The implementation of a digital chest drainage system significantly reduces complication rates after lobectomy a randomized clinical trial

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1 THORACIC SURGERY DOI: /kit The imlementation of a digital chest drainage system significantly reduces comlication rates after lobectomy a randomized clinical trial Tomasz Marjański, Adam Sternau, Witold Rzyman Deartment of Thoracic Surgery, Medical University of Gdansk, Gdańsk Kardiochirurgia i Torakochirurgia Polska 2013; 10 (2): This work was resented at the 5 th Congress of the Polish Society of Cardio-Thoracic Surgeons (May 24-26, 2012, Krakow). Abstract Aim of the study: The aim of the study was to evaluate the imact of imlementing a digital chest drainage device with regulated suction during ostoerative care following a ulmonary lobectomy. Material and methods: Sixty-four atients who underwent a lobectomy at the Deartment of Thoracic Surgery of the Medical University of Gdańsk between June 2011 and January 2012 were included in this study. The atients were randomly divided into two grous. During the ostoerative eriod, the atients in the study grou received thoracic drainage using digital chest drainage or a conventional glass bottle. The drain was withdrawn when the daily volume did not exceed 350 ml and there was no air age for at least 6 hours. Results: The atients from the study and the control grous did not significantly differ with regard to the following arameters: mean age, hysiological test results, resence of concomitant diseases, and surgical access to the chest. During the ostoerative eriod, no significant differences in the drainage duration were found (Thoaz: 4 days, controls: 4 days, = 0.919). Similarly, the eriod of hositalization did not differ significantly. The general comlication rate was 37%, with common comlications including: atrial fibrillation (19%), atelectasis requiring bronchial asiration (9%), and rolonged air (8%). The comlication rate in the Thoaz grou was significantly lower (25%) than in the control grou (50%) ( = 0.039). There was no mortality in either grou during the ostoerative eriod. Conclusions: Withdrawing the drainage device at the daily volume of 350 ml together with the imlementation of a light and comact digital chest drainage kit significantly reduces the comlication rates after lobectomy. Key words: lobectomy, leural drainage, comlications. Streszczenie Cel racy: Ocena rzebiegu okresu ooeracyjnego o wycięciu łata łuca w zależności od zastosowanej formy drenażu: drenażu cyfrowego z regulowaną siłą ssania i tradycyjnego drenażu butlowego. Materiał i metody: Pomiędzy czerwcem 2011 r. a styczniem 2012 r. do badania włączono 64 acjentów oddanych lobektomii w Klinice Chirurgii Klatki Piersiowej Gdańskiego Uniwersytetu Medycznego. Pacjenci byli losowo kwalifikowani do jednej z dwóch gru. W gruie badanej acjenci w okresie ooeracyjnym drenowani byli rzy zastosowaniu drenażu cyfrowego Thoaz Medela. W gruie kontrolnej o zabiegu stosowano klasyczny drenaż dwubutlowy. Dren usuwano rzy dobowej objętości nierzekraczającej 350 ml i braku rzecieku owietrza od minimum 6 godzin. Wyniki: Pacjenci gruy badanej i kontrolnej nie różnili się istotnie omiędzy sobą: średnim wiekiem, wynikami testów czynnościowych, częstością chorób towarzyszących i odsetkiem zabiegów wykonanych z dostęu wideotorakoskoowego. W okresie ooeracyjnym nie stwierdzono istotnych różnic w medianie długości utrzymywania drenażu (Thoaz 4 dni, kontrola 4 dni, = 0,919). Podobnie, nie stwierdzono różnic w długości hositalizacji (Thoaz 6 dni, kontrola 5,5 dnia, = 0,559). Częstość wystęowania owikłań wynosiła 37%. Najczęstszymi stwierdzanymi owikłaniami były: migotanie rzedsionków (19%), niedodma wymagająca odessania wydzieliny (9%) oraz rzedłużony rzeciek owietrza (8%). W okresie ooeracyjnym nie było zgonów. U acjentów z gruy Thoaz istotnie rzadziej stwierdzano owikłania (25%) niż w gruie kontrolnej (50%) ( = 0,039). Wnioski: Usuwanie drenażu rzy dobowej objętości 350 ml wraz z zastosowaniem lekkiego, rzenośnego zestawu drenażu cyfrowego ozwala znacząco obniżyć częstość wystęowania owikłań o lobektomii. Słowa kluczowe: lobektomia, drenaż ołucnej, owikłania. Address for corresondence: dr n. med. Tomasz Marjański, Deartment of Thoracic Surgery, Medical University of Gdansk, Smoluchowskiego 17, Gdańsk, tel , fax: , marjanski@gumed.edu.l Kardiochirurgia i Torakochirurgia Polska 2013; 10 (2) 133

2 The imlementation of a digital chest drainage system significantly reduces comlication rates after lobectomy Introduction Chest drainage duration is the most significant factor influencing the duration of ostoerative hositalization after ulmonary resection less extensive than neumonectomy [1, 2]. In the resence of an air, retaining the drain is universally acceted. Moreover, withdrawing the drain while a high daily volume of fluid is roduced is controversial [3]. Recently, in thoracic surgery deartments, conventional water seal chest drainage devices have begun to be relaced by digital chest drainage devices. Digital drainage allows for the objective evaluation of air age [4, 5]. The recise regulation of intraleural ressure enabled by the device allows for a shift from simle leural drainage to an innovative treatment modality [6]. Thanks to the unification of this treatment, managing multicenter trials and comaring results from different centers has become more feasible. Aim of the study The aim of the study was to evaluate the influence of digital drainage on comlication rates, drainage duration, and hositalization time after lobectomy. Material and methods Patients, aged 44-79, qualified for lobectomy according to the commonly acceted ERS/ESTS rotocol [7], entered this rosective trial. The atients free from significant concomitant diseases [with the excetion of mild chronic obstructive ulmonary disease (COPD)], who had good or very good erformance status (PS 0-1) and low risk of comlications during general anesthesia [ASA (American Society of Anesthesiologists) I-II], were randomly assigned to one of the two study arms in a ratio of 1 : 1 after having rovided their written informed consent. The exclusion criteria of the study consisted of: reoerative treatment with chemo- or radiotheray and clinical and/or radiological features of active inflammation (esecially asergillosis, lung abscess, neumonia, or tuberculosis). Patients in whom a decision to change the extent of the resection was undertaken intraoeratively were also excluded. Finally, atients who withdrew their drains accidentally or had them withdrawn due to ostoerative sychosis were excluded from the study. Between June 2011 and January 2012, 64 atients entered the study. After roviding their written informed consent, the atients were randomized using the cointoss method and allocated to one of the two study grous. Grou I was the study grou while grou II was the control grou. Patients from the study grou received ostoerative drainage using a digital drainage device (Thoaz, Medela AG, Switzerland). Patients from the control grou received ostoerative drainage using classic Sherwood glass bottles. Suction was obtained via a central wall suction system. All atients underwent a simle lobe excision with systematic lymh node excision. After the surgery, a single 28F thoracic drain was left. During the first 2 ostoerative days, drain suction was set at 15 cm H 2 O. Subsequently, active suction was relaced by gravitational drainage. The decision to withdraw the drain was evaluated once a day, based on two universally acceted conditions: the daily volume of the drained fluid must not exceed 350 ml and no air age must be resent (defined as the absence of bubbles in the water seal bottle during coughing or the alication of the Valsalva maneuver). The atients from the control grou were asked to cough a few times during the morning visits. The resence of air age was observed by a thoracic surgeon with sufficient rofessional exerience, who decided whether to withdraw the drain. In the study grou, the drain was removed when the air was between 0 and 20 ml/min, as determined with the digital device; the readings from the revious 6 hours of drainage were also analyzed during the morning visits. The study was designed to find the differences between the ostoerative course in the two different drainage systems. The eriod between the cessation of air age and the drain withdrawal was not recorded due to unreliable data in the glass bottle system. The amount of air age in the digital drainage grou was not recorded for the same reason. The study was aroved by the University Ethics Committee of the Medical University of Gdańsk (Aroval: 400/2009). To comare the results in an interval scale characterized by normal distribution, a Student s t-test for indeendent samles was alied. The data in an interval scale not characterized by normal distribution were comared using a Mann-Whitney U test. The data in the nominal scale were comared using a χ 2 or Fisher s exact test, if necessary. A significance level of < 0.05 was assumed for the verification of all the hyotheses. Results The data acquired from all the atients were subjected to statistical analysis. Age, gender, frequency of concomitant diseases, results of sirometry and hysiological tests, as well as smoking habit, were similar in both study grous (Table I). The rocedures erformed and the accessibility of the surgical site in both study grous are listed in Table II. Right lower lobectomy was more common in grou II, but the small samles of the subgrous suggest that this does not influence the end results. The most common athological status of the resected secimen was adenocarcinoma in stage IA, which is tyical for atients oerated on in our center. The athological stage and tye of the disease were similar in both study grous (Table III, Table IV). The mean drainage time was comarable in both study grous (Fig. 1). Similarly, the duration of hosital stay was comarable (Fig. 2). Significant differences were discovered when analyzing the ostoerative comlications. The comlication rate was significantly higher in the grou in which conventional glass bottle drainage was alied [grou II (glass bottle): 50%; vs. grou I (Thoaz): 25% = 0.039]. Cardiovascular and ulmonary comlications were most frequent (atrial fibrillation 38%, atelectasis requiring bron- 134 Kardiochirurgia i Torakochirurgia Polska 2013; 10 (2)

3 THORACIC SURGERY Tab. I. Comarison of the two study grous Parameter Grou I (Thoaz) Grou II (glass bottle) age (years) 63 (52-79) 63 (44-75) male gender frequency of concomitant diseases frequency of arterial hyertension frequency of diabetes mellitus frequency of coronary artery disease FEV 1 (dm 3 ) 1.66 ( ) 2.13 ( ) FEV 1 % 89 (47-118) 95 (59-128) FVC (dm 3 ) 3.00 ( ) 3.26 ( ) FVC% 98 (60-130) 103 (84-113) minute walk test distance (meters) smoking (ack years) 29 (0-60) 30 (0-75) FEV 1 forced exiratory volume in 1 second; FVC forced vital caacity Tab. III. Histology of the resected secimens Histological tye Grou I (Thoaz) Grou II (glass bottle) adenocarcinoma squamous cell carcinoma large cell carcinoma tyical carcinoid other malignancies benign chial asiration 19%, rolonged air 15%, redrainage 3%, bronchial stum fistula 1.5%, neumonia 1.5%). Other comlications that occurred in the study grous were: hemorrhage requiring reoeration (1.5%) and cerebral stroke (1.5%). Cardiovascular and ulmonary comlications were more common in the classical drainage grou (47%) than in the Thoaz grou (22%; = 0.035). A comarison of the ostoerative comlications in both study grous is resented in Table V. The comlete list of atients with comlications which occurred in the ostoerative eriod is resented in Table VI. There were no deaths during the ostoerative eriod. The daily amount of fluid (350 ml) at which it was accetable to remove the drain was higher than the 200 ml traditionally acceted in our deartment. In site of this, none of the atients were redrained due to the resence of fluid in the leural cavity. Only one atient in grou II was redrained due to neumothorax. Tab. II. Tyes of rocedures erformed in the study grous Procedure Grou I (Thoaz) Grou II (glass bottle) right uer lobectomy middle lobectomy right lower lobectomy left uer lobectomy left lower lobectomy access video-assisted thoracic surgery Tab. IV. Stages of the resected non-small cell carcinomas Stage of NSCLC Grou I (Thoaz) atients with NSCLC (n = 31) Grou II (glass bottle) atients with NSCLC (n = 31) IA IB IIA IIB IIIA NSCLC non-small cell lung cancer ercentage of atients grou I: Toaz days Fig. 1. Comarison of drainage times grou II: Glass bottle Discussion In 1875, Bülau introduced the underwater drainage tube for the leural cavity. It became a simle, very efficient and safe method of evacuating air and fluid from the leural cavity. The rinciles of chest drainage have not changed significantly since the 19 th century. The glass bottle used for chest drainage became a trademark of thoracic surgery. Kardiochirurgia i Torakochirurgia Polska 2013; 10 (2) 135

4 The imlementation of a digital chest drainage system significantly reduces comlication rates after lobectomy ercentage of atients Tab. V. Comlication rates in the study grous Comlications Grou I (Thoaz) Grou II (glass bottle) comlication rate 25% 50% cardiovascular and ulmonary comlication rate 22% 47% atrial fibrillation 16% 22% rolonged air 6% 9% atelectasis requiring bronchial asiration 3% 16% redrainage 0% 3% grou I: Toaz days grou II: Glass bottle Fig. 2. Comarison of the durations of ostoerative hosital stay The ability to treat atients with chest drainage has since become a defining characteristic of the thoracic surgeon. Recently, the imlementation of digital chest drainage systems has altered the attitude towards leural drainage and made it a significant art of the ostoerative treatment. Modern devices, due to reeated ressure measurements, rovide constant ressure in the leural cavity, which romotes more sufficient lung exansion. Moreover, reliable air monitoring enables earlier drain withdrawal, concurrently reventing remature drain ulls. In our center, the most common indication for a ulmonary lobectomy is non-small cell lung cancer (NSCLC). All the atients are qualified for radical treatment during multidiscilinary meetings. The decisions are undertaken on the basis of universal oncological and hysiological rotocols. This rocedure facilitates homogeneity in this grou of atients. In such uniform grous of atients, even small imrovements in routine ostoerative care could translate into substantial benefits. In the resent study, an attemt was made to define the influence of the imlementation of a digital chest drainage device on the ostoerative hosital stay. Based on reorted observations, there is no significant difference in clinical arameters between the classical and the modern drainage systems during the ostoerative eriod, if the assumed volume of daily drainage that allows safe drain removal does not exceed 200 ml [8]. We decided to increase the accetable daily fluid drainage volume. There is no unequivocal consensus on the accetable amount of drainage flow for safely withdrawing the drain from the leural cavity. Traditionally, the limit was established at ml/24 hours. Encouraging results of studies that removed the drain at the daily volume of 450 ml [3], or did not even take the daily volume of drainage into considera- Tab. VI. Detailed analysis of comlications Patient, age, oeration Comlication Patients with comlications (n = 8) from grou I (Thoaz) PC, 60, right uer lobectomy atelectasis requiring asiration BE, 60, right uer lobectomy atrial fibrillation DI, 75, right uer lobectomy atrial fibrillation SW, 64, right uer lobectomy atrial fibrillation KJ, 79, middle lobectomy atrial fibrillation, ersistent air BR, 76, left uer lobectomy atrial fibrillation, ersistent air KK, 57, right lower lobectomy neumonia SL, 67, right uer lobectomy cerebral stroke Patients with comlications (n = 16) from grou II (glass bottle) SJ, 65, left lower lobectomy atelectasis requiring asiration MW, 74, middle lobectomy atelectasis requiring asiration CM, 53, right uer lobectomy atelectasis requiring asiration GW, 57, right uer lobectomy atelectasis requiring asiration WE, 54, left lower lobectomy atrial fibrillation UK, 70, left uer lobectomy atrial fibrillation CS, 71, left uer lobectomy atrial fibrillation PR, 64, left lower lobectomy atrial fibrillation BT, 55, right lower lobectomy BR, 75, left uer lobectomy KA, 53, right lower lobectomy atrial fibrillation, atelectasis requiring asiration atrial fibrillation, ersistent air atrial fibrillation, ersistent air BW, 58, right uer lobectomy recurrent neumothorax BU, 67, right uer lobectomy hematoma, redrainage SG, 44, right lower lobectomy hematoma, reoeration KM, 75, left lower lobectomy ersistent air, bronchial stum fistula, chronic emyema WM, 69, left lower lobectomy redrainage due to neumothorax video-assisted thoracic surgery 136 Kardiochirurgia i Torakochirurgia Polska 2013; 10 (2)

5 THORACIC SURGERY tion [9], led us to set the accetable daily drainage volume level at 350 ml. This volume reresents the hysiological daily roduction of fluid by the leural cavity [1]. Desite the more liberal accetable daily fluid volume, none of the 64 atients who entered the resent study had to be redrained due to the resence of fluid in the leural cavity. In the resent study, we did not discover any differences between the atients in the study and control grous ertaining to the drainage time or the duration of hosital stay. These two arameters usually strictly correlate [1, 2]. The results of this study do not confirm the results of revious studies, which reorted a reduction of 1 day in ostoerative stay [5, 10]. It should be emhasized that the differences between the modern and classical drainage systems may be observed when the daily fluid limit is relatively large. When the daily volume does not exceed 200 ml, the two tyes of drainage tend to be similar. Digital drainage devices, in contrast to classical drainage, enable the objective evaluation of residual air age, which allows the drain to be withdrawn within u to 2 days ostoeratively in 85% of atients [11]. This benefit of gathering objective information about air age could be esecially useful if the accetable daily drainage volume is sufficiently high. It seems that the limit defined in this study (a daily fluid volume of 350 ml) could be still too low to demonstrate the clinical difference resulting from the imlementation of digital chest drainage. The drainage eriod could be shortened, in comarison to classical drainage, if the accetable daily fluid volume was equal to or exceeded 400 ml [10, 11]. Revealing the significant decrease in comlication rates in the digital drainage grou was the most imortant result of this study. Desite the equal drainage time in both study grous, a clear 50% reduction in general comlications and a 54% reduction in cardiovascular and ulmonary comlications were found. It is difficult to find a recise exlanation for the demonstrated reduction in comlications. The benefit constituted by this reduction of comlications is not discussed widely in the literature. It is surrising that such a slight intervention as changing the drainage tye would result in so significant a reduction in comlication rates. The general comlication rate in grou II was mainly affected by atelectasis, atrial fibrillation and ersistent air s. The decision to erform bronchial asiration is undertaken subjectively by a hysician and is based on the results of a clinical examination and chest X-ray. The study was not blinded, and in this case this could cause some bias. However, sufficient constant negative ressure in the leural cavity acquired by digital drainage definitely hels to exand the lung. The slightly higher number of atrial arrhythmias in grou II is the most difficult result to interret. The imortance of early ostoerative recovery and atient mobilization after ulmonary resections is well documented [12, 13]. In our oinion, the comact dimensions of the device together with its light weight facilitate mobility and efficient rehabilitation starting from the first ostoerative day, which definitely reduces erioerative risk. The third comlication affecting the results is the less common ersistent air in grou I. Due to regulated suction, the draining eriod is shorter with a tendency towards lower incidence of ersistent air s [10]. A rarely discussed asect of the new drainage devices is the noise reduction. Silence in the atient s room during the early ostoerative days reduces roblems with night slee [14]. This could be articularly imortant in hosital rooms without a central suction system, which require the use of loud installations that rovide suction. During the study eriod, a universal rotocol of negative ressure alied to the leural drain was imlemented. For the first 2 days following the surgery, the drains were under a negative ressure of 15 cm H 2 O; on subsequent days, the drainage was in gravitational mode. Studies that investigate the variation of ressures in the leural cavity occurring when emloying classical drainage have often revealed uncontrolled increases of ressure in the cavity, even to ositive s. The reason for significant increases in leural cavity ressure is the fluid retained in the connecting tube the tube between the chest and the drainage device. If the fluid remains in the connecting tube, the external suction is reduced to zero. Moreover, in the case of even minimal air age, the fluid retained in the chest tube blocks the outflow of air, causing ositive ressure and ossibly resulting in neumothorax. The Thoaz drainage device reeatedly measures the leural ressure at the level of the atient and constantly clears the connecting tube, significantly enhancing lung exansion in the very early ostoerative eriod that is when active atient rehabilitation has not yet commenced. Desite the fact that this observation involves only one atient in the control grou, it is worth mentioning that none of the atients in the Thoaz grou had to be redrained due to neumothorax after drain removal (in contrast to the traditional drainage grou). This observation is consistent with the exerience of our deartment with using modern drainage devices since This deendable system rovides an objective air age history for the last 24 hours, enabling otimal and safe decision making regarding drain removal. The main bias concerning this study, as well as others involving digital drainage devices, is the lack of blinding. This challenge seems difficult to overcome in the daily routine of the clinical deartment with a high number of daily rocedures. Secondly, the analysis of relatively small grous of atients established a very significant reduction of the comlication rate. As in every study with a small number of involved atients, there is a chance that the results are incidental. However, the roer recruitment, strict inclusion criteria resulting in atient grou homogeneity, and randomization entail that the results of this study must not be neglected. Conclusions Removing the chest drain at an elevated rate of 350 ml of daily fluid drainage is safe. The use of the Thoaz digital drainage device during the ostoerative eriod significantly reduces the rate of ostoerative comlications. Kardiochirurgia i Torakochirurgia Polska 2013; 10 (2) 137

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