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Ann Thorac Surg 2004;77:1932-1937
© 2004 The Society of Thoracic Surgeons
a Department of Respiratory Diseases, Unit of Thoracic Surgery, "Umberto I" Regional Hospital, Ancona, Italy
Accepted for publication December 10, 2003.
* Address reprint requests to Dr Brunelli, Via S. Margherita 23, Ancona 60129, Italy
e-mail: alexit_2000{at}yahoo.com
| Abstract |
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METHODS: One hundred forty-five patients who underwent pulmonary lobectomy for lung cancer and with an air leak on the first postoperative day were prospectively randomly assigned to two groups: in group 1 (72 patients), chest tubes were placed on water seal on the morning of the first postoperative day; in group 2 (73 patients), chest tubes were on continuous suction (20 cm H2O). Eighty percent of the patients who underwent upper lobectomy had also a pleural tent procedure. Preoperative, operative, and postoperative variables were compared between the groups.
RESULTS: The two groups were evenly matched for preoperative and operative characteristics. No statistically significant differences were found between group 1 and group 2 in terms of air leak duration (6.5 versus 6.3, respectively; p = 0.9) and the incidence of prolonged air leak cases (27.8% versus 30.1%, respectively; p = 0.8). Similar results were obtained when the analysis was corrected for the length of the stapled parenchyma and the site of resection (upper and lower resections) or restricted to patients with a forced expiratory volume in 1 second less than 80% of predicted. Water seal patients had increased postoperative complications compared with suction patients (31.9% versus 17.8%, respectively; p = 0.056).
CONCLUSIONS: Chest tubes placed on water seal after pulmonary lobectomy were generally well tolerated and safe; however, they did not reduce the duration of air leak or the incidence of prolonged air leak compared with suction.
| Introduction |
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The objective of this prospective randomized study was to verify whether water seal chest tubes drainage reduced the duration of air leak compared with chest tubes placed on suction in patients undergoing pulmonary lobectomy for lung cancer.
| Patients and methods |
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Resectability was evaluated by means of computed tomography (CT) scan, bronchoscopy, and, when indicated, mediastinoscopy. We assessed operability by means of arterial blood gas analysis, pulmonary function tests, electrocardiogram, echocardiography, and more invasive cardiologic tests if needed. A symptom-limited stair-climbing test was systematically administered for risk stratification to all patients who were able to perform it. Operative exclusion criteria were a predicted postoperative forced expiratory volume in 1 second (ppoFEV1) less than 30% in association with a height lower than 12 m reached at the stair-climbing test, and a hemodynamically unstable state.
All pulmonary lobectomies were performed at a single institution by one of four attending thoracic surgeons through a lateral muscle-sparing thoracotomy. The operative technique was standardized for all the surgeons. We used mechanical staplers to develop incomplete fissures in 80% of patients and to close the bronchus in all patients in the study. Approximately 20% of patients had completely developed or filmy fissures, which did not require the use of staplers. After completion of the lobectomy, a mediastinal lymphadenectomy was performed in all patients. After reinflation of the operated lung, air leaks were pinpointed by squirting sterile water over the lung and sutured. Upper lobectomies and bilobectomy patients underwent a pleural tent procedure, whenever possible (with the exception of extrapleural resection), according to the technique previously described [4]. Approximately 80% of upper lobectomies in this series had pleural tenting.
Two 28F chest tubes were positioned before the closure of the thoracotomy, one anteriorly into the apex and one in a posteroinferior position. During the immediate postoperative period, we placed the chest tubes on suction (20 cm H2O) until the morning of the first postoperative day, at which time the patients without an air leak were managed with water seal chest tubes and were not included in the present analysis. Patients with an air leak present on the morning of the first postoperative day were randomly assigned to one of two groups: in group 1, the chest tubes were placed on water seal; in group 2, the chest tubes remained on continuous suction (20 cm H2O), with the exception of transfers within the hospital, until no air leak was evident. If an air leak persisted for more than 10 days, we converted the chest tubes to water seal, and then after 24 hours we connected them to a Heimlich valve and discharged the patients unless otherwise contraindicated.
Of the patients in the two groups, 3 patients died and 3 patients required mechanical ventilation for more than 24 hours and were, therefore, excluded from the analysis. Thus, a total of 145 patients (28 female, 117 male) with an air leak on postoperative day 1 formed the dataset of the present study (group 1, water seal, 72 patients; group 2, suction, 73 patients).
The following procedures were performed for each group: group 1, 23 right upper lobectomies, 19 left upper lobectomies, 14 left lower lobectomies, 8 right lower lobectomies, 5 right lower bilobectomies, 2 middle lobectomies, and 1 right upper bilobectomy; group 2, 24 left upper lobectomies, 20 right upper lobectomies, 10 left lower lobectomies, 7 right lower lobectomies, 7 right lower bilobectomies, 3 middle lobectomies, and 2 right upper bilobectomies.
The presence of an air leak was checked twice daily during morning and evening rounds. The patients were instructed to make repeated efforts of forced expiration and cough in order to reveal the presence of an air leak. We elected to not perform chest radiographs routinely and to obtain them only when clinically indicated (reduced breath sounds at auscultation, increased bronchial secretions, fever with leukocytosis, reduced oxygen saturation, a suspicion of chest tube malfunctioning, and so forth). This is a standard policy at our institution. Therefore, a systematic study on the occurrence of residual pleural spaces was not possible [1, 2].
During the postoperative period, chest physiotherapy and incentive spirometry were administered to all patients, in addition to bronchodilators if needed. We removed the chest tubes when no air leak was evident (after a 24-hour clamping trial), and when the pleural effusion was less than 200 mL in 24 hours. This policy of chest tube removal is the current standard practice at our institution.
For the purpose of this study, an air leak that persisted for more than 7 days was arbitrarily termed "prolonged." Two different types of drainage apparatuses were used during the period of the study. As one of the two types of drainage device did not have a leak-meter, a quantitative analysis of the air leak was not possible in this study. The two types of drainage apparatuses were evenly distributed between the groups. Furthermore, we tested them by means of a water-manometer to assure that a negative pressure of 20 cm H2O was applied to the chest tubes.
For the purpose of the present study, a concomitant cardiac disease was defined as follows: previous cardiac surgery, previous myocardial infarction, history of coronary artery disease, and current treatment for hypertension, arrhythmia, or cardiac failure. As a measure of comorbidity, we used the Charlson comorbidity index [5]. The following complications, occurring within 30 postoperative days (or over a longer period if the patients remained hospitalized), were considered for the analysis: atelectasis requiring bronchoscopy, pneumonia, pulmonary edema, adult respiratory distress syndrome, pulmonary embolism, pleural empyema, cardiac failure, arrhythmia requiring medical treatment, myocardial infarction, acute renal failure, and stroke.
Statistical analysis
The sample size of this study was set to obtain a statistical power of 0.99 for detecting an expected difference of air leak duration of 2 days between the groups (according to the mean difference reported by Marshall and associates [2]) with a two-tailed significance level of 0.05.
The Shapiro-Wilk test of normality and the standardized normal probability plot were used to evaluate the normal distribution of the numerical variables. The numerical variables with a normal distribution were compared by means of the unpaired Student's t test. Those without a normal distribution were compared by means of the Mann-Whitney test. The
2 test or the Fisher's exact test, when appropriate, were used to compare categorical variables.
The following preoperative variables were considered: the patient's age and sex, FEV1, forced expiratory capacity (FVC), FEV1/FVC ratio, predicted postoperative FEV1 (ppoFEV1), residual volume to total lung capacity ratio (RV/TLC ratio), carbon monoxide diffusion lung capacity (DLCO), arterial oxygen tension (PaO2), arterial carbon dioxide level (PaCO2), preoperative hemoglobin and serum albumin concentrations, neoadjuvant chemotherapy, smoking history (pack-years), and use of systemic steroids. The FEV1, FVC, ppoFEV1 and DLCO were expressed as a percentage of predicted value for age, gender and height according to the European Community for Steel and Coal prediction equations [6]. The ppoFEV1 was calculated based on the functioning segments removed during operation, and it was estimated by CT scan and bronchoscopy [7]. If the calculated ppoFEV1 was less than 50% of the predicted value, a quantitative lung perfusion scan was performed [8]. The DLCO was measured by the single-breath method. We computed the number of pack-years of smoking as the total number of years smoked multiplied by the average number of cigarettes smoked per day, divided by 20.
Operative variables included the side (right and left) and site (upper and lower) of resection, the presence of pleural adhesions and the length of the stapled parenchyma (cm). For the purpose of this study, we classified the following procedures as "upper" resections: right and left upper lobectomies, right upper bilobectomy and middle lobectomy. "Lower" resections included right and left lower lobectomies, and right lower bilobectomy. Only dense pleural adhesions occupying more than 30% of a lobe or more than one lobe were taken into consideration for the analysis. We measured the length of the stapled parenchyma using the length of the stapler cartridges used on the deflated lung.
Postoperative variables included the duration of air leak in days, the presence of a prolonged air leak (prolonged air leak), the duration of chest tube use in days, the quantity of pleural effusion during the first postoperative 48 hours, the presence of other complications, the length of postoperative hospital stay in days, the corrected duration of air leak, and chest tube time per centimeters of stapled parenchyma [2].
To assess whether placing the chest tubes on water seal influenced the rate of reduction of postoperative air leak compared with suction, we compared the reduction in the number of patients with air leak occurrence in successive postoperative periods (< 2 days, < 4 days, < 6 days, < 8 days, and < 10 days).
All test were two-tailed, with a significance level of 0.05, and were performed on the statistical software Statview 5.0 (SAS, Cary, NC).
| Results |
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Patients with chest tubes on water seal had an increased rate of postoperative cardiopulmonary complications (31.9% versus 17.8%, p = 0.056, Fisher's exact test). In particular, they had a trend of increased incidence of pneumonia (13.9% versus 6.8%, p = 0.18, Fisher's exact test) and arrhythmia (13.9% versus 5.5%, p = 0.10, Fisher's exact test). In the two groups, a similar proportion of patients had a concomitant cardiac disease (water seal, 59.8% versus suction, 46.6%; Fisher's exact test, p = 0.15) and diabetes (water seal, 11.1% versus suction, 11.0; Fisher's exact test p = 0.99). Furthermore, the Charlson comorbidity index did not differ between the water seal and the suction groups (2.3 versus 2.5; p = 0.5). No patients in either group required a chest tube reinsertion after removal.
Tables 3 and 4 show the results of the comparison between patients with water seal and suction chest tubes stratified according to the site of resection. Either in upper and lower resection, no differences were noted between the two groups in terms of air leak duration and occurrence of prolonged air leak. In each of these subgroups, the patients on water seal and those on suction were evenly matched for preoperative and operative characteristics.
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Finally, Table 5 shows that the rate of the reduction of air leak was not statistically different in the two groups. The patients in group 2 with an air leak lasting for more than 10 days were converted to water seal and eventually discharged with a Heimlich valve. They did not show any difference in terms of air leak duration, compared with the patients in group 1 (18.6 versus 19.3, respectively; p = 0.8).
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| Comment |
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Theoretically, placing chest tubes on suction improves the apposition of the visceral and parietal pleurae, facilitating the sealing of air leaks. This approach seems more reasonable particularly after a pulmonary lobectomy when a greater pleural residual space is created compared with minor resections. On the other hand, the suction applied to the tubes may lead to an increase in the volume of air leaking from the parenchyma, hindering the sealing process [2]. Therefore, we wanted to test the application of water seal on the chest tubes of a homogeneous series of patients undergoing pulmonary lobectomy for NSCLC.
Our results showed that, compared with suction, water seal did not reduce the duration of air leak, the incidence of prolonged air leak, and the length of hospital stay in these patients. Even when the analysis was corrected for the length of the stapled parenchyma [2], stratified for the site of resection (upper and lower) or restricted to patients with a FEV1 less than 80% of predicted (presumably with a more damaged and fragile lung parenchyma), no significant differences between the groups were noted in terms of air leak duration.
These results are in contrast with those reported by Cerfolio and colleagues [1] and Marshall and associates [2]. Differences in the size of the samples (18 patients with lobectomy in the water seal group of Cerfolio and coworkers; 15 patients with lobectomy in the water seal group of Marshall and coworkers), in the study protocol (water seal applied on the second postoperative day in the Cerfolio analysis, immediately after the operation in the Marshall analysis), and in the type of procedures included in the study (wedge, segmentectomy, and lobectomy in the two studies cited above; only lobectomy in the present study) may explain these different findings. Furthermore, the studies cited above [1, 2] did not stratify the results for the type of operation performed (wedge, segmentectomy, lobectomy), making the comparison between our study and theirs difficult.
We placed the chest tubes on suction the day of surgery, since we and our ethical committee considered safe a brief period of suction immediately after operation, as in another trial [1]. We did not think this flawed the results, however, as randomization occurred on the morning of the first postoperative day and only among the patients with an air leak present at this time. We think this allowed a reliable estimate of the effect of water seal or suction on air leak duration.
More than 55% of our patients on the water seal group with an air leak on postoperative day 1 had their air leaks stopped by the fourth postoperative day. This finding was similar to that reported by Cerfolio and coworkers (67%) [1]. However, in our suction group a comparable proportion of patients (53%) had their air leaks stopped by the fourth postoperative day, compared with only 7% of the patients in the Cerfolio study [1]. That may be explained in part by the fact that we performed routinely a pleural tent in upper lobectomies and bilobectomies whenever possible. We and other authors previously showed that this procedure was effective in reducing the duration of air leak [1113]. Therefore, the rate of reduction of air leak in our study was not influenced by the modality of the chest tube management.
Another interesting finding was that, although water seal was generally safe and well tolerated by our patients who were able to ambulate early and more freely, a trend toward increased morbidity was noted in this group. In particular, patients in the water seal group had an incidence of pneumonia and arrhythmia twice as high as the patients in the suction group. Whether these complications were related to a reduced lung expansion, with a consequent increase in sputum retention and hypoxemia, remains a matter of speculation that needs to be verified by other larger trials.
In conclusion, even though chest tubes placed on water seal after pulmonary lobectomy were safe and well tolerated, they did not reduce the duration of air leak or the incidence of prolonged air leak. Based on the results of this analysis, our current practice is to use a moderate suction (10 cm H2O) overnight and water seal during the day for allowing an early and free mobilization of the patients. Whether this alternate moderate suction chest tube modality provides an advantage in terms of air leak duration has to be tested by another prospective randomized trial.
| References |
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