Percutaneous Dilatational Tracheostomy: Ultra-perc Versus Ciaglia Blue Dolphin

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare Ultra-perc single stage dilator technique with Ciaglia Blue Dolphin ballon dilatation technique for intubated unweanable ICU patients with respect to procedure difficulties and complications.

Detailed Description
-----------------
The investigators conducted a prospective randomized trial to compare Ultra-perc single stage dilator technique (UP) and Ciaglia Blue Dolphin ballon dilatation technique (CBD) From January 2013 to December 2015. The investigators compared the two groups as regards Procedure difficulties including difficult dilatation, difficult tube insertion, failed tube insertion, false passage and tracheal stoma over dilatation. and Procedure complications including cardiac arrest, pneumothorax, pneumomediastinum, subcutaneous emphysema, hemorrhage and lung atelectasis.

Official Title
-----------------
Percutaneous Dilatational Tracheostomy: Ultra-perc Single Stage Dilator Technique Versus Ciaglia Blue Dolphin Ballon Dilatation Technique for Intubated Unweanable ICU Patients

Conditions
-----------------
ICU Patients Dependant on Mechanical Ventilation : Safest Mode of Performing Percutaneous Tracheostomy Among ICU Ventilated Unweanable Patients

Intervention / Treatment
-----------------
* Procedure: percutaneous dilatational tracheostomy using Ultra-Perc
* Procedure: Percutaneous dilatational tracheostomy using Ciaglia Blue Dolphin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sepsis cerebrovascular accidents cervical cord injury traumatic brain injury post arrest and chronic obstructive pulmonary disease Exclusion Criteria: patient or family refusal emergency tracheostomy distorted abnormal anatomy bleeding diathesis morbid obesity previous tracheostomy infected surgical site Adult respiratory distress syndrome patients requiring high positive end expiratory pressure and high oxygen demands

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultra-perc<br> | Procedure: percutaneous dilatational tracheostomy using Ultra-Perc<br>* Procedure difficulties and complications faced while doing percutaneous dilatational tracheostomy using Ultra-Perc<br>|
| Experimental: Ciaglia Blue Dolphin<br> | Procedure: Percutaneous dilatational tracheostomy using Ciaglia Blue Dolphin<br>* Procedure difficulties and complications faced while doing percutaneous dilatational tracheostomy using Ciaglia Blue Dolphin<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure difficulties including difficult dilatation, difficult tube insertion, failed tube insertion, false passage and tracheal stoma over dilatation. |  | within 2 years | 
| Procedure complications including cardiac arrest, pneumothorax, pneumomediastinum, subcutaneous emphysema, hemorrhage and lung atelectasis. |  | within 2 years |