title: Regulated tailored suction vs regulated seal: a prospective randomized trial on air leak duration.
abstract: OBJECTIVE
  The objective of this study was to compare the air leak duration of two regulated chest tube modes following pulmonary lobectomy.
  
  
  METHODS
  This is a prospective randomized trial on 100 consecutive pulmonary lobectomies (2010-11) performed for lung cancer. A single 24-French chest tube was connected to an electronic system capable of maintaining the pleural pressure within preset values (regulated suction mode) or within a physiological range (regulated seal mode). Patients were randomized to two groups: Group 1, regulated individualized suction (range: -11 to -20 cmH2O, according to lobectomy type); Group 2, regulated seal (-2 cmH2O). The main endpoint was the duration of air leak (h) calculated from the end of the operation to a value consistently below 20 ml/min. Patients with prolonged air leak (>168 h) were connected to a portable device before discharge. Their air leak duration was considered as 192 h. The sample size was calculated to detect 1-day difference in air leak duration with a statistical power of 80%.
  
  
  RESULTS
  The two groups were well matched for several baseline and surgical characteristics. No crossovers occurred between groups. The average air leak duration (Group 1: 28 vs Group 2: 22.2, P = 0.6), and the number of patients with prolonged air leak (Group 1: 5 vs Group 2: 4, P = 0.7) and with other complications (Group 1: 6 patients vs Group 2: 7 patients, P = 0.9) were similar between the groups. Sixteen patients of Group 1 and 21 of Group 2 had an air leak present immediately after extubation. Among them, patients of Group 2 (regulated seal) had an air leak lasting 34.5 h less than those of Group 1 (regulated suction) (52.9 vs 87.4, P = 0.07).
  
  
  CONCLUSIONS
  Regulated seal is as effective and safe as regulated suction in managing chest tubes following lobectomy. This information demonstrates with objective data the non-superiority of regulated suction vs regulated seal and may assist in future investigations on regulated pleural pressure.
authors.affiliation: Division of Thoracic Surgery, Ospedali Riuniti Ancona, Ancona, Italy. brunellialex@gmail.com
authors.forename: Alessandro
authors.initials: A
authors.lastname: Brunelli
authors.forename: Michele
authors.initials: M
authors.lastname: Salati
authors.forename: Cecilia
authors.initials: C
authors.lastname: Pompili
authors.forename: Majed
authors.initials: M
authors.lastname: Refai
authors.forename: Armando
authors.initials: A
authors.lastname: Sabbatini
mesh_terms: D000368:Aged; D015505:Chest Tubes; D016009:Chi-Square Distribution; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011013:Pneumonectomy / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods*; D011030:Pneumothorax / Q000175:diagnosis; D011446:Prospective Studies; D018709:Statistics, Nonparametric; D013396:Suction / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods*