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Trial registered on ANZCTR


Registration number
ACTRN12611000342910
Ethics application status
Approved
Date submitted
31/03/2011
Date registered
1/04/2011
Date last updated
1/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Percutaneous Dilatational Versus Conventional Surgical Tracheostomy in Intensive Care Patients.
Scientific title
A prospective randomized trial of percutaneous dilatational versus conventional surgical tracheostomy in intensive care patients regarding the operative time, the mean size of tracheostomy tube, intra-operative bleeding and postoperative infection .
Secondary ID [1] 259888 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tracheostomy for airway protection 265484 0
Condition category
Condition code
Respiratory 265634 265634 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients were subjected to general anesthesia and orotracheal intubation with continuous monitoring arterial blood gasses , blood pressure, electrocardiography , pulse oximetry , intra operative blood loss and record to tracheostomy tube size. Percutaneous dilatational tracheostomy (PDT) was done using the Griggs’ guide wire dilating forceps technique (through trans cervical insertion and the trachea cannulated with 14-G cannula between the second, or the second and third tracheal rings and J guide wire inserted followed by blunt dilation.This procedure was successful n the PDT group and was performed as a single intervention for each patient with a mean operative time of 20 minutes.
Intervention code [1] 264311 0
Treatment: Devices
Intervention code [2] 264322 0
Treatment: Surgery
Comparator / control treatment
Conventional surgical tracheostomy (CST) patients group subjected to horizontal skin incision midway between the sternal notch and cricoid cartilage, , revealing the thyroid isthmus and then the cricoid cartilage identified , cricoid hook used to pull the trachea superiorly finally insert suitable tracheostomy tube. This procedure was successful in all patients and was performed as a single intervention for each patient with a mean operative time of 19.3 minutes
Control group
Active

Outcomes
Primary outcome [1] 262425 0
Mortality rate.
Mortality related to both tracheostomy techniques was only considered during the first postoperative week.
Timepoint [1] 262425 0
1 week
Secondary outcome [1] 273749 0
Operative time
Timepoint [1] 273749 0
Intraoperative
Secondary outcome [2] 273750 0
Mean size of tracheostomy tube
Timepoint [2] 273750 0
Intraoperative
Secondary outcome [3] 273751 0
intra-operative bleeding
Timepoint [3] 273751 0
Intraoperative
Secondary outcome [4] 273752 0
Postoperative infection was assessed by clinical examination of wounds
Timepoint [4] 273752 0
7 days

Eligibility
Key inclusion criteria
critically ill patients admitted to intensive care unite for prolonged intubation, airway protection or pulmonary hygiene .
Minimum age
32 Years
Maximum age
67 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with distorted anatomy, history of previous surgery at the neck , bleeding disorder, goiter , neck masses , unstable general condition or cervical spine trauma were excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3324 0
Egypt
State/province [1] 3324 0

Funding & Sponsors
Funding source category [1] 264774 0
Hospital
Name [1] 264774 0
Suez Canal University hospital
Address [1] 264774 0
Faculty of medicine, Suez Canal University, Egypt
Country [1] 264774 0
Egypt
Primary sponsor type
Individual
Name
Tarek .F. Youssef
Address
Faculty of medicine, Suez Canal University, Egypt
Country
Egypt
Secondary sponsor category [1] 263889 0
Individual
Name [1] 263889 0
Aly Saber
Address [1] 263889 0
Port-Fouad general Hospital, Port-Fouad, Egypt.
Country [1] 263889 0
Egypt
Secondary sponsor category [2] 263897 0
None
Name [2] 263897 0
Address [2] 263897 0
Country [2] 263897 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Tracheostomy is usually performed in patients with difficult weaning from mechanical ventilation or some catastrophic neurologic insult. Percutaneous dilatational tracheostomy (PDT) is increasingly popular and has gained widespread acceptance in many ICU and trauma centers as a viable alternative approach.
64 critically ill patients admitted to intensive care unite subjected to tracheostomy and randomly divided into two groups; percutaneous dilatational tracheostomy (PDT) and conventional surgical tracheostomy (CST).Operations were performed by the surgical team in the university hospital, department of Otolaryngology, Faculty of medicine, Suez Canal University, Egypt from 1/2/2007 to 31/8/2010.
The aim was to compare the outcome of both techniques regarding mortality rate, intraoperative bleeding,the tracheostomy tube size and wound infection.
Conclusion: PDT technique is similar effective and safe as CST with low incidence of post operative complication.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32415 0
Address 32415 0
Country 32415 0
Phone 32415 0
Fax 32415 0
Email 32415 0
Contact person for public queries
Name 15662 0
Aly Saber
Address 15662 0
Port-Fouad general Hospital, Port-Fouad, Egypt.
Country 15662 0
Egypt
Phone 15662 0
+2/066/ 3406474
Fax 15662 0
Email 15662 0
alysaber54@gmail.com
Contact person for scientific queries
Name 6590 0
Aly Saber
Address 6590 0
Port-Fouad general Hospital, Port-Fouad, Egypt.
Country 6590 0
Egypt
Phone 6590 0
+2/066/3406474
Fax 6590 0
Email 6590 0
alysaber54@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary