Reformative Versus Single Step Dilation Percutaneous Dilatational Tracheostomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-01

Study Completion Date

2017-02-15

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Respiratory Failure Respiratory Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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sd-PDT group

The investigators applied the traditional standard dilation technique when operating tracheostomy on the standard group.

Group Type PLACEBO_COMPARATOR

reformative dilation technique

Intervention Type PROCEDURE

reformative dilation technique was used when operating tracheostomy

re-PDT group

The investigators applied the reformative dilation technique when operating tracheostomy on the re-PDT group.

Group Type EXPERIMENTAL

reformative dilation technique

Intervention Type PROCEDURE

reformative dilation technique was used when operating tracheostomy

Interventions

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reformative dilation technique

reformative dilation technique was used when operating tracheostomy

Intervention Type PROCEDURE

Other Intervention Names

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reformative tracheostomy

Eligibility Criteria

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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.

Minimum Eligible Age

44 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No