Percutaneous Dilatational Tracheostomy: Ultra-perc Versus Ciaglia Blue Dolphin

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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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

percutaneous dilatational tracheostomy using Ultra-Perc

Procedure

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

Percutaneous dilatational tracheostomy using Ciaglia Blue Dolphin

Procedure

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

Primary outcomes

Procedure difficulties including difficult dilatation, difficult tube insertion, failed tube insertion, false passage and tracheal stoma over dilatation.

Time frame: within 2 years
Procedure complications including cardiac arrest, pneumothorax, pneumomediastinum, subcutaneous emphysema, hemorrhage and lung atelectasis.

Time frame: within 2 years

Sponsors and collaborators

Lead sponsor

Mohamed Sayed Mohamed Abbas

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2015
First posted: Apr 28, 2016
Registry last updated: Apr 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.