Thopaz ™ Current Research Findings PROVIDING ADVANCED TREATMENT WITH EASE Precious life – Progressive care Thoracic Drainage System Index Multicenter International Randomized Comparison of Objective and Subjective Outcomes Between Electronic and Traditional Chest Drainage Systems........................... C. Pompili, F. Detterbeck, K. Papagiannopoulos, A. Sihoe, K. Vachlas, M. W. Maxfield, H. C. Lim, A. Brunelli. The Annals of Thoracic Surgery. (2014) 98: 490–497. Page 4 Does External Pleural Suction Reduce Prolonged Air Leak After Lung Resection? Results from the AirINTrial After 500 Randomized Cases................................................... 7 F. Leo, L. Duranti, L. Girelli, S. Furia, A. Billè, G. Garofalo, P. Scanagatta, R. Giovannetti, U. Pastorino Annals of Thoracic Surgery. (2013). 96:1234–1239. Regulated tailored suction vs regulated seal: A prospective randomized trial on air leak duration.............................................................................................................. 9 A. Brunelli, M. Salai, C. Pompili, M. Refai, A. Sabbatini European Journal of Cardio-Thoracic Surgery 0 (2012) 1–6. Impact of the learning curve in the use of a novel electronic chest drainage system after pulmonary lobectomy: a case-matched analysis on the duration of chest tube usage.............................................................................................................. 11 C. Pompili, A. Brunelli, M. Salati, M. Refai, A. Sabbatini Interactive Cardiovascular & Thoracic Surgery. (2011). 13:490–493. Open access article available online. Thopaz Portable Suction Systems in Thoracic Surgery: An end user assessment and feedback in a tertiary unit..................................................... 13 S. Rathinam, A. Bradley, T. Cantlin, P. B. Rajesh Journal of Cardiothoracic Surgery. (2011) 6:59. Open access article available online. The benefits of digital air leak assessment after pulmonary resection: Prospective and comparative study................................................................... 15 J. M. Mier, L. Molins, J. J. Fibla Cirugía Española. (2010). 87(6):385–389 Postoperative chest tube management: measuring air leak using an electronic device decreases variability in the clinical practice............................................................ 17 G. Varela, M. F. Jimenez, N. M. Novoa, J. L. Aranda European Journal of Cardio-thoracic Surgery. (2009). 35:28–31 The quantification of postoperative air leak........................................................................ 19 Cerfolio R. J., Bryant A. S. (2009) Multimedia Manual of Cardiothoracic Surgery. DOI:10.1510/mmcts.2007.003129. Multicenter International Randomized Comparison of Objective and Subjective Outcomes Between Electronic and Traditional Chest Drainage Systems 4 C. Pompili, F. Detterbeck, K. Papagiannopoulos, A. Sihoe, K. Vachlas, M. W. Maxfield, H. C. Lim, A. Brunelli. The Annals of Thoracic Surgery. (2014) 98: 490–497 Study Background & Design The aim of this study was to compare a digital (Thopaz) versus a traditional drainage system with patients who underwent pulmonary lobectomy or segmentectomy for the objective (duration of chest tube placement) and subjective (patient satisfaction) outcome at 4 international centers (United States, United Kingdom, Italy and Hong Kong). The study also explored whether differences in expectations or health care systems in the 4 regions of the world affected the observed differences between these groups. This study was conducted on patients randomized into two groups (191 digital; 190 traditional) who were well matched for baseline and surgical characteristics. The digital (Thopaz) group were placed on -20 cmH20 until the morning of postoperative day 1, and then physiological mode (-8 cmH2O) thereafter. Traditional devices were attached to wall suction (-20 cmH20) until the morning of postoperative day 1, and then transferred to water seal thereafter. On the digital system, chest tubes were removed when the air flow was lower than 30 ml/min for 8 hours without spikes of air leak, and on the traditional system when no detectable air leak was observed. Fluid criteria for drain removal ranged from 300–400 ml/day depending upon center. Patient satisfaction was assessed through a questionnaire as outlined in Table 1. Question 1: Do you feel that your chest drainage system prevents you from getting out of bed? 1. 2. 3. 4. 5. I cannot get out of bed. I can get out of bed infrequently or with great difficulty. I can get out of bed most of the time but with some limitations. I can get out of bed with minor inconvenience. I can get out of bed all the time. Question 2: Does your chest drainage system allow you to walk around the room or ward alone? 1. 2. 3. 4. 5. I cannot walk freely. I can walk freely infrequently or with great difficulty. I can walk freely most of the time but with some limitations. I can walk freely with minor inconvenience. I can walk freely all the time. Question 3: How convenient or inconvenient for the personnel or other patients do you think your chest drainage system is? 1. 2. 3. 4. 5. Very inconvenient Inconvenient Neither convenient or inconvenient Convenient Very convenient 1. Question 4: How easy to carry around would you consider your chest 2. 3. drainage system? 4. 5. Very difficult Difficult Neither easy or difficult Easy Very easy Question 5: How socially comfortable do you feel when walking in public areas with this device? 1. 2. 3. 4. 5. Very uncomfortable Uncomfortable Neither comfortable or uncomfortable Comfortable Very comfortable Question 7: How comfortable do you feel at night in your bed with your chest drainage system (moving in bed, changing position)? 1. 2. 3. 4. 5. Very uncomfortable Uncomfortable Neither comfortable or uncomfortable Comfortable Very comfortable Table 1: Questionnaire used to assess patient satisfaction of their chest drainage device using a 5-point Likert-type scale. Results The study shows that patients randomized to digital systems had a significantly shorter air leak duration, duration of chest tube placement and postoperative length of hospital stay (Figure 1) and that this was consistent across the 4 global centers (Figure 2). Importantly, patients on the digital system experienced a greater than 50% reduction in the duration of air leak (Figure 1). 6 5 5.6 4.7 4 3 4.6 3.6 2 Digital drainage device Traditional drainage device 2.2 1 0 1.0 Duration air leak (p=0.001) Duration chest tube placement (p=0.0001) Postoperative length of hospital stay (p <0.0001) Figure 1: Duration of air leak, chest tube placement and postoperative length of hospital stay (days). 5 6 5 6 4 3 5.8 5.8 5.4 4.9 4.6 4.9 4.9 3.8 2 Digital Traditional 1 0 US UK Italy HK Figure 2: Differences in length of postoperative stay (days) in different centers. (US=United States; UK=United Kingdom; HK=Hong Kong). Assessment of patient satisfaction of their chest drainage device showed that patients managed with digital device had a more positive perception of their chest drainage system, in particular related to its comfort, portability and convenience for personnel and patients compared with those managed with the traditional device. 4.0 3.5 3.9 3.7 3.0 3.3 2.5 3.5 3.1 3.3 3.6 3.5 3.2 3 3 2.8 2.0 1.5 Digital Traditional 1.0 0.5 0.0 Q1 Q2 Q3 Q4 Q5 Q7 Figure 3: Results of the comparison of patient satisfaction between the 2 groups. Higher scores reflect a more positive perception of the system. (Q=Question). Conclusions lPatients managed with Thopaz experienced a greater than 50% reduction in air leak duration, a shorter duration of chest tube drainage and 1 day reduction in hospital stay when compared with those managed with traditional devices. lSubjective outcomes showed higher satisfaction scores for Thopaz with improved ability of patients to arise from bed and a greater convenience for patients and personnel. l These findings appeared to be consistent across different health care systems and countries. Does External Pleural Suction Reduce Prolonged Air Leak After Lung Resection? Results from the AirINTrial After 500 Randomized Cases F. Leo, L. Duranti, L. Girelli, S. Furia, A. Billè, G. Garofalo, P. Scanagatta, R. Giovannetti, U. Pastorino. Annals of Thoracic Surgery. (2013). 96:1234–1239. Study Background & Design The aim of this study was to test the hypothesis if external suction may reduce the rate of prolonged air leak. Portable suction devices, such as Thopaz, became interesting as they record a large amount of data on airflow and intrapleural pressure, which have been suggested as being predictors of prolonged air leak. Furthermore, increased mobility due to portable suction may play a role in promoting lung healing. This study presents results of the first interim analysis after randomization of 500 cases, with 250 in each of the external suction and no external suction (control) groups. Results There was no significant difference (p>0.05) between the two groups in terms of demographic and clinical characteristics of the population after randomization. On postoperative day 7, the chest drain was still in place in 25 patients in the external suction group and in 34 patients in no external suction group. The difference between the two groups was significant (p<0.05) in favor of the external suction group and in those patients undergoing anatomical compared to non-anatomical resection. The results show that external s uction reduces the prolonged air leak rate in this subgroup of patients (Figure 1). There was no significant differences (p>0.05) observed between the two groups in any other post-operative outcomes. * 25 25 20 15 10 * 14 11 5 9 0 Anatomic Nonanatomic Figure 1: Number of patients with Prolonged Air Leak on POD7. Comparison between the external suction and no external suction (control) groups for both Anatomic and Nonanatomic resections. *(p<0.05) External suction No external suction 7 60 56 40 8 20 35 12 10 9 5 4 External suction No external suction 4 2 0 Pleural (p=0.01) Pneumothorax (p=0.04) Subcutaneous emphysema (p=0.16) 1 Empyema, without fistula (p=0.5) Figure 2: Number of patients with pleural complications. Conclusions l Routine use of external suction reduces the rate of prolonged air leak after anatomic lung resection. l Use of external suction reduces the rate of pleural complications, specifically pneumothoraces. Regulated tailored suction vs regulated seal: A prospective randomized trial on air leak duration A. Brunelli, M. Salai, C. Pompili, M. Refai, A. Sabbatini European Journal of Cardio-Thoracic Surgery 0 (2012) 1–6. 9 Study Background & Design This study was aimed to compare the air leak duration of two regulated chest tube modes following pulmonary lobectomy by using an electronic regulated suction system. 100 patients with consecutive pulmonary lobectomies performed for lung cancer were included in the trial, group 1 with regulated individualized suction mode (range: -11 to -20 cmH2O, according to lobectomy type; n=50) and group 2, with regulated seal mode (-2 cmH2O; n=50). The duration of air leak was the main endpoint calculated from the end of the operation to a value consistently below 20ml/min. Results The two groups were well matched for baseline and surgical characteristics with exception of more males and lower FEV1/FVC ratio in the regulated seal group. No crossovers occurred between groups. There was no significant d ifference (p>0.05) between right side of lobectomy, upper side of lobectomy, pleural adhesions, length of stapled parenchyma, pleural effusion in first 48h, and percentage of patients with an air leak at 5 or 7 days. 8 7 6 6.1 5 5.1 4 4.3 3 4.3 2 1 0 1.2 Regulated suction Regulated seal 0.9 Duration air leak (p=0.8) Chest tube duration (p=0.7) Length of hospital stay (p=0.3) Figure 1: Duration of air leak, chest tube duration and length of hospital stay (days). 10% 10% 10% 8% 8% 10 8% 6% 4% Air leak >5 days (%) (p=1) Air leak >7 days (%) (p=1) 2% 0% Regulated suction Regulated seal Figure 2: Percentage of patients with an air leak greater than 5 and 7 days. 500 400 447 483 300 200 Effusion in the first 48 h (p=0.6) 100 0 Group 1 Regulated suction (50) Group 2 Regulated seal (50) Figure 3: Amount (ml) of pleural effusion in the first 48 hours. Conclusions l Regulated seal mode has the same effect as the regulated suction in managing chest tubes following lobectomy. l The study demonstrates with objective data the non-superiority of regulated suction vs regulated seal and may assist in future studies on regulated pleural pressure. l The study confirms, under controlled conditions, previous observations about the substantial equivalence between suction and no suction. Impact of the learning curve in the use of a novel electronic chest drainage system after pulmonary lobectomy: a casematched analysis on the duration of chest tube usage. C. Pompili, A. Brunelli, M. Salati, M. Refai, A. Sabbatini. Interactive Cardiovascular & Thoracic Surgery. (2011). 13:490-493. Open access article available online. Study Background & Design This study aimed to determine the duration of learning Thopaz, when first introduced into a clinical environment, and the impact it has on chest tube duration, length of stay and hospital costs. Using propensity score case-matched analysis, the first consecutive 51 lobectomy patients managed with Thopaz were compared to 51 controls managed with a traditional chest drain. There was no significant difference in the characteristics of the two matched groups (p > 0.05). In both groups, patients were placed on -15 cmH2O during the day and whilst sleeping were placed on Water Seal (traditional sytems) or Gravity Mode (Thopaz). Criteria for removing the drain at -15 cmH2O were as follows: Traditional systems required an absence of air leak following repeated expiratory efforts, whilst on Thopaz required a flow of < 40 ml/min, stable on the graph for 8h. On both systems a pleural effusion < 400 ml/24h was required. Results Patients managed with Thopaz had a significantly shorter duration of chest tube drainage (P < 0.0001) and shorter hospital stay (P < 0.001) when compared to patients on traditional systems (Figure 1). 6 6.0 5 4 4.5 4.4 3 2.5 2 Days of drainage Days in hospital 1 0 Traditional System Thopaz Figure 1: Length of chest drainage and length of hospital stay for patients on traditional systems compared to Thopaz. 11 The use of Thopaz significantly (P < 0.001) reduced hospital costs by an average of €751 per patient (Figure 2). 2500 12 € 751 € 2’553 2000 1500 € 1’802 1000 Hospital savings per patient Hospital cost per patient 500 0 Traditional System Thopaz Figure 2: Per patient cost and savings associated with using Thopaz. Benefits of Thopaz were evident from the first patient, however the maximum benefit was achieved by patient number 40. 3.5 3.0 Days of drainage for traditional systems 2.5 Days of drainage for Thopaz 2.0 10 20 30 40 50 Patients ordered by date of operation Figure 3: Learning curve of Thopaz, showing that maximum benefit in using Thopaz, as measured by duration of chest drainage, is achieved after 40 patients. Conclusions l Compared with traditional devices, the use of Thopaz was beneficial from its initial application. l The learning curve was short and did not affect the efficiency of the system. l Thopaz reduced the duration of chest tube drainage and length of stay thereby significantly reducing the costs to the hospital. l Study limitations include prior experience with digital drainage devices in this hospital, and that the study population included only pulmonary lobectomies. Thopaz Portable Suction Systems in Thoracic Surgery: An end user assessment and feedback in a tertiary unit. S. Rathinam, A. Bradley, T. Cantlin, P. B. Rajesh Journal of Cardiothoracic Surgery. (2011) 6:59. Open access article available online. Study Background & Design Traditional chest drainage has been achieved by connecting the chest drain bottles to wall suction. However, the negatives include; impaired patient mobility, variable suction applied to the patient, infection risk, and the assessment of air leak being subjective. Thopaz is a portable chest drain which allows for mobilization of the patient, and has scientific digital flow recordings with an inbuilt alarm system. After 2.5 months of using Thopaz on 120 patients, 15 clinical staff on a thoracic ward were asked to evaluate Thopaz in a structured format. Staff responses graded their satisfaction on a scale of Excellent, Very good, Good, Satisfactory, Needs Improvement, or Poor. Patients with pneumo-thoraces who had chest drains and wall suction prior to surgery who then had Thopaz following surgery were also requested to give their feedback. Results The results of the survey of clinical staff satisfaction of Thopaz are as follows: 13% 13% 20% 54% Excellent V. Good Good Satisfactory Could be improved Poor Figure 1: Assessment on the instructions for use of Thopaz. 100 75 6% 6% 20% 27% 34% 50 34% 48% 40% 40% 25 0 20% 27% 6% Vacuum Setup 34% 6% 6% Air Flow Rate 20% 6% Graphic Display Legibility Figure 2: Assessment on the functionality of Thopaz. 20% Alarm System Excellent V. Good Good Satisfactory Could be improved Poor 13 100 75 14 27% 27% 40% 50 25 40% 0 20% Tubing 46% 27% Canister 53% 20% Excellent V. Good Good Satisfactory Could be improved Poor Changing Disposables Figure 3: Assessment on using the disposables of Thopaz. 13% 87% Excellent V. Good Good Satisfactory Could be improved Poor Figure 4: Overall assessment of Thopaz experience. Additional, subjective feedback from patients was that they liked the light, compact design, and the quietness compared to the sound of bubbling. Clinical feedback was that they liked the mobilisation of the patients and scientific removal of chest drain. Conclusions l Thopaz was found to be user friendly and liked by staff and patients. l Additional clinical benefits cited were objective decision making on when to remove the chest tube, improved patient mobilisation and therefore physiotherapy, a reduction in use of x-rays, and improved infection control due to reduced risk of spillages. The benefits of digital air leak assessment after pulmonary resection: Prospective and comparative study J. M. Mier, L. Molins, J. J. Fibla Cirugía Española. (2010). 87(6):385–389 15 Study Background & Design With traditional systems, the grading of air leaks still relies on the measurement of “bubbles in a chamber”, a method inherently prone to subjective interpretation and observer variability. To this end a prospective, consecutive and comparative study was performed to evaluate the efficacy of digital devices (Thopaz and the now defunct DigiVent) in measuring the postoperative air leak compared to a traditional device and how this impacts upon the decision to withdraw chest tubes after lung resection. A total of 75 patients who underwent elective pulmonary resection were equally divided into the three groups. There was no significant difference between the groups regarding demographics or respiratory function. Negative pressure set on the systems was -15 cmH2O from the closure of the chest wall muscle to the time when the drain was removed. The chest drain was removed when < 10 ml/min for digital devices and no bubbles for the traditional system was maintained for 12 h. Pleural effusion needed to be below 200 ml in 24 h. Results Chest tube removal occurred earlier for Thopaz than occurred for DigiVent and the traditional system. 5 4 4.5 3 3.3 2.4 2 Traditional System DigiVent Thopaz Figure 1: The length of drainage in days for a Traditional Chest Drain, DigiVent and Thopaz. The standard deviation for the traditional system was far greater than occurs for either DigiVent or Thopaz, demonstrating that inter-observer differences were reduced when using digital devices. 4 16 3.6 3 2 1 1.0 1.0 0 Traditional System DigiVent Thopaz Figure 2: The standard deviation for length of drainage in days for a Traditional Chest Drain, DigiVent and Thopaz. Additional, subjective feedback was that patients and nurses were more comfortable with digital devices, whilst the surgeons felt they obtained more objective information. Conclusions l The digital and continuous measurement of air leak instead of the currently used traditional systems reduced the chest tube withdrawal and hospital stay by more accurately and reproducibly measuring air leak. l The Thopaz alarm mechanism is very useful and the integrated suction provides significant independence to the patient. l It is possible to remove the drain significantly earlier in patients with Thopaz. Had the sample size been larger, the result might have been even more conclusive. l Study limitations were that the sample size was small and the lack of randomised groups. Postoperative chest tube management: measuring air leak using an electronic device decreases variability in the clinical practice G. Varela, M.F. Jimenez, N.M. Novoa, J.L. Aranda European Journal of Cardio-thoracic Surgery. (2009). 35:28—31 17 Study Background & Design The aim of this study was to measure inter-observer variability and its impact upon deciding when to withdraw chest tubes after lung resection and to evaluate if the use of an electronic device to measure postoperative air leak decreased variations in clinical practice. In a prospective randomized study, 61 patients undergoing pulmonary resection were randomly assigned to either the digital group (using the now defunct DigiVent chest drain) or the traditional group (on standard water seal). Having established the chest tube withdrawal criteria, two thoracic surgeons with comparable clinical experience independently evaluated whether to withdraw the chest tube. Each was blinded to the decision of their counterpart. Fifty-four observations were recorded in the traditional group and 67 observations were recorded in the digital group. The inter-observer variability and kappa coefficient were calculated. Results The inter-observer variability on when to remove the chest tube is much greater for the Traditional System when compared to the Digital System. Digital System Observer 2 decision to remove chest tube Observation 1 Decision to Remove Chest Tube Yes No Yes 32 3 No 1 31 Traditional System Observer 2 decision to remove chest tube Observation 1 Decision to Remove Chest Tube Yes No Yes 22 12 No 5 15 Figure 1: Showing the inter-observer variability for the Traditional and Digital Systems. The Kappa Coefficient shows poor agreement between observers for the Traditional System and good agreement for the Digital System. 1.0 18 0.8 0.88 0.6 0.4 0.37 0.2 Traditional System Digital System Figure 2: Kappa Coefficient showing agreement between clinical decisions on whether to remove the chest tube for the Traditional System and Digital System. A low Kappa Coefficient suggests poor agreement between observers, whereas a high Kappa Coefficient suggests good agreement between observers. Conclusion l There was a high rate of disagreement as to when to remove chest tube after lung resection for the traditional water seal system, and a high rate of agreement when an electronic device with a digital air flow meter was used. The quantification of postoperative air leak. Cerfolio R.J., Bryant A.S. (2009). Multimedia Manual of Cardiothoracic Surgery. DOI:10.1510/mmcts.2007.003129. Open access article available online. 19 Study Background & Design Air leaks are the most frequent cause of prolonged hospital stay, increased cost and patient dissatisfaction. The management of chest tubes in patients with air leaks is optimized when the air leak is scientifically evaluated. To eliminate subjectivity, companies have developed digital pleural drainage systems that are able to quantify the size of air leaks in ml/min. In this study, 98 patients undergoing elective pulmonary resection were recruited, 48 into the Thopaz group and 50 into the traditional system group. Patient age, body mass index, pulmonary function tests and types of procedures were similar in both groups. Results Comparison shows that patients on Thopaz have a significantly reduced duration of chest drainage than those on the Traditional System. There was a reduction in length of hospital stay for the Thopaz group, however this did not reach significance. 5 4 4.4 4.6 3.9 3 3.0 Days of drainage (p=0.04) Days in hospital (p=0.15) 2 Traditional System Thopaz Figure 1: Showing a comparison between a Traditional System and Thopaz in the duration of chest drainage, and length of hospital stay. Comparison shows that pneumothorax patients on Thopaz have a significantly reduced length of hospital stay than those on the Traditional System. 7 20 6.5 6 3.9 5.4 5 Days in hospital (p=0.03) 4 Traditional System Thopaz Figure 2: Showing a comparison between a Traditional System and Thopaz in the length of hospital stay for pneumothorax patients. Conclusion l Treatment of air leaks has evolved to improved chest tube management through the use of scientific measures, leading to the earlier removal of chest tubes, decreased pain and morbidity and the early discharge of patients. l There is little question that digital air leak devices are the future of the bedside management of air leaks. l Further studies are needed to determine their efficacy on all patients requiring drainage, and to determine costs savings. 21 Medical Vacuum Technology for Healthcare Professionals Local contact: Medela AG Lättichstrasse 4b 6341 Baar, Switzerland www.medela.com Australia Medela Pty Ltd. Medical Technology 3 Arco Lane Heatherton, Vic, 3202 Australia Phone +61 (0) 3 9552 8600 Fax +61 (0) 3 9552 8699 [email protected] www.medela.com.au Canada Medela Inc. 4160 Sladeview Cres., Unit #8 Mississauga, ON L5L 0A1 Canada Phone +01 905 608 7272 Fax +01 905 608 8720 [email protected] www.medela.ca UK Medela UK Ltd. 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