In this study, morbidity and mortality were compared for two methods mini-surgical tracheostomy and standard percutaneous dilational tracheostomy. In this study, 320 patients were enrolled, 160 patients were treated by mini-surgical tracheostomy and 160 patients by standard percutaneous dilatational tracheostomy .
These methods were performed on ICU bed. In mini-surgical method unlike standard percutaneous dilational tracheostomy, two layers are separated from each other along one vertical and one horizontal incision, and then dissection. Throughout all stages of the procedure full monitoring of Electrocardiography, pulse oximetery and blood pressure were done. Primary outcome was amount of bleeding and length of stay in intensive care unit also were compared in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015040120592N3
Registration date:2015-04-20, 1394/01/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-04-20, 1394/01/31
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
None
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Success and Complications in Mini-surgical and Standard Methods in ICU patients at Masih Daneshvari Hospital
Public title
The effect of surgery type on bleeding in hospitalized patients in intensivel care unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
Guardian consent;
age between 17 through 75;
Placed under mechanical ventilation for at least 7 days from the Endotracheal Tube and require mechanical ventilation
exclusion criteria:
Patients with unstable cervical vertebrae;
Interstate and severe disease in the study intervention;
Severe coagulopathy;
Surgical wound infection
Age
From 17 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
320
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Velenjak, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Postal code
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
None
Health conditions studied
1
Description of health condition studied
Mechanical Ventilator
ICD-10 code
Z51.8
ICD-10 code description
Other specified medical care
Primary outcomes
1
Description
Bleeding
Timepoint
Start of study
Method of measurement
Observation
Secondary outcomes
1
Description
Time of Surgery
Timepoint
Start of Study
Method of measurement
Observation
2
Description
Decrease of O2saturation
Timepoint
Start of Study
Method of measurement
Observation
Intervention groups
1
Description
Intervention group (Mini-surgical method): All anticoagulants stopped at least 12 hours before the procedure or after indicated correction of coagulopathy. Patient lied supinely on the bed. following prepping and draping the cricoid is palpated and a 2-cm vertical skin incision made 1 cm below the cricoid cartilage.Attending physician stood at the head of the bed and the assistant fellow stood at the right side of patient. Our modified PDT technique, msPDT, utilized a Tracoe® experc dilatation set.
Category
Treatment - Surgery
2
Description
control group:
All STs were performed in the operative suite using standard techniques described elsewhere.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Seyed Mohammad Reza Hashemian
Street address
Masih Daneshvari Hospital, Dara'abad Street, Niavaran Street, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Sadoghi
Street address
Shahid Beheshti University of Medical Sciences, Velenjak, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Masih Daneshvari Hospital
Full name of responsible person
Seyed Mohammad Reza Hashemian
Position
Associate Professor
Other areas of specialty/work
Street address
Masih Daneshvari Hospital,Darabad,Shahid Bahonar Street,Tehran,iran