Percutaneous Dilatational Tracheostomy: Ultra-perc Versus Ciaglia Blue Dolphin

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ultra-perc

Group Type EXPERIMENTAL

percutaneous dilatational tracheostomy using Ultra-Perc

Intervention Type PROCEDURE

Procedure difficulties and complications faced while doing percutaneous dilatational tracheostomy using Ultra-Perc

Ciaglia Blue Dolphin

Group Type EXPERIMENTAL

Percutaneous dilatational tracheostomy using Ciaglia Blue Dolphin

Intervention Type PROCEDURE

Procedure difficulties and complications faced while doing percutaneous dilatational tracheostomy using Ciaglia Blue Dolphin

Interventions

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percutaneous dilatational tracheostomy using Ultra-Perc

Procedure difficulties and complications faced while doing percutaneous dilatational tracheostomy using Ultra-Perc

Intervention Type PROCEDURE

Percutaneous dilatational tracheostomy using Ciaglia Blue Dolphin

Procedure difficulties and complications faced while doing percutaneous dilatational tracheostomy using Ciaglia Blue Dolphin

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No