Rationale and design of PASSAT - patients' satisfaction with local or general anaesthesia in video-assisted thoracoscopic surgery: study protocol for a randomised controlled trial with a non-randomised side arm

• Published in: Current controlled trials in cardiovascular medicine Vol. 20; no. 1; p. 149
• Main Authors: Galetin, Thomas, Bretzke, Pascal, Lopez-Pastorini, Alberto, Schieren, Mark, Koryllos, Aris, Kosse, Nils, Schnell, Jost, Defosse, Jerome M, Wappler, Frank, Stoelben, Erich
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 27-02-2019; BioMed Central; BMC
• Subjects: Airway management; Analysis; Anesthesia; Biopsy; Carbon dioxide; Chronic obstructive pulmonary disease; Clinical trials; Confidentiality; General anaesthesia; General anesthesia; Local anaesthesia; Local anesthesia; Lymphatic system; Medical research; Patient satisfaction; Patients’ satisfaction; Psychometrically validated questionnaire; Questionnaires; Software; Study Protocol; Thoracic surgery; VATS; General anaesthesia; Psychometrically validated questionnaire; Thoracic surgery; VATS; Cost effectiveness; Local anaesthesia; Patients’ satisfaction
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-019-3190-1

Although general anaesthesia (GA) with one-lung ventilation is the current standard of care, minor thoracoscopic surgery, i.e. treatment of pleural effusions, biopsies and small peripheral pulmonary wedge resections, can also be performed using local anaesthesia (LA), analgosedation and spontaneous breathing. Whilst the feasibility and safety of LA have been demonstrated, its impact on patient satisfaction remains unclear. Most studies evaluating patient satisfaction lack control groups or do not meet psychometric criteria. We report the design of the PASSAT trial (PAtientS' SATisfaction in thoracic surgery - general vs. local anaesthesia), a randomised controlled trial with a non-randomised side arm.
Patients presenting for minor thoracoscopic surgery and physical eligibility for GA and LA are randomised to surgery under GA (control group) or LA (intervention group). Those who refuse to be randomised are asked to attend the study on the basis of their own choice of anaesthesia (preference arm) and will be analysed separately. The primary endpoint is patient satisfaction according to a psychometrically validated questionnaire; secondary endpoints are complication rates, capnometry, actual costs and cost effectiveness. The study ends after inclusion of 54 patients in each of the two randomised study groups.
The PASSAT study is the first randomised controlled trial to systematically assess patients' satisfaction depending on LA or GA. The study follows an interdisciplinary approach, and its results may also be applicable to other surgical disciplines. It is also the first cost study based on randomised samples. Comparison of the randomised and the non-randomised groups may contribute to satisfaction research.
German Clinical Trials Register, DRKS00013661 . Registered on 23 March 2018.