title: Prophylactic tracheotomy and lung cancer resection in patient with low predictive pulmonary function: a randomized clinical trials.
abstract: BACKGROUND
  Whether prophylactic tracheotomy can shorten the duration of mechanical ventilation (MV) in high risk patients eligible for lung cancer resection. The objective was to compare duration of MV and outcome in 39 patients randomly assigned to prophylactic tracheotomy or control.
  
  
  METHODS
  Prospective randomized controlled, single-center trial (ClinicalTrials.gov Identifier: NCT01053624). The primary outcome measure was the cumulative number of MV days after operation until discharge. The secondary outcome measures were the 60 days mortality rate, the ICU and the hospital length of stay, the incidence of postoperative respiratory, cardiac and general complications, the reventilation rate, the need of noninvasive ventilation (NIV), the need of a tracheotomy in control group and the tracheal complications.
  
  
  RESULTS
  The duration of MV was not significantly different between the tracheotomy group (3.5±6 days) and the control group (4.7±9.3 days) (P=0.54). Among patients needing prolonged MV >4 days, tracheotomy patients had a shortened duration of MV than control patients (respectively 11.4±7.1 and 20.4±9.6 days, P=0.04). The rate of respiratory complications were significantly lower in the tracheotomy group than in the control group (28% vs. 51%, P=0.03). Six patients (15%) needed a postoperative tracheotomy in the control group because of a prolonged MV >7 days. Tracheotomy was associated with a reduced need of NIV (P=0.04). There was no difference in 60-day mortality rate, cardiac complications, intensive care unit and hospital length of stay. No death was related with the tracheotomy.
  
  
  CONCLUSIONS
  Prophylactic tracheotomy in patients with ppo FEV1 <50% who underwent thoracotomy for lung cancer resection provided benefits in terms of duration of prolonged MV and respiratory complications but was not associated with a decreased mortality rate, ICU and hospital length of stay and non-respiratory complications.
authors.affiliation: Department of Thoracic Surgery, Jean Perrin Cancer Center, 58 Rue Montalembert, BP 392, 63011 Clermont-Ferrand, France. marc.filaire@cjp.fr.
authors.forename: Marc
authors.initials: M
authors.lastname: Filaire
authors.affiliation: Departement of Thoracic Surgery, Jean Perrin Cancer Center, 63011 Clermont-Ferrand, France.
authors.forename: Marie M
authors.initials: MM
authors.lastname: Tardy
authors.affiliation: INRA, Unité Mixte de Recherche 1019, Centre de Recherche en Nutrition Humaine Auvergne, Clermont-Ferrand, France; Department of Sport Medicine and Functional Explorations, Gabriel Montpied University Hospital, 63003 Clermont-Ferrand, France.
authors.forename: Ruddy
authors.initials: R
authors.lastname: Richard
authors.affiliation: Departement of Thoracic Surgery, Jean Perrin Cancer Center, 63011 Clermont-Ferrand, France.
authors.forename: Adel
authors.initials: A
authors.lastname: Naamee
authors.affiliation: Departement of Thoracic Surgery, Jean Perrin Cancer Center, 63011 Clermont-Ferrand, France.
authors.forename: Jean Baptiste
authors.initials: JB
authors.lastname: Chadeyras
authors.affiliation: Departement of Thoracic Surgery, Jean Perrin Cancer Center, 63011 Clermont-Ferrand, France.
authors.forename: Valence
authors.initials: V
authors.lastname: Da Costa
authors.affiliation: Departement of Thoracic Surgery, Jean Perrin Cancer Center, 63011 Clermont-Ferrand, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Bailly
authors.affiliation: Departement of Anesthesiology, Jean Perrin Cancer Center, 63011 Clermont-Ferrand, France.
authors.forename: Nathanaël
authors.initials: N
authors.lastname: Eisenmann
authors.affiliation: University Hospital Clermont-Ferrand, Biostatistics Unit (DRCI), Clermont-Ferrand, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Pereira
authors.affiliation: Department of Pneumology, Gabriel Montpied University Hospital, 63003 Clermont-Ferrand, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Merle
authors.affiliation: Departement of Thoracic Surgery, Jean Perrin Cancer Center, 63011 Clermont-Ferrand, France; Department of Anatomy, College of Medicine, Université d'Auvergne, 63000 Clermont-Ferrand, France.
authors.forename: Géraud
authors.initials: G
authors.lastname: Galvaing
mesh_terms: D000368:Aged; D005260:Female; D005541:Forced Expiratory Volume; D005602:France; D006801:Humans; D007902:Length of Stay; D008168:Lung / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D008175:Lung Neoplasms / Q000401:mortality / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011013:Pneumonectomy / Q000009:adverse effects / Q000401:mortality; D011446:Prospective Studies; D020127:Recovery of Function; D012121:Respiration, Artificial / Q000009:adverse effects; D012140:Respiratory Tract Diseases / Q000209:etiology / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D012307:Risk Factors; D013908:Thoracotomy / Q000009:adverse effects / Q000401:mortality; D013997:Time Factors; D014140:Tracheotomy / Q000009:adverse effects / Q000401:mortality; D016896:Treatment Outcome
keywords: Lung cancer; pulmonary function tests; thoracic surgery; tracheotomy