atrial fibrillation
Conditions
Interventions
"Spacemaker" facilitated thoracoscopy
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Age * 18 * 70 years * Dutch speaking * Patients undergoing thoracoscopic atrial fibrillation surgery * Informed consent
Exclusion criteria
Exclusion criteria: * Significant cardiac or respiratory comorbidity as assessed by cardiologist or anesthesiologist * History of tuberculosis (TBC) or pleuritis * Prior thoracic trauma * Prior thoracic surgery * Known allergy for poly urethanes of polyvinyl chloride
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) The feasibility to introduce a soft tissue expander trough a mini-thoracotomy. 2) The feasibility to inflate and position the soft tissue expander in the human hemithorax. 3) The feasibility to create a trans-soft tissue expander approach to the human pericardium and to quantitatively assess the working space on the pericardium. | — |
Secondary
| Measure | Time frame |
|---|---|
| * The hemodynamic response after implantation and optimal positioning of the soft tissue expander. o Change in heartrate o Change in CVP o Change in right ventricular pressure o Change in PAP o Change in CI o Change in Arterial blood pressure * The ventilatory response after implantation and optimal positioning of the soft tissue expander while maintaining similar tidal volumes and ventilation frequencies. o Change in pulmonary airway pressure (maximum and mean) o Change in carbondioxide end-tidal-pressure o Change in lung compliance * The respiratory response after implantation and optimal positioning of the soft tissue expander. o Change in arterial blood oxygenation o Change in arterial blood pCO2 and pO2 * Evaluating whether the optimal length size as obtained on CT-scan corresponds with the ideal length size in humans. o The occurrence of possible complications due to tissue expander implantation. o The occurrence of arrhytmias due to tissue expander implantation. o The occurrence of atelectasis and the insufflation pressure necessary to re-expand the collapsed lung after removal of the soft tissue expander. | — |
Countries
Netherlands
Outcome results
None listed