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Intraoperative Wound Ventilation with Carbon Dioxide.


- candidate number1921
- NTR NumberNTR561
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-jan-2006
- Secondary IDsN/A 
- Public TitleIntraoperative Wound Ventilation with Carbon Dioxide.
- Scientific TitleDoes Intraoperative Wound Ventilation with Carbon Dioxide (CO2) Reduce Cerebral Micro-embolisation and Alters Neurologic Outcome in Aortic Arch Surgery: a Prospective Randomised Study Using Transcranial Doppler Monitoring, Neuropsychometric study and Diffusion-weighted MR-imaging.
- ACRONYMN/A
- hypothesisWe hypothesize that the use of Carbon Dioxide (CO2) reduces the incidence of (air) microembolism during aortic arch surgery, and that it also positively influences the gross neurologic and/or the neurocognitive outcome of this kind of surgery.
- Healt Condition(s) or Problem(s) studiedAortic arch surgery
- Inclusion criteriaPatients accepted for elective aortic arch surgery (with or without concomitant surgery on the ascending aorta or other heart related surgery).
- Exclusion criteria1. Emergency operation;
2. Severely calcified or sclerotic aorta or cerebropetal vessels;
3. Patients with history of central neurological events (minor or major strokes);
4. Patients with signs of infarcts on preoperative MR-imaging;
5. Patients with pre-existing atrial fibrillation;
6. Patients that are unable to cooperate or score poorly on preoperative neurocognitive testing;
7. Patients with history of alcohol disuse;
8. Patients with history of psychiatric disturbances.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 30-jan-2006
- planned closingdate30-jan-2007
- Target number of participants60
- InterventionsPatients will be randomized to receive peroperative carbondioxide wound ventilation or not. In one group peroperative carbon dioxide insufflation of the wound will be combined with conventional de-airing procedures at the end of the operation; in a second group only conventional de-airing procedures will be done.
- Primary outcomeLess microembolism assessed by Trans-Cranial Doppler (TCD) monitoring of the left and right middle cerebral artery.
- Secondary outcomeNeurological outcome assessed by clinical neurological testing and neurocognitive outcome assessed by comprehensive neuropsychometric studies (intelligence, problem-solving, concentration, learning, memory, error-free performance, mood abnormalities, and dexterity are components of the general neuropsychological system, and all of these have been included in the term cognitive functions). These testings are performed the day before surgery, the day before hospital discharge and 3 months postoperatively.
Morphologic alterations of the brain are searched for by comparing preoperative and postoperative diffusion-weighted MR-imaging scans of the brain.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. S.R.E. Laga
- CONTACT for SCIENTIFIC QUERIESMD. S.R.E. Laga
- Sponsor/Initiator St.-Antonius Hospital, Departement of Cardio-thoracic Surgery
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryThe relationship between cerebral air microembolisms in open heart surgery and neurologic outcome remains unclear. It is also still questionable if the risk of air microembolism can be reduced by intraoperative wound ventilation by CO2 insufflation. Therefore, we will study the effect of CO2 insufflation into the sternal wound on the incidence of intraoperative cerebral microembolism and postoperative neurocognitive deficits (temporary neurological deficiency) and minor or major stroke. Morphological differences (between preoperative and postoperative imaging of the brain) will be searched for by diffusion-weighted MR-imaging.
- Main changes (audit trail)
- RECORD11-jan-2006 - 16-nov-2009


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