Reformative Versus Single Step Dilation Percutaneous Dilatational Tracheostomy

Study Overview
=================
Brief Summary
-----------------
Percutaneous dilatational tracheostomy (PDT), especially single-step dilatational tracheostomy (sd-PDT), is now frequently preferred to surgical tracheostomy. Occasionally, it needs a second dilation maneuver .Dissection of the deep cervical fascia during PDT, known as reformative PDT (re-PDT), may facilitate the procedure. This study was designed to compare re-PDT with sd-PDT in ICU patients

Detailed Description
-----------------
Percutaneous dilatational tracheostomy (PDT) is a popular airway management technique in the intensive care unit (ICU).Occasionally the first dilation may be challenging when using Ciaglia and colleagues' method, and a second dilation may be needed to insert the tracheostomy tube. In these circumstances, potentially life-threatening complications, such as hemorrhage and hypoxia, may arise. The investigators found the reasons for difficulty in achieving smooth dilation of the stoma.The investigators compared the traditional method with the improved method.

Official Title
-----------------
Reformative Versus Single Step Dilation Percutaneous Dilatational Tracheostomy: a Randomized Trial

Conditions
-----------------
Respiratory Failure, Respiratory Depression

Intervention / Treatment
-----------------
* Procedure: reformative dilation technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥18 years; requirement for long-term mechanical ventilation; failure of weaning from mechanical ventilation. Exclusion Criteria: age <18 years; pre-existing infection at the tracheostomy site; pre-existing malignancy at the tracheostomy site; difficulty in identifying the anatomic landmarks; unstable cervical spine fracture; international normalized ratio (INR) >2; platelet count <50 000 mm3.

Ages Eligible for Study
-----------------
Minimum Age: 44 Years
Maximum Age: 89 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: sd-PDT group<br>The investigators applied the traditional standard dilation technique when operating tracheostomy on the standard group. | Procedure: reformative dilation technique<br>* reformative dilation technique was used when operating tracheostomy<br>* Other names: reformative tracheostomy;|
| Experimental: re-PDT group<br>The investigators applied the reformative dilation technique when operating tracheostomy on the re-PDT group. | Procedure: reformative dilation technique<br>* reformative dilation technique was used when operating tracheostomy<br>* Other names: reformative tracheostomy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Force(newton) | Force refers to the force needed to dilate the airway and measured by force gauge | Intraoperative (Force was measured the exact moment when investigators insert the'J' guidewire) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time(seconds) | Time refers to the time needed to finish the whole step from tracheal puncture to tracheal tube placement | Time was measured from tracheal puncture to tracheal tube placement, 180 seconds maxime | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tracheostomy，fascia，force gauge