NCT01053624

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3 lung-cancer

Timeline
Completed

Started Oct 2001

Longer than P75 for phase_3 lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2010

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 21, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

January 19, 2011

Status Verified

January 1, 2011

Enrollment Period

8.7 years

First QC Date

January 5, 2010

Last Update Submit

January 18, 2011

Conditions

Lung Cancer

Keywords

Tracheostomy and thoracic surgerypostoperative complicationspulmonary surgical proceduresrespiratory failure

Outcome Measures

Primary Outcomes (1)

  • number of mechanical ventilation days after operation until discharge

    2 months

Secondary Outcomes (7)

  • 60 days mortality rate

    2 months

  • ICU length of stay

    2 months

  • hospital length of stay

    2 months

  • 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

    2 months

  • cumulative incidence of postoperative cardiac complications defined as arrythmia needed treatment, cardiac failure needing inotrop drug, acute coronary stroke

    2 months

  • +2 more secondary outcomes

Interventions

TracheostomyPROCEDURE

This protocol has been design 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

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age between 18 and 79 years old
  • preoperative diagnosis of suspected lung cancer
  • patient considered operable according to the guidelines
  • % \< postoperative predicted FEV1 \< 50%
  • informed consent obtained by patient

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (1)

  • Filaire 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: 26730752DERIVED

MeSH Terms

Conditions

Lung NeoplasmsPostoperative ComplicationsRespiratory Insufficiency

Interventions

Tracheostomy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration Disorders

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsOstomySurgical Procedures, OperativeOtorhinolaryngologic Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Marc Filaire, MD

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Lacarin

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 5, 2010

First Posted

January 21, 2010

Study Start

October 1, 2001

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

January 19, 2011

Record last verified: 2011-01

Locations

FR(1)