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*Respiratory Therapy Unit of the Division of Surgical Intensive Care,
Division of Surgical Intensive Care, Department of Anaesthesiology, Pharmacology and Surgical Intensive Care, Geneva University Hospital, Geneva, Switzerland
Address correspondence and reprint requests to Paolo Merlani, MD, Division des Soins Intensifs de Chirurgie, Département APSIC, Rue Micheli-du-Crest 24, 1211 Geneva 14, Switzerland. Address e-mail to paolo.merlani{at}hcuge.ch
| Abstract |
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2 after cardiac surgery were randomly assigned to receive either CPAP or NIPSV four times a day for 30 min. Positive end-expiratory pressure was set at 5 cm H2O in both groups. In the NIPSV group, pressure support was set to provide a tidal volume of 810 mL/kg. At SICU discharge, we observed an improvement of the Radiological Atelectasis Score in 60% of the patients with NIPSV versus 40% of those receiving CPAP (P = 0.02). There was no difference in oxygenation (PaO2/fraction of inspired oxygen at SICU discharge: 280 ± 38 in the CPAP group versus 301 ± 40 in the NIPSV group), pulmonary function tests, or length of stay. Minor complications, such as gastric distensions, were similar in the two groups. NIPSV was superior to CPAP regarding the improvement of atelectasis based on radiological score but did not confer any additional clinical benefit, raising the question of its usefulness for altering outcome. IMPLICATIONS: This prospective, randomized, controlled study analyzing the treatment for atelectasis after cardiac surgery showed that noninvasive pressure support ventilation was superior to continuous positive airway pressure for improving atelectasis based on radiological score but did not confer any additional benefit, thus raising the question of its clinical usefulness.
| Introduction |
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Noninvasive pressure support ventilation (NIPSV) is a recognized treatment for acute hypercapnic and hypoxemic acute respiratory failure (1113). There is some evidence that NIPSV improves oxygenation in postoperative nonhypercapnic patients, but NIPSV has not been studied for treating postoperative atelectasis (10,14,15). In proportion to the level of supplemental pressure support applied, it increases tidal volume, decreases respiratory rate, and improves gas exchange and diaphragmatic activity (16,17). Pressure support is usually set to achieve a tidal volume of 810 mL/kg (12,18).
We hypothesized that NIPSV, by the adjunction of a pressure support to the usual CPAP, may be more effective for treating postoperative atelectasis after cardiac surgery. We tested this hypothesis in a prospective, randomized, single-blind, controlled study.
| Methods |
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2 after tracheal extubation were included. The Radiological Atelectasis Score was defined according to Richter et al. (19): 0, clear lung field; 1, platelike atelectasis or slight infiltration; 2, partial atelectasis; 3, lobar atelectasis; and 4, bilateral lobar atelectasis. The exclusion criteria were pneumothorax, facial lesions, altered mental status, hemodynamic instability (defined as mean arterial blood pressure <60 mm Hg or a need for vasopressors, electrocardiograph instability with evidence of ischemia, or significant ventricular arrhythmia), planned secondary operation or transfer to another unit within 8 h after the diagnosis of atelectasis, more respiratory physiotherapy sessions than permitted in the study protocol requested by the clinician in charge or patients needing a permanent application of positive-pressure ventilation by mask to maintain a percutaneous oxygen saturation >90% (identified as refractory hypoxemia), or patient refusal.
Before the study inclusion, all patients admitted to the SICU after cardiac surgery were tracheally intubated and received synchronized intermittent mandatory ventilation with a tidal volume of 810 mL/kg body weight (respiratory rate, 12 breaths/min; inspiratory/expiratory time ratio, 1:2; PEEP, 5 cm H2O). Every ventilator was equipped with a heat and moisture exchanger. The respiratory rate and fraction of inspired oxygen (FIO2) were adjusted according to arterial blood gas analysis. As soon as the patient showed spontaneous breathing, the pressure support was reduced to 10 cm H2O, and the trachea was extubated according to the local protocol (percutaneous oxygen saturation >90% at an FIO2 of
0.4; pH >7.34; respiratory rate
35 breaths/min with pressure support of
10 cm H2O; PEEP
5 cm H2O; patient awake; intact swallowing reflex; stable hemodynamics). When extubated, every patient received prophylactic respiratory physiotherapy consisting of CPAP at PEEP 5 cm H2O four times a day for 15 min and a coughing session if necessary. Patients who developed a Radiological Atelectasis Score
2 were included in the study after informed consent and were randomly assigned to either the CPAP or the NIPSV group. Patients were blinded to randomization because an identical face mask (Vital Signs Inc., Totowa, NJ) held in place by head straps was applied for both therapeutic groups.
CPAP was provided by a gas mixer with an adjustable flow (Mov 60 O2/Air®; LNI Industry, Geneva, Switzerland), which was connected to a 5-L bag and a PEEP valve (Ambu, Copenhagen, Denmark) (20). The settings were flow rate 30 L/min, PEEP 5 cm H2O, and FIO2 adjusted to achieve a percutaneous oxygen saturation >90%.
NIPSV was performed with Veolar FT® and Galileo® (Hamilton Inc., Reno, NV), Servo 300® (Siemens, Solna, Sweden), and Evita 4® (Dräger, Lübeck, Germany) in a spontaneous mode with a pressure support level adjusted to achieve a tidal volume of 810 mL/kg. Maximal pressure was delivered at 30 cm H2O, PEEP was 5 cm H2O, the minimal trigger flow was selected, and FIO2 was adjusted to achieve a percutaneous oxygen saturation >90%.
In both groups, patients underwent 30-min sessions four times a dayat 5:00 AM, 10:00 AM, 4:00 PM, and 10:00 PMin a semirecumbent position with the head at
45° to minimize the risk of gastric distention and/or aspiration. Humidification of inspired gases was performed by a heat and moisture exchanger. Twice a day, two respiratory therapists assessed patients for airway secretions. When these were present, the therapists performed an assisted coughing session consisting of a forced inspiration and expiration repeated three times, followed by a cough. The physiotherapist held the patients chest during the cough and performed a nasotracheal suction if there was no expectoration after three sessions. Patients were mobilized as early as possible to an arm chair for at least 1 h daily. Postoperative pain management was ensured by paracetamol (acetaminophen) by mouth 1 g every 6 h and by morphine IV to achieve a visual analog scale (VAS) score
3. VAS
3 was required before each CPAP or NIPSV session.
The preoperative values of arterial blood gas analyses, the vital capacity (VC) and the forced expiratory volume in 1 s (FEV1), age, sex, weight, and history of respiratory disease and smoking were recorded from the patients chart after randomization. The type of cardiac surgery and the duration of cardiopulmonary bypass were noted. Postoperative data included the simplified acute physiologic score version II (21), the duration of mechanical ventilation and the highest PEEP used during mechanical ventilation, the day of the first postoperative mobilization, the daily duration of the mobilization to an armchair, the day of thoracic tube removal, the SICU and hospital length of stay and mortality, and the readmission to the SICU.
The following assessments were performed at inclusion in the study (Time 0; T0) and every day (T1, T2, T3,...Tn) until the day of discharge (time of discharge; TD). Chest radiographs, performed in a semirecumbent position in bed or in the standing position whenever possible, were evaluated by two physicians certified in intensive care independent of the study and blinded to randomization. We assessed by Cohens
test the intrarater and the interrater variability of the Radiological Atelectasis Score between the 2 physicians in the first 20 patients. In all chest radiographs, the differences in the Radiological Atelectasis Score rating were resolved by discussion between the physicians. Arterial blood gas tension was measured (Stat Profile Ultra C®; Nova Biomedical, Waltham) with the patient breathing room air for at least 10 min (13) at 9:00 AM, 3 h 30 min after the last CPAP or NIPSV session. If the percutaneous oxygen saturation decreased to less than 88% within the 10-min interval, arterial blood gas values were measured after 10 min on an oxygen mask at an FIO2 of 0.4. At TD, arterial blood gas analyses were all measured from patients breathing room air. VC and FEV1 were measured every day at 9:00 AM by a spirometer (Micro Plus®; Micro Medical Ltd., Rochester, UK) when the patient was sitting in bed. The best result of two tests was recorded. The cumulative fluid balance, the type of adverse events caused by CPAP and NIPSV, and the highest level of pressure support given by NIPSV were noted. The patients were considered hypersecretive when they needed additional chest physiotherapy, such as induced cough sessions or nasotracheal suctioning. The number of sessions per patient was recorded. Daily, the maximal pain intensity and the pain intensity before each CPAP or NIPSV session were assessed by a 10-cm VAS with a range of 0 to 10, anchored by "no pain" at one end and by "worst possible pain" at the other end. At discharge, the perceived degree of comfort related to CPAP or NIPSV were evaluated by a 10-cm VAS with a range of 010 ("very comfortable" = 0 and "very uncomfortable" = 10) (22). Patients were discharged from the SICU if they showed a percutaneous oxygen saturation >90% with an FIO2
0.35, were hemodynamically stable without IV vasopressors, and had no major cardiac arrhythmia for the last 24 h. Patients were discharged only after removal of the thoracic tube. The study protocol ended at the time of SICU discharge because NIPSV cannot be performed on a general ward, according to institutional regulations. The patients SICU stay was not prolonged for study purposes. The decision to discharge the patient from the hospital was left to the discretion of the cardiovascular surgeon in charge of the patient, independent from the study team.
To achieve an expected improvement of the Radiological Atelectasis Score from 50% to 75%, the ß test with an
of 0.05 and 80% power required 66 patients in each group. One-hundred-fifty patients were randomized by a computer-generated randomization table with concealed, opaque envelopes. The two groups were compared in an intention-to-treat analysis. Demographic and physiological characteristics were compared by Students t-test for continuous and Fishers exact test for categorical variables. Nonparametric or nonnormally distributed data were compared by Mann-Whitney U-test. Multiple comparisons were performed by one-way analysis of variance with Bonferronis correction. We performed an analysis of covariance, with therapy (NIPSV versus CPAP) as the main predictor of interest, adjusting for Radiological Atelectasis Score at T0 treated as a continuous variable to increase precision. The Radiological Atelectasis Score at TD was the response variable. All tests were two-tailed, and a P value <0.05 was considered statistically significant. Results are expressed as mean ± SD if not specified otherwise.
| Results |
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test. At T0, an important decrease of VC and FEV1 occurred to a similar extent in both groups compared with preoperative values and persisted at TD (Table 2).
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Radiological Atelectasis Score = Radiological Atelectasis Score at T0 Radiological Atelectasis Score at TD) showed a statistically significant improvement in favor of the NIPSV group (P = 0.02) (Table 3). The Radiological Atelectasis Score decreased in 30 (40%) patients with CPAP, compared with 45 (60%) patients with NIPSV (P = 0.02). The Radiological Atelectasis Score even worsened in 8 (11%) patients with CPAP, compared with 1 (1%) patient with NIPSV (P = 0.03) (Fig. 2, Table 3). The difference in Radiological Atelectasis Score at TD comparing NIPSV with CPAP was 0.26 (95% confidence interval, 0.47 to 0.05), with a lower score among patients assigned to the NIPSV group (P = 0.01), adjusting for Radiological Atelectasis Score at T0. The Radiological Atelectasis Score at T0 was highly predictive of the score at discharge (coefficient, 0.6; 95% confidence interval, 0.390.82). At TD, pH, PaCO2, PaO2/FIO2, VC, and FEV1 were similar in the two groups (Table 2). Patients of the two groups received an equivalent number of treatment sessions (Table 4). The degree of comfort was similar in both groups (Table 4). No major complication, such as facial lesion due to the mask or pneumothorax induced by the intervention, was observed during the study. Minor complica-tions, such as radiological gastric distention or nau-sea, were equally distributed between the CPAP group (19 [25%]) and the NIPSV group (12 [16%]). No bronchoscopy was performed for treatment of atelectasis in any patient.
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| Discussion |
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In the literature, studies on postoperative atelectasis after cardiac surgery do not clearly separate the effect of the prophylactic regimen to prevent atelectasis fromthe effect of the treatment of atelectasis. This difference is important in everyday clinical practice, and several authors have emphasized the need for studies analyzing separately the preventive and therapeutic regimens (8,23). This study is the first to analyze the therapeutic effect of NIPSV on atelectasis after cardiac surgery compared with CPAP. CPAP is often used for the prevention of postoperative atelectasis after cardiac surgery (2,10), but its efficacy in atelectasis treatment was evoked only after abdominal surgery: in 10 (83%) of 12 patients, Andersen et al. (9) showed a partial resolution of atelectasis after CPAP (PEEP, 15 cm H2O for
2 min every hour). In our study, the CPAP group showed improvement in only 30 (40%) of the 75 patients. This difference is not surprising because of the different patient populations: the risk factors for the development and evolution of postoperative atelectasis are linked with the site and type of surgery (24,25).
Despite the radiological improvement of atelectasis, 149 patients left our SICU with persistent atelectasis. Furthermore, we could not find a difference between groups regarding oxygenation and pulmonary function that remained below normal limits in both groups at SICU discharge. This is consistent with the study of Ricksten et al. (26), who demonstrated that only the resolution and not the reduction of the radiological size of atelectasis can induce significant changes of oxygenation and pulmonary functions.
NIPSV was as safe and comfortable as CPAP. These results on the safety and comfort of NIPSV are also consistent with other publications regarding NIPSV and acute respiratory failure (11,12). No major complication was noted, and few minor side effects were observed in both groups.
The SICU or hospital length of stay and mortality did not differ between groups. However, our study was not designed or powered to address questionsabout the clinical outcome of the two therapeutic approaches.
Our study has some limitations. The first regards the large number of patients who met exclusion criteria. Although this created a more homogeneous study group, some excluded patients, particularly those with refractory hypoxemia, could have benefited more from NIPSV. The second limitation was the short duration of the treatment of both groups because of the transfer of patients to the wards. Because of the restricted availability of SICU beds and for ethical reasons, the SICU stay was not to be prolonged because of the study. This could explain the persistence of radiological atelectasis in most of our patients, as in other studies (27). We cannot exclude that the pursuit of treatment by NIPSV after three days could have caused a further increase in resolution of atelectasis associated with an improvement of oxygenation or pulmonary function. Third, referring to previous studies, we chose only 5 cm H2O of PEEP (4,10), because our study sought to analyze the effect of the additional pressure support at the same level of PEEP in both groups. Therefore, our study cannot exclude that higher levels of PEEP may have improved the results in the CPAP or NIPSV group.
Finally, the application of NIPSV is considered time consuming for nurses and may require more resources (12,28). This aspect of the comparison of the two methods was not addressed in our study. However, present preoccupations about cost effectiveness and costs of health care suggest that strong evidence of benefit for patients should be present whenever a new therapeutical approach is proposed.
In conclusion, we showed in this large, prospective, randomized, single-blind, controlled study that NIPSV is superior to CPAP regarding the improvement of the Radiological Atelectasis Score after cardiac surgery. The persistence of atelectasis at SICU discharge and the lack of other clinical benefits (oxygenation, pulmonary function, and length of stay) raise the questions of the clinical usefulness and the duration of any treatment. Furthermore, NIPSV does not appear to be less resource consuming. Thus, we cannot encourage the use of NIPSV for the treatment of atelectasis after cardiac surgery.
| Acknowledgments |
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| Footnotes |
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| References |
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