A double blind randomized controlled clinical trial study of comparison between two method of minisurgical percutaneous dilated tracheostomy, the standard method (Use of Tracheal Tube) or I gel insertion
The comparison between two method of PDT insertion technique, the standard method and I GEL implication .
Design
In this study, 66 patients were candidates for PDT and were eligible to enter the study. Participants are randomly divided into intervention and control groups and each participant is assigned a code.
Settings and conduct
This study, conducted as a double-blind clinical trial, was conducted at Masih Daneshvari Education and research Center, Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients under mechanical ventilation which They will have needs to maintain the tracheal tube more than 1 week; Lacking evidence of ischemic heart disease; Without any damage to the cervical spine; Without morbid obesity; The PT, PTT, INR and platelet in normal range. Exclusion criteria: No informe conscense; Failure in the relevant procedure.
Intervention groups
In the Conventional Method that will perform with ETT it will retract till to vocal cords to open enough space for the catheter insertion.
Main outcome variables
The control of tracheal puncture
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150107020592N8
Registration date:2018-01-13, 1396/10/23
Registration timing:registered_while_recruiting
Last update:2018-01-13, 1396/10/23
Update count:0
Registration date
2018-01-13, 1396/10/23
Registrant information
Name
Seyed Mohammad Reza Hashemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 9944
Email address
iran.criticalcare@yahoo.com
Recruitment status
Recruitment complete
Funding source
Masih Daneshvari Hospital the Edjucational , Research and Treatment center.
Expected recruitment start date
2017-10-12, 1396/07/20
Expected recruitment end date
2018-04-09, 1397/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A double blind randomized controlled clinical trial study of comparison between two method of minisurgical percutaneous dilated tracheostomy, the standard method (Use of Tracheal Tube) or I gel insertion
Public title
The Comparison between two method of minisurgical percutaneous dilated tracheostomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients under mechanical ventilation which They will have needs to maintain the tracheal tube more than 1 week.
Lacking evidence of ischemic heart disease.
Without any damage to the cervical spine.
Without morbid obesity.
The PT , PTT, INR and platelet in normal range.
Exclusion criteria:
No inform consent; Failure in the relevant procedure.
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
The groups randomization will performed based on the A and B allocation group. this process will managed by computerizing allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
With regard to blindness, the study of the patient and the person who carries out the PDT is blind to the study, and the third person who is nurse in the department who is unaware of the study, are filling the questionnaire.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Masih Daneshvari Hospital the Edjucational , Research and Treatment center.
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2017-10-04, 1396/07/12
Ethics committee reference number
IR.SBMU.NRITLD.REC.1396.378
Health conditions studied
1
Description of health condition studied
The relationship between two methods of small throat surgery through the skin
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The control of tracheal puncture
Timepoint
During the process
Method of measurement
Check list
2
Description
Duration of the procedure
Timepoint
During the process
Method of measurement
Based on minutes
3
Description
Peripheral blood oxygen saturation
Timepoint
During the process
Method of measurement
In terms of the oximeter pulse number
Secondary outcomes
1
Description
Abnormal bleeding from Trachea.
Timepoint
During the procedure
Method of measurement
Based on clinical status
2
Description
Pneumothorax
Timepoint
During the procedure
Method of measurement
Based on clinical status
3
Description
Subcutaneous emphysema
Timepoint
During the procedure
Method of measurement
Based on clinical status
4
Description
Arrhythmia
Timepoint
During the procedure
Method of measurement
Based on electrocardiogram monitor monitoring
Intervention groups
1
Description
In the Conventional Method that will perform with ETT it will retract till to vocal cords to open enough space for the catheter insertion.
Category
Treatment - Surgery
2
Description
In Igel Method after the airway assessment and patient suctioning (to avoid aspiration),the Igel will lubricated by gelly lubricant and it will iuserted orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital the Edjucational , Research and Treatment center
Full name of responsible person
Dr Seyyed Mohamadreza Hashemian
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2912 3100
Email
iran.criticalcare@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Masih Daneshvari Hospital
Full name of responsible person
Dr. Seyyed Mohammadreza Hashemian
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2912 3100
Email
iran.criticalcare@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Masih Daneshvari Hospital
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Masih Daneshvari Hospital
Full name of responsible person
Dr Seyyed Mohammadreza Hashemian
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 27123101
Fax
Email
iran.criticalcare@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Masih Daneshvari center
Full name of responsible person
Dr Seyyed Mohammadreza Hashemian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2912 3100
Fax
Email
Iran.criticalcare@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Masih Daneshvari Center
Full name of responsible person
Dr Somayeh Akhavan
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2912 3100
Fax
Email
SOMAYEHAKHAVAN30@GMAIL.COM
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
to consider ethical problem
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available