 3-chlorotyrosine (which is one of the study's primary biochemical markers of inflammation)
ANALYSIS OF BIOCHEMICAL AND MOLECULAR MARKERS: Where acquired, samples of the human tissue obtained (above) will be homogenised and assigned to biochemistry and molecular analyses. Total RNA will be extracted using a commercial kit, converted to cloned DNA and then probed for various pro-inflammatory genes. Where a change in gene regulation is noted, the investigators will assess the corresponding change in protein level using a combined approach consisting of multiplex ELISA to quantify changes in protein levels and further confirmation with Western blotting using corresponding specific antibodies.
STATISTICAL ANALYSIS: Statistical analysis will be performed using SPSS for Windows version 18.0 GradPack (IBM, New York, USA). Non-parametric continuous variables will be tested using Mann-Whitney U tests and parametric continuous variable will be tested using t-test/ANOVA. Categorical variables will be tested using Fisher exact test.
OUTCOME AND STUDY END POINT:
The study will involve both clinical and laboratory based work, and the outcomes are as follows.
- Laboratory based work: From each patient, 4 samples will be taken and hence 160 samples will be analysed. From each sample, the investigators will analyse the activation of pro-inflammatory cells (polymorphs, macrophages), level of messenger RNA. The investigators will analyse level of (pro)inflammatory cytokines-- IL1,2,6,9,10, and TNF. The investigators will assess the relationship between time (duration of operation) and the inflammatory markers. The study will aim to prove that prove that as duration of operation increase, the extent of in inflammation the intestine's surface increases, and that this process can be mitigated by using humidified warmed carbon dioxide gas.
- Clinical based work:
The study will see whether use of humidified, warmed carbon dioxide gas results in:
- Better core body temperature control
- Less postoperative pain
- Shorter hospital stay
- Less risk of complications, including wound infection, anastomotic leaks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Device: Standard heatingStandard intraoperative warming measures including heated blankets, heating with forced warmed air, warming of fluids, and insulation of limbs and head. |
| Study Group | Experimental | Device: Humidified, warmed CO2 insufflation of open peritoneum using Fisher & Paykel's HUMIGARD (Fisher & Paykel Healthcare Ltd, Auckland, New Zealand)The study group will receive warmed (37°C), humidified (98% RH) carbon dioxide delivered into the open peritoneal cavity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults above age 18.
- Elective patients.
- Pathologies: colorectal carcinoma, polyposis syndromes, diverticular diseases, prolapses, and patients with inflammatory bowel disease undergoing elective resection.
- For colorectal carcinoma, all patients whether they are having curative or palliative surgery will be included.
- Patients undergoing open elective colectomy, with or without stoma formation/ bowel anastomosis.
Key exclusion criteria (3 listed)
- Patients undergoing acute surgery (emergency surgery).
- Patients undergoing Laparoscopic colectomy (multiport, single incision and also hand assisted) as all these patients receive heated humidified CO2.
- For COPD patients, the exclusion criteria would be patients: (1) On home oxygen, (2) Type 2 respiratory failure (CO2 retainers) (3) FEV1<1L, or FEV1/FVC <50% of predicted
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 CO2 insufflation of open peritoneum using Fisher & Paykel's HUMIGARD (Fisher & Paykel Healthcare Ltd, Auckland, New Zealand)The study group will receive warmed (37°C), humidified (98% RH) carbon dioxide into the open peritoneal cavity using the Fisher \& Paykel's HUMIGARD system (Fisher \& Paykel Healthcare Ltd, Auckland, New Zealand). This will create a local atmosphere of 100% carbon dioxide (warmed, humidified) in the open peritoneal cavity. | Device | Study Group |
| Standard heatingStandard intraoperative warming measures including heated blankets, heating with forced warmed air, warming of fluids, and insulation of limbs and head | Device | Control Group |
Primary outcome
Change in Inflammatory cytokine level in the peritoneal biopsy samples
Time frame: At the moment of time when: (1) peritoneal cavity is being opened, (2) when peritoneal cavity is being closed (expected average of 2 hours after peritoneal cavity is first opened)
Peritoneal samples will be taken when the peritoneal cavity is being opened (at beginning of operation), and also when the peritoneal cavity is being closed (at end of the operation). The change in the level of inflammatory cytokines in between these two time points will be measured
Intraoperative temperature at 30 minutes from start of operation
Time frame: 30 minutes from start of operation
Temperature readings during the operation will be taken. Both core body temperature (esophageal) and intraperitoneal temperature will be measured.
Intraoperative temperature at 60 minutes from start of operation
Time frame: 60 minutes from start of operation
Temperature readings during the operation will be taken. Both core body temperature (esophageal) and intraperitoneal temperature will be measured.
3 secondary outcomes
Postoperative Analgesia requirement for pain
Time frame: Time from when the patient is moved out of operating theater to when the patient is no longer an inpatient in the hospital ward (discharged), with an expected average of 1 week
Length of in-patient hospital stay
Time frame: duration of hospital stay, an expected average of 1 week
Anastomotic leaks
Time frame: 6 months
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 29 Nov 2016.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 15108726Persson 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.
- Results publication: PubMed 12771877Svenarud 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.
- Results publication: PubMed 12538172Svenarud 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.
- Results publication: PubMed 18931198Hannenberg AA, Sessler DI. Improving perioperative temperature management. Anesth Analg. 2008 Nov;107(5):1454-7. doi: 10.1213/ane.0b013e318181f6f2. No abstract available.
- Results publication: PubMed 18648241Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76.
- Results publication: PubMed 17342966Insler SR, Sessler DI. Perioperative thermoregulation and temperature monitoring. Anesthesiol Clin. 2006 Dec;24(4):823-37. doi: 10.1016/j.atc.2006.09.001.
- Results publication: PubMed 16927930Sessler DI. Non-pharmacologic prevention of surgical wound infection. Anesthesiol Clin. 2006 Jun;24(2):279-97. doi: 10.1016/j.atc.2006.01.005.
- Results publication: PubMed 19258346Binda MM, Koninckx PR. Prevention of adhesion formation in a laparoscopic mouse model should combine local treatment with peritoneal cavity conditioning. Hum Reprod. 2009 Jun;24(6):1473-9. doi: 10.1093/humrep/dep053. Epub 2009 Mar 3.
- Individual participant dataSharing planned: No
Related trials for Peritoneal Inflammation
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis
Complicated Diverticulitis, Acute Diverticulitis
RecruitingPhase 1/2
Nitazoxanide in Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
RecruitingPhase 1/2
N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
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.
The record lists no contact. Use the official record to reach the sponsor.
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 insufflation of open peritoneum using Fisher & Paykel's HUMIGARD (Fisher & Paykel Healthcare Ltd, Auckland, New Zealand) and Standard heating in people with Peritoneal Inflammation and Peritoneum; Injury, run by Concord Repatriation General Hospital at 1 site in Australia.
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 5 inclusion and 3 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 29 Nov 2016. 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 Australia. 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?
Change in Inflammatory cytokine level in the peritoneal biopsy samples (time frame: At the moment of time when: (1) peritoneal cavity is being opened, (2) when peritoneal cavity is being closed (expected average of 2 hours after peritoneal cavity is first opened)). The study lists 3 primary outcomes in all. 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 NCT02975947, which also lists 24 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 29 Nov 2016.