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The effect of immediate postoperative Boussignac CPAP on adverse pulmonary events after thoracic surgery

A multicentre, randomised controlled trial

Puente-Maestú, Luis; López, Eloísa; Sayas, Javier; Alday, Enrique; Planas, Antonio; Parise, Diego J.; Martínez-Borja, Marcos; Garutti, Ignacio; on behalf of the PI12/02734 study group

Author Information
European Journal of Anaesthesiology: February 2021 - Volume 38 - Issue 2 - p 164-170
doi: 10.1097/EJA.0000000000001369

Abstract

Introduction

Individuals undergoing lung resection are at risk of developing postoperative pulmonary complications. These serious events occur in about 20 to 25% of the patients and are a major contributor to postoperative morbidity after thoracic surgery.1 Lung parenchyma loss, pain, diaphragmatic dysfunction and anaesthetic agents may impair both respiratory muscle function/coordination and central respiratory regulation, a combination of factors that predispose to the development of atelectasis.2,3 Atelectasis may go on to increase the risk of postoperative pneumonia and acute respiratory failure.4

The Boussignac system (Vygon, Écouen, France) generates continuous airway pressure (CPAP). High-velocity streams create a virtual valve allowing a pressure support level depending on the gas flow rate supplied.5 It is a compact, easy-to-use, disposable system, that makes it attractive for widespread use. We have previously shown that, compared with usual treatment, 6 h of prophylactic CPAP with the Boussignac system in the immediate postoperative period after lung resection improves gas exchange.6

We hypothesised that immediate, postoperative CPAP with the Boussignac system would reduce the incidence of atelectasis and pneumonia without increasing adverse events such as persistent air leaks and pneumothoraxes. The principal aim was to compare the incidence of the composite endpoint ‘atelectasis + pneumonia’ with and without CPAP.

Materials and methods

Ethics

The study was conducted in accordance with the Declaration of Helsinki. It was approved by the regional ethics committee: ‘Comité de Ética de la Investigación con Medicamentos (CEIm) Regional’, Calle Aduana, 29 - 3ª planta 28013 Madrid ([email protected]; approval number: EC 12/11 approval date: 14 March 2012). The trial was registered as EuDraCT 2010-022863-36 and NCT02771327. All included patients provided informed consent before the surgery.

Design

We performed an open-label randomised, controlled clinical trial. A 1 : 1 randomisation, stratified by centre was employed. The randomisation was generated by blocks of four elements that were unsystematically chosen using a list of random numbers generated by an EXCEL 2010 spreadsheet (Microsoft Corporation, Redmond, Washington, USA) at the research support unit of one of the participating hospitals. The assignation codes were stored in closed envelopes, which were opened on admission into the PACUs if the patients were already extubated or after extubation if they were not (this happened in one patient assigned to the control group).

Patients

Participants were recruited from the thoracic surgery departments of four university hospitals in Madrid (Spain) between March 2014 and December 2016. Inclusion criteria were an age older than 18 years and being scheduled for pulmonary resection either by thoracotomy or thoracoscopy. Exclusion criteria were obstructive sleep apnoea syndrome, facial deformation, significant bullous emphysema or immunosuppression. Further exclusion criteria were failure to extubate the patient within 4 h following the surgery and suspected bronchopleural fistula on admission to the postoperative anaesthesia care unit (PACU).

Intervention

After admission to the PACU, patients received either CPAP or usual care according to the assigned group. CPAP was administered continuously for 6 h through a Boussignac system (Vygon, Ecouen, France) that was adjusted to maintain a positive pressure close to 7 cmH2O, typically at 25 l min-1. The pressure was monitored with the manufacturer's supplied gauge at the start of the treatment, every 2 h thereon, at the end of the treatment and whenever the mask had to be readjusted. The flow to the Boussignac system was delivered by two independent oxygen and air sources to provide the inhaled fraction of oxygen (FIO2) needed to maintain arterial blood oxygen saturation (SaO2) over 92%. Patients were typically discharged from the PACU the morning after surgery. Usual peri-operative management was provided to all patients in both arms according to the standard practice at each hospital. This care included at least pre-operative evaluation of fitness,7 prophylactic administration of cefazolin I.V. protective ventilation as well as recruiting manoeuvres in the dependent lung during the procedure,8 postoperative regional analgesia, continuous oxygen supply at the PACU except for the time spent with CPAP in the treatment group, prophylactic postural and hygienic measures to prevent pneumonia at the PACU9 and physiotherapy and early rehabilitation (the next day) at the ward.

Outcomes

The primary outcome was the incidence of the composite endpoint ‘atelectasis + pneumonia’ during the hospital stay. At least four plain chest radiographs were performed: On admission and at discharge from the PACUs, 24 h after the intervention and before discharge from the hospital. A pulmonologist or radiologist at each centre, qualified in chest radiograph interpretation and blinded to the treatment group assessed the chest radiographs. Criteria for atelectasis were collapse or incomplete expansion of pulmonary parenchyma, identified by reversible increased density of the atelectatic portion of lung as well as displacement of the fissures towards the area of atelectasis, crowded air bronchograms, upward displacement of hemidiaphragm ipsilateral to the side of atelectasis, compensatory overinflation of unaffected lung or displacement of thoracic structures. In case of doubt between atelectasis or lung effusion, a thoracic ultrasound examination was performed.

Clinical diagnosis of pneumonia consisted of the combination of a newly established radiological infiltrate along with purulent secretions and one of the following criteria: fever, hypoxaemia or leukocytosis.9 Microbiological diagnosis was not included in the operative definition of pneumonia.

The first secondary outcome was the composite endpoint ‘persistent air leak + pneumothorax’. Persistent air leak was defined as a leak lasting more than 5 days.

The second secondary outcome was ‘severe adverse pulmonary events’ (without atelectasis or pneumonia). This secondary outcome was defined as acute episodes of hypoxaemic respiratory failure requiring a FiO2 more than 0.35 to achieve arterial blood saturation more than 92%, resting dyspnoea [modified Medical Research Council Dyspnoea Score (mMRC) = 4], severe bronchospasm or arterial CO2 partial pressure higher than 50 mmHg with arterial pH less than 7.35 that required a therapeutic intervention.

Total adverse respiratory events included the second secondary outcome (severe adverse pulmonary events) and the primary outcome (atelectasis + pneumonia).

Thirty-day postoperative mortality was a further outcome and was defined as death from any cause inside or outside the hospital within 30 days after surgery at which point all patients received a phone call.

Hospital stay duration was also an outcome and was calculated from the day of the intervention to the day of discharge.

Other variables

Patients’ characteristics, indication for surgery and pulmonary function variables were recorded. Because most of the patients suffered from a neoplasm, the Charlson comorbidity index 10 was calculated without accounting for malignancy scores. Heart rate, arterial blood pressure and SaO2 were continuously measured in the PACU from a cannulated artery. The effect of CPAP on gas exchange was measured by the analysis [IQR] PaO2/FiO2 ratio. Samples of arterial blood for gas were drawn on arrival at the PACU, after 7 and 24 h after at least 30 min on supplementary oxygen with a Venturi mask. The FIO2 supplied by the mask at the time of the sampling was recorded. Treatment-specific adverse events related to CPAP were also reported.

Sample size

On the basis of our previous experience, we expected that 20% of the patients had the primary outcome (atelectasis + pneumonia) in the standard care group.6 We expected that 18% of the patient in the CPAP group had the primary outcome. A sample size of 199 participants per group was needed to detect this 10% difference of the primary outcome with a power of 80%.6

Statistical analysis

Continuous variables were described by means and standard deviations (±SD) unless an assumption of normality could not be established. In such cases, the variables were summarised as medians and interquartile ranges [IQR]. Categorical variables were described as percentages. An intention-to-treat analysis was performed. χ2 tests for categorical variables were performed. Unpaired t-tests for continuous variables were performed. Mann–Whitney U tests were performed in data without normal distribution.

For the primary outcome, an adjusted relative risk (ARR) was estimated accounting for age, sex, ASA category, Charlson comorbidity index, type of resection, conventional thoracotomy or video-assisted thoracoscopic procedure and lung function. Similar adjustments were performed for secondary and further outcomes.

An exploratory ‘post hoc’ stratified analysis of the outcome ‘adverse respiratory outcome’ was performed according to the ‘Multifactorial Risk Index for Predicting Postoperative Respiratory Failure’ 11 by dividing the sample into two groups: ‘low- intermediate risk’ patients (class I–III, ≤27 points) and ‘high-risk’ patients (class IV and V, >27 points).11

Results

Four hundred and ninety-seven patients were eligible to participate, and 422 were finally included in the analysis (Fig. 1). Baseline demographics and intra-operative data were similar between the CPAP and the control group (Tables 1 and 2).

F1
Fig. 1:
CONSORT flow diagram.
Table 1 - Baseline description of the sample
Parameters Overall population (n = 422) CPAP group (n = 208) Control group (n = 214) P
Age (years) mean, [range] 63.9 [22 to 87] 64.3 [26 to 84] 63.5 [22 to 87] 0.424
Male sex, n % 262 62.2% 132 63.4% 130 61% 0.871
Current smokers, n % 22 5.2% 9 4.3% 13 5.6% 0.265
BMI (kg m-2), mean ± SD 26.9 ± 4.9 27.3 ± 5.2 26.4 ± 4.6 0.063
ASA III+IV, n % 210 49.4% 117 56.3% 93 43% 0.131
Mod. Charlson score 0–1, n % 336 79% 139 66.9% 149 70% 0.631
Mod. Charlson score >2, n % 133 31.5% 69 33.1% 64 30.0% 0.579
CAD, n % 30 7.1% 18 8.4% 12 5.7% 0.251
Heart failure, n% 16 3.8% 8 3.8% 8 3.7% 0.992
Atrial fibrillation, n % 21 4.9% 8 3.8% 13 6.1% 0.268
COPD or asthma, n% 98 23.3% 54 25.9% 44 20.6% 0.231
Ischemic peripheral vascular disease, n % 39 9.2% 20 9.6% 19 8.9% 0.855
Chronic renal failure, n % 21 4.9% 7 3.3% 14 6.7% 0.120
Chronic severe hepatic disease, n % 32 7.6% 14 6.7% 18 8.4% 0.731
Diabetes mellitus, n % 72 17.1% 41 19.7% 31 14.5% 0.595
Hb (mg dl−1) 13.4 ± 2.0 13.5 ± 1.9 13.3 ± 2.26 0.285
Baseline SaO2 (%) 94.6 ± 4.8 94.7 ± 5.4 94.2 ± 4.2 0.189
FEV1/FVC %, mean ± SD 73.3 ± 11.6 73.2 ± 11.2 73.4 ± 12.1 0.903
FEV1%, mean ± SD 91.3 ± 22.1 91.5 ± 22.7 91.1 ± 21.6 0.885
DLCO %, mean ±SD 85.4 ± 20.9 84.2 ± 22.8 85.7 ± 20.5 0.532
Primary lung cancer, n % 294 69.8% 149 71.6% 145 68.0% 0.291
Secondary lung cancer, n % 97 23.0% 47 22.5% 50 23.5% 0.395
Benign/low malignity, n % 29 7.0% 10 4.8% 19 9.0% 0.099
CAD, coronary artery disease; CPAP, continuous positive airway pressure; DLco, Single breath carbon monoxide diffusion test; FEV1, forced expiratory volume in the first second; FVC, forced vital capacity; Mod. Charlson score, Modified Charlson score without malignant tumours or metastases; P, statistical signification with the appropriate test.

Table 2 - Intra-operative data
Parameters Overall population (n = 422) CPAP Group (n = 208) Control group (n = 214)
Resection type
 Lobectomy, n % 261 62% 135 64.9% 126 58.8% 0.146
 Pneumonectomy, n % 8 1.9% 2 0.96% 6 2.88% 0.130
 Bilobectomy, n % 7 1.7% 2 1.0% 5 2.3% 0.215
 Segmentectomy n % 126 30% 57 27.4% 69 32.4% 0.214
 Metastasectomy, n % 20 (4.8%) 12 5.7% 8 3.3% 0.144
 VTC procedures 51 12.1% 27 13.0% 24 11.5% 0.360
Intra-operative tidal volume (ml kg−1)
 Before OLV, mean ± SD 6.9 ± 1.2 6.8 ± 1.2 7.0 ± 1.2 0.566
 60 min after OLV, mean ± SD 6.1 ± 1.1 6.1 ± 1.2 6.2 ± 1.1 0.535
Intra-operative maximal plateau pressure (mmHg)
 Before unilateral lung ventilation, mean ± SD 17.3 ± 4.5 17.8 ± 4.9 17.1 ± 4.7 0.558
 60 min after unilateral lung ventilation, mean ±SD 20.5 ± 4.5 20.6 ± 4.9 20.1 ± 5.0 0.540
Duration intervention (min)
 Duration of anaesthesia, mean ±SD 199 ± 80 201 ± 82 198 ± 79 0.515
 Duration of surgerya, mean ±SD 153 ± 74 153 ± 73 154 ± 75 0.505
CPAP, continuous positive airway pressure; OLV, one-lung ventilation; SD, standard deviation; VTC, video-assisted thoracoscopy.
aAs registered by the nurses in the electronic records from arrival to departure from the surgical room.

The mean duration of CPAP was 5.6 ± 1.7 h (Table 3). In the CPAP group, two patients dropped out in the first 15 min, another four dropped out in the first half an hour and another six more abandoned before the third hour (all of them included in the main analysis except for four in which consent was withdrawn); in total ,12 out of 212 did not complete the required period of CPAP (6%). As the four patients who withdrew their consent did not specify the cause for their decision, they are not included in the outcomes estimation (Table 4).

Table 3 - Postoperative data
Parameters Overall population (n = 422) CPAP group (n = 208) Control group (n = 214)a P
CPAP use (h), mean [range] 5.6 [0.3 to 6.5]
CPAP pressure (mmHg), mean [range] 8 [5 to 10]
Gas exchange
 At PACU admission
  FiO2% 0.35 ± 0.05 0.35 ± 0.07 0.35 ± 0.07 0.695
  Hb (mg dl−1) 12.9 ± 1.1 13.0 ± 1.6 12.8 ± 1.6 0.363
   PaO 2/FiO2 (kPa) 40.5 ± 12.4 39.5 ± 11.8 41.4 ± 13.1 0.112
  pH 7.32 ± 0.03 7.32 ± 0.04 7.32 ± 0.04 0.573
PaCO 2 (kPa) 6.1 ± 0.6 6.1 ± 0.8 6.1 ± 0.8 0.956
  SBP (mmHg) 133 ± 20 135 ± 22 132 ± 23 0.113
 At 7 h
  FiO2% 0.34 ± 0.06 0.33 ± 0.06 0.35 ± 0.09 0.011
  Hb (mg dl−1) 12.6 ± 1.2 12.7 ± 1.6 12.5 ± 1.6 0.156
   PaO 2 /FiO2 (kPa) 45.7 ± 14.9 47.8 ± 16.0 43.6 ± 13.4 0.001
  pH 7.37 ± 0.03 7.37 ± 0.04 7.37 ± 0.04 0.385
PaCO 2 (kPa) 5.4 ± 0.6 5.4 ± 0.7 5.4 ± 0.7 0.820
 At 24 h
  FiO2% 0.31 ± 0.04 0.31 ± 0.06 0.32 ± 0.06 0.174
  Hb (mg dl−1) 12.1 ± 1.1 12.2 ± 1.5 12.0 ± 1.6 0.214
   PaO2 /FiO2 (kPa) 47.6 ± 14.5 48.6 ± 14.6 46.6 ± 14.5 0.152
  pH 7.38 ± 0.03 7.38 ± 0.04 7.38 ± 0.04 0.935
   PaCO 2 (kPa) 5.6 ± 0.6 5.6 ± 0.8 5.6 ± 0.8 0.583
 Analgesia
  Epidural catheter, n % 43 (10.4%) 25 (12.0%) 18 (8.4%) 0.208
  intravenous 50 (11.8%) 19 (9.1%) 31 (14.5%) 0.075
  Paravertebral catheter 203 (48.2%) 101 (48.5%) 102 (47.8%) 0.397
  Combined 125 (29.6%) 65 (31.2) 60 (28.1%) 0.345
aIn one patient, the artery could not be cannulated. Combined analgesia = paravertebral or epidural plus intravenous analgesia.CPAP, continuous positive airway pressure; PaCO2, arteria blood carbon dioxide partial pressure; PaO2/FiO2, arterial blood oxygen partial pressure to inspiratory fraction of oxygen ratio; SD, standard deviation.

Table 4 - Outcomes and adverse events
Overall population (n = 422) CPAP group (n = 208) Control group (n = 214) P RR 95% CI ARR 95% CI
Atelectasis and pneumonia, n % 93 22.0% 35 16.9% 58 27.1% 0.008 0.62 (0.42 to 0.90) 0.53 (0.30 to 0.93)
Severe adverse pulmonary events, n % 16 3.8% 4 1.9% 12 5.6% 0.046 0.34 (0.11 to 1.05) 0.32 (0.09 to 1.00)
Total adverse respiratory events, n % 109 25.8% 39 18.7% 71 33.2% 0.001 0.57 (0.40 to 0.79) 0.48 (0.33 to 0.73)
Prolonged leak and pneumothorax, n % 62 14.5% 33 15.5% 29 13.6% 0.569 1.17 (0.74 to 1.86) 0.92 (0.51 to 1.65)
Readmission to PACU, n % 21 5.0% 10 4.8% 11 5.2% 0.393 0.94 (0.41 to 2.16) 0.96 (0.39 to 2.37)
Length of hospital stay (day), median [IQR] 4 [3 to 6.75] 4 [3 to 6] 5 [3 to 7] 0.667 a
Length of hospital stay (day), min, max 1 107 1 96 1 107
Mortality, n % 6 1.4% 3 1.4% 3 1.4% 0.977 1.03 (0.21 to 5.04) 0.98 (0.19 to 4.98)
Treatment specific adverse events
 Dryness 93 21.7% 46 22.1% 47 22.1% 0.399 1.01 (0.70to 1.44)
 Claustrophobia 59 13.8% 54 26.0% 5 2.3% 0.001 11.11 (4.54 to 27.52)
 Skin erosions/maceration/acne 41 9.7% 33 15.9% 8 1.9% 0.001 4.24 (2.01 to 8.97)
 Conjunctivitis 30 7.0% 26 12.5% 4 1.9% 0.038 6.69 (2.37 to 18.83)
 Aerophagia 14 3.3% 5 2.4% 9 4.2% 0.343 0.57 (0.19 to 1.68)
 intolerance 9 2.1% 8 3.8% 1 0.5% 0.001 8.23 (1.04 to 65.23)
 Noise 8 1.9% 7 3.4% 1 0.5% 0.036 7.20 (0.89 to 58.03)
 Nasal congestion/epistaxis 7 1.6% 4 1.0% 3 0.7% 0.391 1.37 (0.31 to 6.05)
Headache 5 1.2% 3 1.4% 2 0.9% 0.388 1.54 (0.26 to 9.14)
 Chest muscle pain 5 1.2% 4 1.9% 1 0.5% 0.311 4.12 (0.46 to 36.52)
ARR, adjusted relative risk; CI, confidence interval; IQR, interquartile range; RR, relative risk.
aMann--Whitney U test. Severe adverse respiratory events: See Materials and methods for an operative definition. Total adverse respiratory events: sum of atelectasis, pneumonia and other acute severe respiratory events.

The primary outcome was observed in 35 (17%) patients with CPAP and 58 (27%) without CPAP (ARR 0.53; 95% CI 0.30 to 0.93) (Table 4).

The first secondary outcome ‘persistent air leak + pneumothorax’ was observed in 33 (16%) patients with CPAP and 29 (14%) without CPAP (ARR 0.92; 95% CI 0.51 to 1.65) (Table 4).

The second secondary outcome ‘severe adverse pulmonary events’ was observed in four (2%) patients with CPAP and 12 (6%) without CPAP (ARR 0.32; 95% CI 0.09 to 1.00) (Table 4).

Total adverse respiratory events were lower in the high-risk patients with CPAP [seven out of 36 (19%) vs. 24 out of 41 (59%); 0.30; 95% CI 0.13 to 0.68] (Table 5).

Table 5 - Outcomes by postoperative respiratory failure index
Parameters Overall population CPAP group Control group P RR 95%CI
Low to moderate risk n = 345 n = 172 n = 173
 Total adverse respiratory events, n % 79 22.8% 32 18.6% 47 27.2% 0.114 0.70 (0.47 to 1.05)
 Length of hospital stay (day), median [IQR] 4 [6] 4 [6] 4 [6] 0.301a
High risk n = 77 n = 36 n = 41
 Total adverse respiratory events, n % 31 37.7% 7 19.4% 24 58.5% 0.003 0.30 (0.13 to 0.68)
 Length of hospital stay (day), median [IQR] 5 [4] 5 [3] 7 [4] 0.007a
IQR, interquartile range.
aMann--Whitney U Adverse respiratory events is the sum of Temporary adverse respiratory events+ atelectasis + pneumonia. ‘Total adverse respiratory events’ are the sum of atelectasis, pneumonia and other acute severe respiratory events (i.e. episodes of sever acute respiratory symptoms or failure requiring some intervention). See Materials and methods for an operative definition.

Discussion

We found that prophylactic CPAP with a positive pressure between 5 and 10 cmH2O was associated with a significantly lower incidence of the primary outcome (atelectasis and pneumonia) without increasing the occurrence of secondary outcome (persistent air leaks and pneumothorax). An exploratory subanalysis, stratifying patients according to their respiratory failure risk index,11 suggests that high-risk patients may benefit the most from the effect of immediate postoperative CPAP.

A recent multicentre randomised clinical trial conducted by Lorut et al.,12 which included 390 participants with COPD compared the use of prophylactic noninvasive ventilation intermittently delivered to patients for 1 h, six times per day, for 2 days following surgery. Neither the rate of severe adverse respiratory events [defined by at least two of the following criteria: respiratory rate (30 min−1, PaO2/FiO2 less than 200 mmHg, PaCO2 increase of more than 10 mmHg above baseline postoperative value or new pulmonary infiltrates on the chest radiograph] (31.5 vs. 30.7%), nor hospital stay (19 ± 40 vs. 16 ± 30 days) were different between treatment and control group.12

Our study, however, has some important differences that could explain the discrepancies. First, all of the patients included in the study by Lorut et al.12 had COPD. Second, we administered CPAP continuously rather than intermittently and many fewer pneumonectomies were performed (2% in our study vs. 12% in Lorut's one).

In another randomised clinical trial of 163 stage I lung cancer patients with normal lung function, the incidence of cardiorespiratory complications was lower in the group receiving intermittent CPAP (8 to 12 cmH2O, 2 h three times a day, for 3 days).13 However, no differences in atelectasis were noted.

On the basis of these two trials and on our results, it may be hypothesised that continuous CPAP could be more effective than intermittent noninvasive ventilation or CPAP for the prevention of major adverse pulmonary events.

Our study had several limitations. First, we did not use a sham CPAP in the control group. It is difficult to establish a sham treatment in clinical practice. The absence of a sham treatment could have introduced an information bias. However, the study was blinded for the interpreters of chest radiographs.

Second, the quality of chest radiographic interpretation during the immediate postoperative period may be impaired because chest X-ray is performed in a bedridden patient. However, interpretations were consistent independent of the time point.

Third, different investigators interpreted chest X-rays; however, consistency between the interpreters was tested before the study and interrater reliability was good.

Fourth, pneumonia diagnosis was established based on clinical and radiological criteria only.9 However, these criteria did not completely correspond to the CDC criteria of pneumonia. Pneumonia could be overdiagnosed, which may explain the absence of difference in the outcome ‘length of hospital stay’. This absence of difference could be also related to low frequency of pneumonia in both groups and, therefore, a low impact on length of hospital stay.

Fifth, the study included two surgical interventional concepts – thoracotomy and thoracoscopy. Postoperative pulmonary function is more rapidly improved after thoracoscopy. A mismatch of these interventional concepts between the two groups could impact on the outcomes. However, the groups were well matched and adjusted analyses did not change the result of the outcomes.

In conclusion, our study observed that the prophylactic use of Boussignac CPAP immediately after thoracic surgery is an effective prophylactic treatment to decrease the incidence of the composite endpoint ‘atelectasis + pneumonia’ without increasing the incidence of the composite endpoint ‘persistent air leak + pneumothorax’.

Acknowledgements relating to this article

Assistance with the study: we would like to acknowledge to all the collaborators listed in the supplementary appendix 1 and to Maria de la Cruz, of the Research Unit of the ‘Institute de Investigación Sanitaria Gregorio Marañón’ for her assistance with all the processes that led to the approval of the trial. We also want to acknowledge all those who participated in the care of the patients, data collection and quality verification and the blinded interpreters of chest radiographies, listed in supplement 1, https://links.lww.com/EJA/A390.

Financial support and sponsorship: this work was supported by the FIS (Fondo de Investigaciones Sanitarias), Health Research Fund, ‘Instituto de Salud Carlos III’ grant n° PI12/02734, co-financed by the European Union through the European Regional Development Fund (ERDF), Fondo Europeo de Desarrollo Regional (FEDER), and by NEUMOMADRID (Madrid Pneumological society).

Conflicts of interest: none.

Presentations: [PA3065] At European Respiratory Society International Congress 2016 London, September de 2016. European Respiratory Journal 2016;48 Suppl 60 and at the Barcelona- Boston Lung conference 2016. Barcelona.

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