Reformative Versus Single Step Dilation Percutaneous Dilatational Tracheostomy

The First Affiliated Hospital with Nanjing Medical University46 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Respiratory Failure Respiratory Depression

Interventions

reformative dilation techniquePROCEDURE

reformative dilation technique was used when operating tracheostomy

Eligibility

Sex: ALLMin age: 44 YearsMax age: 89 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Affliated Hospital wiht Nanjing Medical University

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

Force(newton)

Force refers to the force needed to dilate the airway and measured by force gauge

Time frame: Intraoperative (Force was measured the exact moment when investigators insert the'J' guidewire)

Secondary Outcomes

Time(seconds)

Time refers to the time needed to finish the whole step from tracheal puncture to tracheal tube placement

Time frame: Time was measured from tracheal puncture to tracheal tube placement, 180 seconds maxime

Data from ClinicalTrials.gov

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