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* From the Division of Intensive Care (Mr. Pasquina and Mr. Granier) and the Division of Anesthesiology (Drs. Tramèr and Walder), Department APSI (Anesthésie, Pharmacologie et Soins Intensifs), Geneva University Hospitals, Geneva, Switzerland.
Correspondence to: Patrick Pasquina, Division of Intensive Care, Geneva University Hospitals, 1211 Geneva 14, Switzerland; e-mail: Patrick.Pasquina{at}hcuge.ch
Abstract
Objectives: To examine the efficacy of respiratory physiotherapy for prevention of pulmonary complications after abdominal surgery.
Methods: We searched in databases and bibliographies for articles in all languages through November 2005. Randomized trials were included if they investigated prophylactic respiratory physiotherapy and pulmonary outcomes, and if the follow-up was at least 2 days. Efficacy data were expressed as risk differences (RDs) and number needed to treat (NNT), with 95% confidence intervals (CIs).
Results: Thirty-five trials tested respiratory physiotherapy treatments. Of 13 trials with a "no intervention" control group, 9 studies (n = 883) did not report on significant differences, and 4 studies (n = 528) did: in 1 study, the incidence of pneumonia was decreased from 37.3 to 13.7% with deep breathing, directed cough, and postural drainage (RD, 23.6%; 95% CI, 7 to 40%; NNT, 4.3; 95% CI, 2.5 to 14); in 1 study, the incidence of atelectasis was decreased from 39 to 15% with deep breathing and directed cough (RD, 24%; 95% CI, 5 to 43%; NNT, 4.2; 95% CI, 2.4 to 18); in 1 study, the incidence of atelectasis was decreased from 77 to 59% with deep breathing, directed cough, and postural drainage (RD, 18%; 95% CI, 5 to 31%; NNT, 5.6; 95% CI, 3.3 to 19); in 1 study, the incidence of unspecified pulmonary complications was decreased from 47.7% to 21.4 to 22.2% with intermittent positive pressure breathing, or incentive spirometry, or deep breathing with directed cough (RD, 25.5 to 26.3%; NNT, 3.8 to 3.9). Twenty-two trials (n = 2,734) compared physiotherapy treatments without no intervention control subjects; no conclusions could be drawn.
Conclusions: There are only a few trials that support the usefulness of prophylactic respiratory physiotherapy. The routine use of respiratory physiotherapy after abdominal surgery does not seem to be justified.
Key Words: abdominal surgery atelectasis continuous positive airway pressure incentive spirometry intermittent positive pressure breathing metaanalysis physical therapy pneumonia respiratory physiotherapy
More than 4 million abdominal surgeries are performed in the United States every year.1 Patients undergoing abdominal surgery are at increased risk for pulmonary complications postoperatively.2 Postoperative pulmonary complications increase hospital morbidity, prolong hospital stay, and contribute to additional health-care costs.3
Postoperative pulmonary complications seem to be related to the disruption of the normal activity of respiratory muscles, a phenomenon that starts at induction of anesthesia and continues into the postoperative period.4 Anesthetics, phrenic nerve dysfunction, and surgical trauma all impair the function of respiratory muscles after surgery. These mechanisms lead to a decrease in functional residual and vital capacity for many days, and subsequently to atelectasis. In an animal study,5 atelectasis was shown to promote bacterial growth due to reduced function of alveolar macrophage and reduced functional surfactant, explaining the risk of pneumonia.
Postoperative chest physiotherapy was implemented in the beginning of the 20th century; deep breathing exercise was one of the first methods.6 Subsequently, a variety of manual treatments including percussion, clapping, vibration, or shaking were developed to improve bronchial drainage. More recently, mechanical breathing devices such as incentive spirometry (IS), blow bottles, intermittent positive pressure breathing (IPPB), and continuous positive airway pressure (CPAP) were introduced into clinical practice. In 1994, a metaanalysis7 concluded that prophylactic incentive spirometry and deep-breathing exercises were beneficial after abdominal surgery; however, an amalgamation of a variety of different pulmonary end points (for instance, atelectasis, pneumonia, or bronchitis) was analyzed. Thus, the clinical relevance of this positive finding remained unclear. Subsequently, two further metaanalyses89 studied the impact of prophylactic respiratory physiotherapy on more specific postoperative pulmonary complications, ie, atelectasis or pneumonia. Overend et al8 concluded that incentive spirometry was of no use after cardiac or abdominal surgery, and we were unable to find any evidence that a variety of physiotherapy treatments were beneficial after cardiac surgery.9
Some methods of respiratory physiotherapy are labor intensive and costly, and some may even induce specific adverse effects.9 To justify the routine use of prophylactic respiratory physiotherapy after major surgery, we need to be confident that the efficacy is worthwhile and that there is a minimal likelihood of harm. Discrepancies in the conclusions of previous metaanalyses may be explained by differences in the selection of analyzed trials and by variations in the choice of analyzed end points. We set out to review the evidence that prophylactic respiratory physiotherapy prevented pulmonary complications after abdominal surgery.
Materials and Methods
As in a previous, similar analysis,9 we took two pre hoc decisions to ensure that our conclusions were based on both clinically relevant and methodologically valid data. First, in the context of postoperative pulmonary complications, a reduction of pneumonia was of primary interest. Second, in the absence of a "gold standard" intervention, a randomized comparison between a physiotherapy method and a "no intervention" control was the most valid study design to establish the relative efficacy of physiotherapy.9
Studies were identified using MEDLINE, EMBASE, CINAHL, and the Cochrane Controlled Trials Register. The search strategy included the free-text terms physical therapy, respiratory therapy, breathing exercise, chest physiotherapy, continuous positive airway pressure, incentive spirometry, intermittent positive pressure breathing, noninvasive positive pressure ventilation, bilevel positive airway pressure ventilation, blow bottles, positive expiratory pressure, postural drainage, abdominal surgery, cholecystectomy, gastrectomy, pancreas, colectomy, laparotomy, biliary tract, gastric, and random. The last electronic search was in November 2005. Reference lists from retrieved reports and from review articles781011 were reviewed to identify additional studies. Articles in all languages were considered. We contacted the original investigators by letter and asked for supplementary data related to their study, and for unpublished data.
Criteria for Inclusion
We included full reports of randomized trials of patients undergoing open abdominal surgery. As in a previous similar analysis,9 we did not consider trials with inadequate randomization methods (for instance, group assignment according to patients date of birth, or alternate). Relevant trials had to compare any technique of prophylactic respiratory physiotherapy (active intervention) with no intervention (inactive control) or with another method of respiratory physiotherapy (active control). Studies that tested therapeutic physiotherapy to treat pulmonary complications were not considered. Trials had to report on one of five end points: atelectasis, pneumonia, postoperative pulmonary complications, oxygenation (PaO2/fraction of inspired oxygen [FIO2] ratio), and vital capacity. Trials were included if they reported on an observation period of at least 2 days. If end points were reported at different time points, we considered the longest observation period. Information on adverse effects that could be attributed to physiotherapy was also extracted.
Assessment of Quality of Data Reporting
Data abstraction was carried out by one investigator and independently reviewed by two others. We assessed for each included study the method of randomization and of concealment of treatment allocation, the degree of blinding, and completeness of follow-up.12 We assumed that in this specific clinical setting, patient and care givers could not be blinded. Extracted data and quality scores were compared; in case of disagreement, consensus was reached by discussion.
Data Analysis
We recalculated dichotomous data on absence or presence of pulmonary complications as risk differences (RDs) with 95% confidence intervals (CIs).13 When the 95% CI around the RD excluded zero, we assumed that the difference between groups was statistically significant. For statistically significant results, the number needed to treat (NNT), the reciprocal of the RD, was computed as an estimate of the clinical relevance of a treatment effect.14 Event rate scatters were used to explore the variability in the incidence of outcomes.
Results
Trial Characteristics
We screened 437 reports; 62 were considered for inclusion, but 27 were subsequently excluded (Fig 1
). There was one redundancy unit15; we regarded the more detailed article as the original report16 and excluded the duplicate.17 We eventually analyzed data from 35 randomized trials with data on 4,145 adult patients (Table 1
).1618192021222324252627282930313233343536373839404142434445464748495051 Trials came from 12 countries and were published between 1952 and 2005. Six authors23243233354246 responded to our inquiry; all provided supplementary information that could be used for analysis. Of the 14 trials that were included in the systematic review by Thomas and McIntosh,7 we included 11 trials16192226273641434748 but rejected 3 trials (2 used a pseudorandomization,5253 and 1 was published as an abstract only54). Average group size was 51 patients (range, 8 to 445). Eleven trials (31%) described an adequate method of randomization; in 5 trials (14%), treatment allocation was concealed; in 16 trials (46%), observers were blinded; and in 13 trials (37%), follow-up of patients was complete. A large variety of physiotherapy treatments and combinations thereof were tested; they were administered for a period of 1 to 9 days (average, 4 days). Observation periods were 2 to 15 days (average, 5 days).
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Adverse Effects
In two trials,3035 3 of 20 patients (15%) and 4 of 14 patients (29%), respectively, did not tolerate bilevel positive airway pressure due to discomfort. In one study,20 9 of 99 patients (9%) did not tolerate CPAP for > 12 h due to claustrophobia, and 4 of 99 patients (4%) had superficial nose ulcers.20 Abdominal distension occurred in 8 of 45 patients (18%) treated with IPPB.22 Finally, in one study,32 an incision hernia developed in 1 of 445 patients during chest physiotherapy. Twenty-six trials1618192125262728293133343637383940414344454748495051 did not mention any adverse effects, and 4 trials23244246 reported that none had occurred.
Conclusions of the Original Investigators
Authors of 4 of the 13 trials with no intervention control subjects concluded that prophylactic respiratory physiotherapy after abdominal surgery was useful; 1 trial each reported on a significant effect on atelectasis,2451 pneumonia,43 or unspecified pulmonary complications.22 Authors of 5 of the 22 active-controlled trials2630353946 concluded that one of the tested interventions was superior.
Discussion
Six of 13 trials162024424348 with a no intervention control group, the most valid trial design in this context, reported on the clinically most relevant end point, pneumonia. Only one of these trials43 showed a beneficial effect of physiotherapy on pneumonia. In that trial, the incidence of pneumonia in control subjects was extraordinarily high, challenging external validity of these data. Thus, the usefulness of prophylactic respiratory physiotherapy for the prevention of clinically relevant postoperative pulmonary complications after abdominal surgery remains unproven.
Most investigators preferred to report on vital capacity, PaO2/FIO2 ratios, atelectasis, or unspecified pulmonary complications. The significance of vital capacity and PaO2/FIO2 ratios are unclear; they may be regarded as surrogate end points, and there was actually no evidence of any improvement in these parameters with any of the tested physiotherapy treatments. The main problem with the end points "atelectasis" or "unspecified pulmonary complications" was the lack of a clear and universally accepted definition. And, as for vital capacity and PaO2/FIO2 ratios, there was uncertainty about the clinical relevance of these outcomes. For instance, "unspecified pulmonary complications" is a composite end point that includes diverse pathologies such as bronchitis, pneumonia, or atelectasis. Perhaps as a consequence of the variability in definitions of unspecified pulmonary complications, control event rates varied widely, ranging from 0% to almost 50%. Composite outcomes are appropriate only when the individual symptoms are well defined, when the components are of equal importance, and occur with similar frequencies, and when the active intervention leads to a similar relative risk reduction of all components.55 This is not the case for unspecified pulmonary complications. A metaanalysis7 reported a positive impact of prophylactic respiratory physiotherapy after abdominal surgery; interestingly, that favorable result was based exclusively on the analysis of unspecified pulmonary complications.
Our analysis has some limitations; most are related to weaknesses in the original studies. For instance, these trials were of limited methodologic quality; in less than half, observers were blinded; one third only reported on details of randomization and follow-up; and in a minority, treatment allocation was concealed. One inherent problem of physiotherapy trials is that the observer only can be blinded. We do not know whether the trials were badly designed or the data inadequately reported; most were published before the first Consolidated Standards of Reporting Trials statement.56 The problem is that trials of low methodologic quality may exaggerate estimates of efficacy.57 Many trials were of limited size. Small trial size may partly explain the variability in event rates. Also, small trials may be associated with low statistical power to detect statistically significant effects, even if true effects exist. Moreover, small trials are less likely to identify rare events, for instance, intervention-related adverse effects. Twenty-four of the 31 trials did not mention any adverse effects; however, not reporting of adverse effects does not mean that none had occurred. Most adverse effects were minor and we may assume that they are preventable through adequate handling of devices and appropriate training of chest therapists. Yet, the combination of potential for harm and doubtful efficacy further challenges the usefulness of routine prophylactic respiratory physiotherapy in these patients. Finally, as in similar previous analyses,9 a large variety of physiotherapy regimens were tested. This variability suggests that there is no consensus among physiotherapists on how to use these therapies and of what the "gold standard" intervention consists. In the absence of a "gold standard," trials should be designed to include a placebo group or, in this case, a no intervention control group.58 A minority only of the retrieved trials fulfilled that criterion. Finally, we had to assume that patients were treated in upright position and that they were mobilized, although this was not specified in the original trials. The necessary information to perform subgroup analyses to estimate the impact of such measurements on the efficacy of physiotherapy treatments was lacking.
What are the implications of this analysis? There are clinical settings, in which the usefulness of respiratory physiotherapy is based on strong evidence, for instance, therapeutic noninvasive positive pressure ventilation in patients with acute exacerbations of severe COPD,5960 pulmonary rehabilitation in patients with COPD,6162 chest physical therapy in patients with cystic fibrosis,63 or CPAP for the treatment of postoperative hypoxemia.64 Yet, considering the available evidence, routine use of prophylactic respiratory physiotherapy in patients after abdominal surgery does not seem to be justified. These trials were published between 1952 and 2005, they tested a large variety of physiotherapy treatments after different abdominal surgeries, and the majority of the studies were of only limited methodologic quality. It is, therefore, difficult to draw specific conclusions. For deep breathing with directed cough, the only method that showed some efficacy, we have to assume that the positive results were biased by trials that reported on very high control event rates or end points with doubtful clinical relevance.
The agenda is one of further research rather than of clinical recommendations. With > 4 million abdominal surgeries performed each year in the United States alone,1 it is of economic importance whether a labor-intensive and thus costly intervention with doubtful efficacy is routinely performed. Thus, the usefulness of prophylactic respiratory physiotherapy after abdominal surgery needs to be established in valid clinical trials before this intervention can be recommended for routine use. To avoid methodologic pitfalls in future studies, some issues that have been identified through this systematic review need to be addressed. All patients randomized to the experimental group should be treated with an identical technique of physiotherapy, including similar frequency and duration, and administered by trained physiotherapists. In all patients, further procedures, such as analgesia or mobilization, should also be identical. Trials should be of reasonable size to overcome random variations, and to identify with confidence small but clinically relevant benefits and rare adverse effects. Perhaps the most important potential benefit of respiratory physiotherapy, both from a clinical and the patients point of view, is the prevention of pneumonia. This end point needs a clear definition; the most appropriate in the context of nosocomial pneumonia may be from the Centers for Disease Control and Prevention.65 When ever feasible, assessments should be done by observers who are unaware of treatment allocation. The observation period should be expanded until hospital discharge. Length of stay (in the ICU and in the hospital) has important implications for costs; these data should be reported. Pulmonary high-risk patients need to be included in future trials. Risk scores, such as the multifactorial risk index for predicting postoperative respiratory failure in patients undergoing major noncardiac surgery,6667 may be used to stratify patients to those who are most likely to profit from prophylactic respiratory physiotherapy.
Footnotes
Abbreviations: CI = confidence interval; CPAP = continuous positive airway pressure; FIO2 = fraction of inspired oxygen; IPPB = intermittent positive pressure breathing; IS = incentive spirometry; NNT = number needed to treat; RD = risk difference
Mr. Pasquina initiated, designed, and organized the study, searched trials, and extracted data. Dr. Tramèr designed the study and cross-checked extracted data. Mr. Granier cross-checked extracted data. Dr. Walder initiated and designed the study and cross-checked extracted data. All authors participated in interpreting the results of the trials and in writing the article.
Received for publication August 25, 2005. Accepted for publication February 2, 2006.
References
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