Clinical trial · Interventional
Concomitant Tracheostomy and Lung Resection
Concomitant Tracheostomy and Lung Resection in Patient With Low Postoperative Pulmonary Function
NCT01053624CI-TRIAL-00004299unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This protocol has been designed to determine if tracheostomy performed immediately after lung operation (i.e. concomitant tracheotomy) could improve the postoperative outcome of high risk patients. We hypothesized that concomitant tracheotomy could reduce the length of mechanical ventilation and the number of respiratory complications.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tracheostomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- number of mechanical ventilation days after operation until discharge
- timeFrame
- 2 months
Secondary outcomes (7)
- measure
- 60 days mortality rate
- timeFrame
- 2 months
- measure
- ICU length of stay
- timeFrame
- 2 months
- measure
- hospital length of stay
- timeFrame
- 2 months
- measure
- cumulative incidence of postoperative respiratory complications defined as pneumonia, re-ventilation, atelectasis needing fiberbronchoscopy, non cardiogenic pulmonary edema, air leakage >7 days, broncho-pleural fistula, pulmonary embolism, empyema
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * age between 18 and 79 years old * preoperative diagnosis of suspected lung cancer * patient considered operable according to the guidelines * 30% \< postoperative predicted FEV1 \< 50% * informed consent obtained by patient Exclusion Criteria: * \- age less than 18 and more than 79 * pregnant woman * preoperative tracheostomy * postoperative vocal cord paralysis * postoperative diaphragmatic paralysis (except for pneumonectomy) * neuromuscular disorders * previous pharyngeal or laryngeal surgery * anatomical deformity of the neck making risky a tracheostomy * consent refusal
References
Publications (1)
- DERIVEDFilaire M, Tardy MM, Richard R, Naamee A, Chadeyras JB, Da Costa V, Bailly P, Eisenmann N, Pereira B, Merle P, Galvaing G. Prophylactic tracheotomy and lung cancer resection in patient with low predictive pulmonary function: a randomized clinical trials. Chin Clin Oncol. 2015 Dec;4(4):40. doi: 10.3978/j.issn.2304-3865.2015.11.05. PMID 26730752