Patients' satisfaction with local and general anaesthesia for video-assisted thoracoscopic surgery-results of the first randomized controlled trial PASSAT.

OBJECTIVES: The objective of this single-centre, open, randomized control trial was to compare the patients' satisfaction with local anaesthesia (LA) or general anaesthesia (GA) for video-assisted thoracoscopy. METHODS: Patients with indication for video-assisted thoracoscopy pleural management, mediastinal biopsies or lung wedge resections were randomized for LA or GA. LA was administered along with no or mild sedation and no airway devices maintaining spontaneous breathing, and GA was administered along with double-lumen tube and one-lung ventilation. The primary end point was anaesthesia-related satisfaction according to psychometrically validated questionnaires. Patients not willing to be randomized could attend based on their desired anaesthesia, forming the preference arm. RESULTS: Fifty patients were allocated to LA and 57 patients to GA. Age, smoking habits and lung function were similarly distributed in both groups. There was no significant difference between the 2 groups with regard to patient satisfaction with anaesthesiology care (median 2.75 vs 2.75, P = 0.74), general perioperative care (2.50 vs 2.50, P = 0.57), recovery after surgery (2.00 vs 2.00, P = 0.16, 3-point Likert scales). Surgeons and anaesthesiologists alike were less satisfied with feasibility (P < 0.01 each) with patients in the LA group. Operation time, postoperative pain scales, delirium and complication rate were similar in both groups. LA patients had a significantly shorter stay in hospital (mean 3.9 vs 6.0 days, P < 0.01). Of 18 patients in the preference arm, 17 chose LA, resulting in similar satisfaction. CONCLUSIONS: Patients were equally satisfied with both types of anaesthesia, regardless of whether the type of anaesthesia was randomized or deliberately chosen. LA is as safe as GA but correlated with shorter length of stay. Almost all patients of the preference arm chose LA. Considering the benefits of LA, it should be offered to patients as an equivalent alternative to GA whenever medically appropriate and feasible.

Hypercapnia in COPD Patients Undergoing Endobronchial Ultrasound under Local Anaesthesia and Analgosedation: A Prospective Controlled Study Using Continuous Transcutaneous Capnometry.

BACKGROUND: Flexible bronchoscopy (FB) in analgosedation causes alveolar hypoventilation and hypercapnia, the more so if patients suffer from COPD. Nonetheless, neither is capnometry part of standard monitoring nor is there evidence on how long patients should be monitored after sedation. OBJECTIVES: We investigated the impact of COPD on hypercapnia during FB with endobronchial ultrasound (EBUS) in sedation and how the periprocedural monitoring should be adapted. METHODS: Two cohorts of consecutive patients - with advanced and without COPD - with the indication for FB with EBUS-guided transbronchial needle aspiration in analgosedation received continuous transcutaneous capnometry (ptcCO2) before, during, and for 60 min after the sedation with midazolam and alfentanil. MAIN RESULTS: Forty-six patients with advanced COPD and 44 without COPD were included. The mean examination time was 26 ± 9 min. Patients with advanced COPD had a higher peak ptcCO2 (53.7 ± 7.1 vs. 46.8 ± 4.8 mm Hg, p < 0.001) and mean ptcCO2 (49.5 ± 6.8 vs. 44.0 ± 4.4 mm Hg, p < 0.001). Thirty-six percent of all patients reached the maximum hypercapnia after FB in the recovery room (8 ± 11 min). Patients with COPD needed more time to recover to normocapnia (22 ± 24 vs. 7 ± 11 min, p < 0.001). They needed a nasopharyngeal tube more often (28 vs. 11%, p < 0.001). All patients recovered from hypercapnia within 60 min after FB. No intermittent ventilation manoeuvres were needed. CONCLUSION: A relevant proportion of patients reached their peak-pCO2 after the end of intervention. We recommend using capnometry at least for patients with known COPD. Flexible EBUS in analgosedation can be safely performed in patients with advanced COPD. For patients with advanced COPD, a postprocedural observation time of 60 min was sufficient.

[Video-assisted Thoracoscopic Surgery in Local Anaesthesia and Analgosedation - a Survey of the Members of the German Society of Thoracic Surgeons]. / Videoassistierte thorakoskopische Chirurgie in Lokalanästhesie und Analgosedierung ­ eine Umfrage unter den Mitgliedern der Deutschen Gesellschaft für Thoraxchirurgie.

INTRODUCTION: There is increasing international interest in the use of video-assisted thoracoscopic procedures (VATS) with spontaneous respiration in the treatment of elderly and multimorbid patients. Data on the application and acceptance in Germany are not yet available. METHOD: Germany-wide, online-based survey among the departments of thoracic surgery registered at the German Society of Thoracic Surgeons (DGT) on the application of VATS in local anaesthesia (LA). RESULTS: 101 of 157 hospitals responded (64%). 42% of the respondents perform non-intubated VATS (NIVATS), 31% VATS in LA. Reasons not to perform VATS in LA are lack of experience (51%), doubts about feasibility (29%) and missing indications (24%). Among the performing clinics, the most frequent procedures are pleural catheterisation (94%), pleural biopsy (87%) and pleurodesis (87%). 42% of the clinics perform wedge resections and 10% also anatomical resections in LA. Main target groups are multimorbid patients (77%), elderly patients (65%), patients with anxiety about general anaesthesia (55%) and patients with pre-existing lung diseases (52%). In 97% of the departments, sedation is performed by anaesthesiologists. The main technical difficulties mentioned are impaired view of the surgical field (39%), hypercapnia (29%) and panic attacks (23%). Pain is of minor importance (3%). DISCUSSION: About one third of the participating departments already perform VATS in LA; others have plans to introduce the method. The majority of respondents regard multimorbid, elderly and lung patients as the main target groups, as fewer inflammatory, respiratory and neurological complications are expected.

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.

BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00013661 . Registered on 23 March 2018.