Background: This randomized clinical trial is designed to determine the optimum timing for tracheostomy in intensive care unit patients (intubated and ventilator dependent) and to compare benefits, complications and mortality between early and late tracheostomy.
Materials & Methods:
Inclusion criteria: Intensive care unit cases, Intubated and ventilator dependent and patient anticipated to be ventilator dependent for more than 7 days (According to clinical conditions and by physician’s opinion).
Exclusion criteria: Emergency tracheostomy, Tracheostomy performed between 10th and 13rd days and Tracheostomy after 28th day.
Eligible 162 patients admitted in Shariati Hospital between 2014 and 2015 were randomly categorized in two groups (early and late tracheostomy).
Sequential Organ Failure Assessment (SOFA) score was used to compare the severity of illness before tracheostomy.
Open tracheostomy was performed only by a single surgeon.
Complications, mortality, as well as ICU and total hospital stay were compared between two groups.
Key words: early Tracheostomy, late tracheostomy, infection, hospital stay
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011025934N1
Registration date:2016-04-28, 1395/02/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-28, 1395/02/09
Registrant information
Name
Amir Fazlali
Name of organization / entity
Shariati hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2230 4085
Email address
dr.fazlali@gmail.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2016-05-04, 1395/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Early tracheostomy versus Late tracheostomy, comparison of morbidity and mortality in Shariati Hospital's ICU between 2014 and 2015
Public title
Define the best time for tracheotomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Admission in Surgical and Medical ICU; Intubated an dependent to ventilator; Need more than 7 days of intubation based on physician judgment
Exclusion criteria: Emergent tracheostomy; Combination of tracheotomy and another operation; Tracheostomy between days of 10 to 13; Tracheostomy after the day 28
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
162
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
The ethics committee of Tehran University of Medical Sciences
Street address
Medical School Building, Poursina st., 16 Azar st., Enqelab sq., Tehran
City
Tehran
Postal code
Approval date
2016-01-30, 1394/11/10
Ethics committee reference number
IR.TUMS.REC.1394.1779
Health conditions studied
1
Description of health condition studied
Tracheostomy time managment
ICD-10 code
Z93.0
ICD-10 code description
Tracheostomy status
Primary outcomes
1
Description
Arythmia
Timepoint
Post Op to Extubation
Method of measurement
Cardiac Monitoring and then EKG
2
Description
Infectious complication
Timepoint
Post Op to Extubation
Method of measurement
Bacterimia, Fungemia, Sepsis and Septic shok
3
Description
Respiratory complication
Timepoint
Post Op to Extubation
Method of measurement
Atelectasia, Pneumonia and ARDS (CXR and CT Scan)
4
Description
MOD
Timepoint
Post Op to Extubation
Method of measurement
Renal, Hepatic, Coagulation and ....
5
Description
Mortality
Timepoint
Post Op to Extubation
Method of measurement
Viatla sign
6
Description
Intubation and ICU stay time
Timepoint
Post Op to Extubation
Method of measurement
Documentation
Secondary outcomes
empty
Intervention groups
1
Description
Control: Open tracheotomy (a small incision below the cricoid cartilage, thyroid isthmectomy and then tracheotomy) was performed in the operating room under general anesthesia for patients
Category
Treatment - Surgery
2
Description
Interventionl: Open tracheotomy (a small incision below the cricoid cartilage, thyroid isthmectomy and then tracheotomy) was performed in the operating room under general anesthesia for patients
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Dr. Amir Fazlali
Street address
General surgery ward - Shatiati hospital - Jalal-e al-e Ahmad cross - North Kargar st.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Kaviani
Street address
Poor sina st., 16th Azar st., Enqelab sq., Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Shariati hospital
Full name of responsible person
Amir Fazlali
Position
General surgery resident
Other areas of specialty/work
Street address
General surgeryward - Shatiati hospital - Jalal-e al-e ahmad cross - north Kargar st.
City
Tehran
Postal code
Phone
+98 21849012455
Fax
Email
dr.fazlali@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shatiati hospital
Full name of responsible person
Dr. Ali Ghorbani Abdegah
Position
Thorax surgen
Other areas of specialty/work
Street address
General surgeryward - Shatiati hospital - Jalal-e al-e ahmad cross - north Kargar st.
City
Tehran
Postal code
Phone
+98 21849012455
Fax
Email
aliabdehgah@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shariati hospital
Full name of responsible person
Amir Fazlali
Position
General surgery resident
Other areas of specialty/work
Street address
General surgeryward - Shatiati hospital - Jalal-e al-e ahmad cross - north Kargar st.
City
Tehran
Postal code
Phone
+98 21849012455
Fax
Email
dr.fazlali@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)