Aim: The effect of systemic corticosteroids in the management of patients with post intubation tracheal stenosis.
Inclusion criteria: All patients with post intubation tracheal stenosis who are not ideal candidate for airway surgery at the time of first presentation.
Exclusion criteria: patients presented with tracheostomy or t-tube; patients presented 6 months after the intubation time; patients younger than 15 years old.
Population: The patients with post intubation tracheal stenosis
Sample size: 120 patients
Intervention: drug/placebo, both the participants and the investigators are blinded regarding the intervention
Time of intervention: Intervention is performed after the first bronchoscopy for 6 months.
Outcome: the number of patients who should finally undergo airway resection, the length of resected tracheal segment, the number of bronchoscopic procedures, the time intervals between bronchoscopic procedures before an airway resection
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014103019760N1
Registration date:2014-12-22, 1393/10/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-22, 1393/10/01
Registrant information
Name
Mohammad Behgam Shadmehr
Name of organization / entity
Tracheal Diseases Research Center, NRITLD, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2712 2016
Email address
mbshadmehr@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
National Research Institute of Tuberculosis and Lung Diseases
Expected recruitment start date
2009-01-20, 1387/11/01
Expected recruitment end date
2012-11-21, 1391/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
" The effect of systemic corticosteroids in the management of patients with post intubation tracheal stenosis"
Public title
Do systemic corticosteroids have any role in the management of Post-Intubation Tracheal Stenosis? A randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients with post intubation tracheal stenosis who are not ideal candidate for airway surgery at the time of first presentation.
Exclusion criteria: patients presented with tracheostomy or t-tube; patients presented 6 months after the intubation time; patients younger than 15 years old.
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti university of medical sciences,National Research institute of Tu
Street address
Masih Daneshvari hospital, Daar Abad, Niavaran, Tehran, Iran
City
Tehran
Postal code
Approval date
2008-12-18, 1387/09/28
Ethics committee reference number
C-87-778
Health conditions studied
1
Description of health condition studied
Tracheal Stenosis
ICD-10 code
J39.8
ICD-10 code description
Other specified diseases of upper respiratory tract
Primary outcomes
1
Description
the number of patients who undergo airway resection;
Timepoint
6 months following end of intervention
Method of measurement
the number of patients who undergo airway surgery
2
Description
the length of resected tracheal segment
Timepoint
whenever the resetion and anastomosis of the trachea is performed.
Method of measurement
rigid bronchoscopy, pathology report
Secondary outcomes
1
Description
the number of bronchoscopies
Timepoint
before an airway resection
Method of measurement
counting the number of bronchoscopies before surgery
2
Description
the time intervals between bronchoscopic procedures
Timepoint
before an airway resection
Method of measurement
days interval between bronchoscopic procedures
Intervention groups
1
Description
Intervention group: drug: capsule containing 15 mg of prednisolon ; dose: one capsule/day; time of consumption: 6 months
Category
Treatment - Drugs
2
Description
Control group: placebo: capsule with no medicine; dose: one capsule/day; time of consumption: 6 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
National research Institute of Tuberculosis and Lung diseases, Masih Daneshvai Hospital
Full name of responsible person
Dr. Roya Farzanegan
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for National research institute of tuberculosis and lung diseases,Dr Massih Daneshva
Full name of responsible person
Dr. Hamidreza Jamaati, associate Professor of critical care
Street address
Dr Massih Daneshvari hospital,Daar Abad, Niavaran, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for National research institute of tuberculosis and lung diseases,Dr Massih Daneshva
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tracheal Diseases Research Center, NRITLD, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Behgam Shadmehr
Position
Professor of surgery
Other areas of specialty/work
Street address
NRITLD, Masih Daneshvari Hospital, Daar Abad Niavaran, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2610 5387
Fax
Email
mbshadmehr@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tracheal diseases research center, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Behgam Shadmehr
Position
Professor of Surgery
Other areas of specialty/work
Street address
NRITLD, Masih Daneshvari Hospital, Daar Abad, Niavarn, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2610 5387
Fax
Email
mbshadmehr@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tracheal Diseases Research Center, NRITLD, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roya Farzanegan
Position
MD,PhD by research student
Other areas of specialty/work
Street address
Masih Daneshvari hospital, Daar Abad Niavaran, Tehran
City
Tehran
Postal code
19569-44413
Phone
+98 21 2610 5387
Fax
Email
royafarzanegan@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)