Comparative study of the relative frequency of short-term complications ofpercoutaneous dilataion tracheostomy Vs open tracheostomy in Alzahra hospital
The aim of this study is to determine Comparative study of the relative frequency of short-term complications of percutaneous dilatation tracheostomy Vs open tracheostomy in Alzahra hospital. patients who needed the non-emergency tracheostomy are included and with Emergency patients, dissatisfaction with the tracheostomy and coagulopathy are excluded. 40 patients who intubated in ICU division and need long term ventilation support, are selected and divided in two groups randomly, group1: Percutaneous dilatation tracheostomy. Group2: surgical tracheostomy . primary outcome is to assay short-term complications.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122529726N2
Registration date:2017-02-13, 1395/11/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-13, 1395/11/25
Registrant information
Name
Mohsen Kolahdouzan
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3669 2277
Email address
kolahdouzan@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the relative frequency of short-term complications ofpercoutaneous dilataion tracheostomy Vs open tracheostomy in Alzahra hospital
Public title
Evaluation of short-term complications tracheostomy
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion: patients who needed the non-emergency tracheostomy
Exclusion: Emergency patients; dissatisfaction with the tracheostomy; coagulopathy
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan
City
Isfahan
Postal code
Approval date
2008-09-22, 1387/07/01
Ethics committee reference number
388037
Health conditions studied
1
Description of health condition studied
Tracheostomy Complication
ICD-10 code
J95.0
ICD-10 code description
Tracheostomy malfunction
Primary outcomes
1
Description
short term complication
Timepoint
before surgery and two weeks after surgery
Method of measurement
checklist
Secondary outcomes
1
Description
surgery duration time
Timepoint
intraoperative
Method of measurement
Minute
Intervention groups
1
Description
percutaneous dilatation tracheostomy as a case group
Category
Treatment - Surgery
2
Description
control: surgical tracheostomy
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences
Full name of responsible person
Mohsen Kolahdouzan
Street address
Surgery Department, Alzahra Hospital, Soffeh Avenue, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr.Mehdi Nematbakhsh
Street address
Isfahan University of medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
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
Isfahan University of Medical Sciences
Full name of responsible person
Dr.Mohsen Kolahdouzan
Position
assistant professor
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3620 1293
Fax
Email
kolahdouzan@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan university of medical sciences
Full name of responsible person
Gholamreza Mohajeri
Position
Associate professor
Other areas of specialty/work
Street address
Surgery Department, Alzahra Hospital, Soffeh Avenue, Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 31 3620 1293
Fax
+98 31 3620 1250
Email
gh_mohajeri@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mohsen Kolahdouzan
Position
assistant professor
Other areas of specialty/work
Street address
Surgery Department, Alzahra Hospital, Soffeh Avenue, Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 31 3620 2020
Fax
Email
kolahdouzan@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)