None listed
Conditions
Brief summary
Hypothesis : Angiogenesis depends on adequate oxygenation and is enhanced by high PtO2 Aims Maintanence of adequate tissue perfusion and oxygenation in patients undergoing open abdominal surgery To quantify the effect on tissue oxygenation, of insufflation of warm-humidified CO2 into the abdominal cavity during open abdominal surgery in humans. The primary endpoint for this trial is tissue oxygen partial pressure. Secondary endpoints are arterial oxygen partial pressure (PaO2), arterial carbon dioxide partial pressure (PaCO2), arterial haemoglobin oxygen saturation and core body temperature.
Interventions
The purpose of the research is to investigate whether insufflation of warm, humidified carbon dioxide into the open abdominal cavity during open abdominal surgery can increase sub-peritoneal tissue oxygen partial pressure. The amount of oxygen is an important indicator of tissues’ ability to resist infection and possibly post-operative adhesions.
The CO2 insufflation gas will be warmed to approximately 37 degrees C, humidified to > 90 % relative humidity and delivered to the surgical field usin
The purpose of the research is to investigate whether insufflation of warm, humidified carbon dioxide into the open abdominal cavity during open abdominal surgery can increase sub-peritoneal tissue oxygen partial pressure. The amount of oxygen is an important indicator of tissues’ ability to resist infection and possibly post-operative adhesions. The CO2 insufflation gas will be warmed to approximately 37 degrees C, humidified to > 90 % relative humidity and delivered to the surgical field using a humidifier and heated tube (Surgical Humidification System, Fisher & Paykel Healthcare, Auckland, New Zealand) The gas will pass through a diffuser (VitaDiffuser, Cardia Innovation AB, Stockholm, Sweden) placed at the edge of the surgical wound, approximately 2 cm within the peritoneal cavity. The gas flow rate will be 10 L/min, as this has been shown to be the flow rate necessary to main a CO2 surgical microclimate despite the use of suction and movement of hands and instruments within the surgical cavity Following stabilisation of the oxygen partial pressure probe (30 minutes as per manufacturers instruction), the subject will be randomized to recieve either heated humidifed gas on or gas off (standard care) for 30 minute intervals, at the end of the 30 minute interval the alternative treatment will be applied and so on and so forth until the end of the procedure. . If the surgery is completed before the end of a 30 minute interval, data recorded during that interval will be excluded from the analysis. During the trial all surgeries and the placements of the device and probe will be performed by surgeon Ai Ling Tan.
Sponsors
Auckland District Health Board
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Scheduled to undergo an elective open abdominal surgical procedure with an intra-abdominal component. For gynaecological surgeries, surgery is expected to last >1 hour. Standard midline wound incision which is atl east 2cm deep so that the wounds are standardised. No additional incisions required for the trial. 18 years old Maximum eligible age of 80years. BMI <35
Exclusion criteria
Inability to give informed consent Already participated in this trial Pregnant Received radiotherapy to the incision site in the last 4 weeks Has an infection at the time of surgery at the site of incision After opening of the abdominal wall, surgeon determines that an appropriate intra-abdominal site for insertion of the oxygen probe does not exist. A likely cause may be diffuse peritoneal adhesions. A medical condition that affects haemoglobin saturation or will have a direct impact on perfusion, including severe lung disease. 1 hour time criterion only apply to gynaecological surgeries The trial will be taking place in the gynaeoncology department.
Outcome results
None listed