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Eur J Cardiothorac Surg 2008;34:174-180. doi:10.1016/j.ejcts.2008.04.009
Copyright © 2008, European Association for Cardio-thoracic Surgery. Published by Elsevier. All rights reserved.
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Reduction of postoperative pulmonary complications after lung surgery using a fast track clinical pathway

Bernd M. Muehlinga,*, Gisela L. Haltera, Hubert Schelziga, Rainer Meierhenrichb, Peter Steffenc, Ludger Sunder-Plassmanna, Karl-Heinz Orenda

a Department of Thoracic and Vascular Surgery, University of Ulm, Steinhövelstrasse 9, 89075 Ulm, Germany
b Department of Anesthesiology and Critical Care Medicine, University of Ulm, Ulm, Germany
c Section of Pain Management, University of Ulm, Ulm, Germany

Received 30 November 2007; received in revised form 8 April 2008; accepted 14 April 2008.

* Corresponding author. Tel.: +49 731 500 54044; fax: +49 731 500 54002. (Email: bernd.muehling{at}uniklinik-ulm.de).


   Abstract
Top
 Abstract
1. Introduction
 2. Methods
 3. Results
 4. Discussion
 References
 
Background: Fast track programs, multimodal therapy strategies, have been introduced in many surgical fields to minimize postoperative morbidity and mortality. In terms of lung resections no randomized controlled trials exist to evaluate such patient care programs. Methods: In a prospective, randomized controlled pilot study a conservative and fast track treatment regimen in patients undergoing lung resections was compared. Main differences between the two groups consisted in preoperative fasting (6 h vs 2 h) and analgesia (patient controlled analgesia vs patient controlled epidural analgesia). Study endpoints were pulmonary complications (pneumonia, atelectasis, prolonged air leak), overall morbidity and mortality. Analysis was performed in an intention to treat. Results: Both study groups were similar in terms of age, sex, preoperative forced expiratory volume in one second (FEV1), American Society of Anesthesiologists score and operations performed. The rate of postoperative pulmonary complications was 35% in the conservative and 6.6% in the fast track group (p = 0.009). A subgroup of patients with reduced preoperative FEV1 (<75% of predicted value) experienced less pulmonary complications in the fast track group (55% vs 7%, p = 0.023). Overall morbidity was not significantly different (46% vs 26%, p = 0.172), mortality was comparable in both groups (4% vs 3%). Conclusion: We evaluated an optimized patient care program for patients undergoing lung resections in a prospective randomized pilot study. Using this fast track clinical pathway the rate of pulmonary complications could be significantly decreased as compared to a conservative treatment regimen; our results support the implementation of an optimized perioperative treatment in lung surgery in order to reduce pulmonary complications after major lung surgery.

Key Words: Fast track • Lung surgery • Pulmonary complications


   1. Introduction
Top
 Abstract
 1. Introduction
2. Methods
 3. Results
 4. Discussion
 References
 
Pulmonary resections represent the standard therapy in the treatment of benign and malignant lesions of the lung. Despite advances in surgical procedures and perioperative care patients undergoing major surgery are still threatened by postoperative complications such as myocardial ischemia, thromboembolism and pneumonia [1]. Risk factors influencing outcome in lung surgery are advanced age, preoperative pulmonary function and cardiovascular comorbidity [2]. In terms of major lung resections the incidence of postoperative pulmonary complications is up to 25%, mortality about 7.5% [3]. Frequent pulmonary complications are atelectasis requiring fiberbronchoscopy, pneumonia and prolonged air leak; postoperative pneumonia which represents a life threatening complication in patients undergoing lung resections is about 25% [4]. The rate of prolonged air leak more than 7 days is about 25.5% and results in an extended length of stay in hospital [5]. The overall morbidity after lung surgery ranges up to 39.6%, mortality about 6% depending on preoperative pulmonary function and extent of surgical procedure [6]. Video-assisted thoracic surgery (VATS) has been shown to be a feasible approach in lung lobectomies, but there is only thin evidence about its impact on morbidity and mortality and it is therefore not routinely performed [7,8]. Single interventions do not seem to be able to further improve outcome in these patients. Hence nowadays attention is being directed toward multimodal therapies that reduce surgical stress, optimize postoperative analgesia and adjust postoperative care in order to reduce complication rates after major surgical procedures [1]. So-called fast track recovery programs have been proposed for colorectal resections [9] and cholecystectomy [10]. With respect to lung resections only preliminary experiences with a non-standardized clinical pathway exist [11]. To date no fast track recovery program for major lung resections has been proposed in order to reduce postoperative pulmonary complications. Therefore, we have developed an optimized perioperative treatment (fast track) protocol for lung surgery and have conducted a pilot study in a prospective, randomized controlled manner to evaluate this program compared to conservative treatment.


   2. Methods
Top
 Abstract
 1. Introduction
 2. Methods
3. Results
 4. Discussion
 References
 
2.1 Study design
The study was designed as a monocentric randomized, controlled and prospective pilot study. The study protocol was approved by the local ethics committee and was conducted according to the principles of the Declaration of Helsinki. After given written informed consent patients were randomly assigned to the two treatment arms using a randomized block design prepared by the Department of Biometry, University of Ulm.

2.2 Inclusion/exclusion criteria
All patients that were admitted with suspected lung neoplasms and who had the indication of lung resection (wedge or anatomic resection) were eligible for the study. After given written informed consent patients were randomly assigned to either the conservative or the fast track patient management. Patients were excluded if one of the following conditions was given: withdrawal of informed consent, clinical signs of infection (fever, leukocytosis) on admission, pre-existing pneumonia, contraindications for thoracic epidural anesthesia (e.g. coagulopathy), or neuromuscular disorder that did not allow proper postoperative physiotherapy. Repeat lung resection or neo-adjuvant chemotherapy were no reasons for exclusion from the study.

2.3 Study endpoints
Primary study endpoints were pulmonary complications: (i) atelectasis; (ii) pneumonia; and (iii) prolonged air leak >7 days; atelectasis was diagnosed on chest-X ray and CT scan, respectively; diagnosis of pneumonia was confirmed if antibiotic medication was required on the basis of clinical and radiological signs of infection combined with elevated white cell count/raised CRP. Secondary endpoints were cardiovascular events and technical complications. Further parameters assessed in the postoperative course of patients were the need for postoperative mechanical ventilation, temperature at the end of the operation, length of stay (LOS) on intensive care unit (ICU) and day of discharge.

2.4 Table of randomization
Fifty-nine patients have been randomized in our study. One patient was excluded due to withdrawal of informed consent. Twenty-eight patients were assigned to the conservative and 30 to the fast track group. Due to the impossibility of inserting the epidural catheter and non-function, respectively three patients from the fast track group dropped out. Analysis was performed in an intention to treat (Fig. 1 ).


Figure 1
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  		Fig. 1. Randomization and outcomes. Fifty-nine patients were randomized of whom one patient withdrew consent. Twenty-eight patients were assigned to conservative, 30 to fast track treatment; in the fast track group three patients dropped out; EDA: epidural anesthesia.

 
2.5 Perioperative patient management
In both groups preoperative patient education (chest tube) was performed. Heat loss is usually prevented by administration of warm i.v. fluids and external heating using air heaters as well as in the preparation room and on the operative table. Major differences consisted in preoperative fasting and pain control.

2.6 Conservative treatment
Traditional perioperative management of patients undergoing lung resection in our institution consists of the following measurements: preoperative patient education, preoperative fasting for 6 h; pain control is usually achieved by application of intercostal nerve blockade intraoperatively using 5 ml of ropivacaine 0.75% and postoperative administration of i.v. opioids (piritramide) in a patient controlled manner (PCA). Apart from that patients receive medication with NSAIDs (diclophenac 75 mg twice daily + metamizole 1 g i.v. four times daily). Enteral feeding and ambulation start from the first postoperative day, i.v. fluids are restricted to 1000 ml/24 h.

2.7 Fast track regimen
The introduced fast track regimen includes preoperative patient education identical to the conservative management; preoperative fasting is limited to 2 h preoperatively and pain control was realized using a preoperatively inserted thoracic epidural catheter which was placed in the intervertebral spaces at the level between T5 and T9 with the loss-of-resistance technique. Patients received 10 ml of ropivacaine 1% preoperatively followed by the administration of ropivacaine 0.2% and sufentanil (2 µg/ml) postoperatively in a patient controlled manner (PCEA) accompanied by NSAIDs. Enteral feeding and ambulation started on the evening of the operation (Table 1 ).


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  		Table 1 Detailed overview of the conservative and fast track regimen
 
2.8 Statistical analysis
The primary analysis was conducted according to the intention to treat. For discrete variables absolute and relative frequencies are given. For other variables median values and range are applied. To calculate significances of morbidity/mortality and pulmonary complications in the treatment groups and the subgroups Fisher's exact test was used. A p-value <0.05 were regarded to be significant. Statistical analysis was performed in collaboration with the Department of Biometry using the computer program SigmaStat.

2.9 Patient characteristics
The two treatment groups were similar with respect to age, sex, underlying disease that caused admission to hospital, American Society of Anesthesiologists (ASA) score and surgical procedures that were performed. All surgical procedures were performed using an antero-lateral thoracotomy. Preoperative pulmonary function given as FEV1 was slightly decreased in the fast track group (n.s.). In the conservative group we had 19 patients with NSCLC compared to 25 patients in the fast track group. From these in both groups T2 stages were predominant; the number of T1 and T3 stages was similar. One patient in the conservative treatment group was operated on with suspected lung neoplasm that turned out to be a mesothelioma (Table 2 ).


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  		Table 2 Overview over patient characteristics
 

   3. Results
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
4. Discussion
 References
 
3.1 Ventilation, patient temperature, LOS on ICU, day of discharge
Table 3 shows our study results in terms of need for postoperative ventilation, patient temperature, length of stay on ICU and day of discharge. The majority of the patients were extubated in the OR. Only two patients in the conservative and one patient in the fast track group needed postoperative assisted ventilation (7% vs 4%; n.s.). Temperature at the end of the operation did not differ significantly. Median length of stay on ICU was comparable in both groups (1 day). Also the median day of discharge did not differ in both treatment groups (11 days).


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  		Table 3 Results in terms of postoperative ventilation, length of stay (LOS) on intensive care unit (ICU) and day of discharge
 
3.2 Morbidity and mortality
Results of parameters screened in the postoperative course of the patients are listed in Table 4 . We found pulmonary complications in 10/28 (36%) patients in the conservative treatment group and in 2/30 (7%) in the fast track treatment group (p = 0.009). In the conservative treatment group two patients experienced postoperative atelectasis of lung lobes as confirmed on CT scan and therefore required bronchoscopy; in the fast track group no patient showed signs of lung atelectasis. In terms of postoperative pneumonia, we had three patients in the conservative treatment group and no patient in the fast track group that needed antibiotic medication. Prolonged air leaks >7 days occurred in three patients in the conservative and in one patient in the fast track group. Pleural effusions as judged by ultrasound and chest X-ray with no need for intervention were seen in two patients in the conservative and one patient in the fast track group. Empyemas have not been documented during the observation period. With respect to cardiac events we had arrhythmias and signs of myocardial infarction/decompensation in two patients in the conservative and four patients in the fast track group. Reoperation was necessary in one patient in each group: one due to postoperative bleeding and one due to persistent air leak. Other complications such as urinary tract infection and renal insufficiency were seen in three patients altogether in both groups. In each group one patient died due to progression of the underlying malignant disease and myocardial infarction, respectively.


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  		Table 4 Postoperative complications and mortality in the postoperative course in the conservative and the fast track group
 
As for our primary study endpoint, the rate of pulmonary complications, fast track patients showed a significant reduction of these events 36% versus 7%, p = 0.009; the overall morbidity (any complication documented) did not significantly differ between the two groups: 46% versus 26%, p = 0.172. Mortality in both groups was comparable (4% vs 3%).

3.3 Subgroup analysis in patients with reduced FEV1 (<75% predicted value)
According to the British Thoracic Society [12] for lobectomies preoperative FEV1 > 1.5 l, for pneumonectomies > 2 l or FEV1 > 80% are safe lower limits. Vice versa patients with FEV1 below these limits are at risk for postoperative pulmonary complications. Therefore, we performed a subgroup analysis in patients with preoperative FEV1 < 75%.

3.3.1 Patient characteristics of the subgroup
Table 5 gives an overview of the subgroup of patients with reduced pulmonary capacity of FEV1 < 75% of predicted value. We had nine patients in the conservative and 13 patients in the fast track group meeting this criterion. As for age, sex, underlying disease, ASA score and surgical procedure performed no major differences were seen; median preoperative FEV1 was 60% in the conservative and 50% in the fast track group.


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  		Table 5 Overview of patient characteristics in the subgroup with FEV1 below 75% of predicted value
 
3.3.2 Postoperative complications in the subgroup
In the conservative group pulmonary complications occurred in 5/9 (56%) patients: atelectasis, pleural effusion and persistent air leak >7 days in one patient each, pneumonia in two patients; in the fast track group only one patient showed a prolonged air leak; cardiac events were noted in one patient in each group. In the fast track group one patient had to be reoperated on due to prolonged air leak. In summary pulmonary complications were significantly lower in the fast track group: 56% versus 8%, p = 0.023 (Table 6 ).


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  		Table 6 Subgroup analysis of patients with FEV1 < 75%
 

   4. Discussion
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
References
 
Pulmonary complications during the postoperative course continue to present a major source of morbidity and mortality for patients undergoing thoracotomy for different lung diseases. After major lung resections the incidence of postoperative pneumonia is about 25%, overall morbidity about 39% [4]. As by single interventions patients’ outcome does not seem to be improvable. Multimodal therapeutic approaches, so called fast track programs, have been implemented to reduce morbidity and mortality after major surgical procedures [1]. As for major lung surgery no randomized prospective trials exist to evaluate such fast track programs. In our pilot study we have modified and adopted various techniques from fast track programs in other surgical specialties in order to introduce and evaluate a fast track program for lung surgery.

We included patients with the indication for operation due to suspected lung neoplasm. Both groups were comparable with respect to sex, age, preoperative FEV1, ASA score and surgical procedures performed.

In the preoperative period patients in both groups were educated about postoperative care and the use of the chest tube as patient education of postoperative care plan can reduce anxiety and enhance postsurgical recovery [13]. In terms of preoperative fasting that traditionally consists of a 6 h period of nothing-by-mouth it has been shown that preoperative carbohydrate drink may reduce postoperative endocrine responses [14]. As a consequence fast track patients were allowed clear drinks until 2 h preoperative.

Another fact determining postoperative morbidity is intraoperative heat loss [15]. Hence in our department heat loss in patients undergoing major surgical procedures is usually prevented using external heating by air heaters on the operative table and the administration of warm i.v. fluids. In the fast track protocol warming of the OR to 22 °C was additionally realized in order to avoid hypothermia in our patients. However, warming up the OR did not result in significant improvement of the patients’ core temperature (35.7 °C vs 35.6 °C).

Surgical procedures present stress for the patient and induce organ dysfunction by release of various hormones (cortisol, catecholamines) and cytokines that can be diminished by blocking the afferent neural stimulus with epidural anesthesia [16]. To date regional anesthesia is regarded to be the ideal technique available to attenuate endocrine metabolic responses with an extended effect on postoperative analgesia [17]. By this means postoperative morbidity as compared with general anesthesia could be decreased [18]. Video-assisted thoracic surgery as a minimal invasive approach to reduce surgical stress is feasible in lung lobectomies, but there is only thin evidence about its impact on morbidity and mortality [8].

Pain management post-thoracotomy traditionally consists of intravenous narcotics [19]. Other approaches aim at a cryoanalgesia [20] and muscle sparing mini thoracotomy [11]. In the treatment of post-thoracotomy pain thoracic epidural anesthesia appears to be superior to patient controlled intravenous opioid-based analgesia [21]. We therefore used thoracic epidural analgesia in our fast track regimen for both purposes; intraoperative stress reduction and postoperative pain control. The epidural catheter was inserted preoperatively and used postoperatively in a patient controlled manner (PCEA); it was removed as soon as pain relief could be achieved by i.v. opioids and NSAIDs alone, usually after 48–72 h. A limitation of this technique may be that insertion is not possible or the catheter dislocates; in our series in three patients in the fast track group (10%). Nevertheless as most complications in lung surgery are related to pain and inability to perform proper physiotherapy we support the use of epidural anesthesia as patients feel more satisfactory in terms of pain relief as judged by VAS [22].

As for the primary endpoint of our study, postoperative pulmonary complications (atelectasis, pneumonia, prolonged air leak and pleural effusion), we found a significant advantage for patients in the fast track group: 36% versus 7% (p = 0.009); After thoracotomy due to lung cancer, pulmonary complications occur in up to 39% and continue to present a major source of morbidity and mortality [4,6]. Nosocomial pneumonia after thoracotomy represents an important risk factor for morbidity and mortality and its reported incidence ranges from 15 to 25% depending on preoperative pulmonary function and surgical procedure [6,23]. In our investigation pneumonia was confirmed in 11% in the conservative and in no patient in the fast track group. Prolonged air leaks following lobectomy or wedge resection carry a low mortality rate, but result in prolonged hospitalization and its incidence ranges from 4% to 26% [24]; in our series prolonged air leaks >7days were seen in three patients in the conservative group and one patient in the fast track group. Cardiovascular events, frequency of reoperation and other minor complications did not differ between the two groups. Mortality rate in our series was 4% versus 3% (n.s.) that is in accordance with other groups who report mortality rates about 6% depending on the extent of surgery and on pulmonary function [25].

According to the guidelines of the British Thoracic Society with data from >2000 patients a preoperative FEV1 > 1.5 l for lobectomies and >2 l for pneumonectomies are safe lower limits [12]. Patients with preoperative FEV1 below these limits are regarded to be at high risk for respiratory failure after lung resections. In our series we had 22 patients with FEV1 < 75% (9 conservative treatment, 13 fast track treatment). The post-hoc analysis of this subgroup revealed 56% pulmonary complications in the conservative group and 8% in the fast track group (p = 0.02).

Taking all results together our optimized perioperative patient (fast track) management represents a clear improvement in patients’ outcome after lung surgery. Other groups report complication rates after lung surgery between 25% and 40% [6,25]. In our small series the rate of pulmonary complications in patients undergoing lung resections could be reduced to 7% by using a fast track regimen. We feel a key factor contributing to patients’ good outcome is the use of regional anesthetic techniques (patient controlled epidural anesthesia). By this means the surgical stress response is diminished and an optimized pain relief can be achieved; the patient is able to perform proper physiotherapy and early ambulation. This leads to rapid restoration of physical activity and hence reduces respiratory failure caused by inactivity. Moreover postoperative convalescence, which depends upon pain, fatigue and special surgical factors, can be diminished.

In summary our study is to our knowledge, the first prospective randomized trial to introduce and evaluate a fast track recovery program after lung surgery. Implementation of this optimized perioperative patient management may reduce the incidence of pulmonary complications and the overall morbidity after lung resections. As pulmonary complications still represent a life-threatening situation during the postoperative course particularly in patients with reduced FEV1 we support the use of an optimized patient care management as an effective preventive strategy to further decrease morbidity and mortality. However, due to the relatively small number of our patients further multicentric studies with more patients are warranted to confirm our preliminary encouraging results in our pilot study.


   References
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 References
 

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