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Intraoperative Wound Ventilation with Carbon Dioxide.

Does 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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24534
Enrollment
60
Registered
2006-01-11
Start date
2006-01-30
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic arch surgery.

Interventions

in a second group only conventional de-airing procedures will be done.
Patients 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-air

Sponsors

St.-Antonius Ziekenhuis, Nieuwegein departement of Cardio-thoracic Surgery
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients accepted for elective aortic arch surgery (with or without concomitant surgery on the ascending aorta or other heart related surgery).

Exclusion criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

MeasureTime frame
Less microembolism assessed by Trans-Cranial Doppler (TCD) monitoring of the left and right middle cerebral artery.

Secondary

MeasureTime frame
Neurological 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.

Contacts

Public ContactS.R.E. Laga

St.-Antonius Hospital, Departement of Cardio-thoracic Surgery, P.O. Box 2500

steven_laga@yahoo.com

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)