Percutaneous Dilatational Tracheostomy: Ultra-perc Versus Ciaglia Blue Dolphin

Not Applicable

Completed

• Conditions: ICU Patients Dependant on Mechanical Ventilation : Safest Mode of Performing Percutaneous Tracheostomy Among ICU Ventilated Unweanable Patients
• Interventions: Procedure: Percutaneous dilatational tracheostomy using Ciaglia Blue Dolphin; Procedure: percutaneous dilatational tracheostomy using Ultra-Perc

• Registration Number: NCT02754921
• Lead Sponsor: Mohamed Sayed Mohamed Abbas

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2015-12
• Status Verified: 2016-04
• Study First Submitted: 2016-04-25
• Study First Submitted QC: 2016-04-27
• Last Update Submitted: 2016-04-27
• Study First Posted: 2016-04-28
• Last Update Posted: 2016-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ciaglia Blue Dolphin	Percutaneous dilatational tracheostomy using Ciaglia Blue Dolphin	-
Ultra-perc	percutaneous dilatational tracheostomy using Ultra-Perc	-

Primary Outcome Measures

Name	Time	Method
Procedure complications including cardiac arrest, pneumothorax, pneumomediastinum, subcutaneous emphysema, hemorrhage and lung atelectasis.	within 2 years
Procedure difficulties including difficult dilatation, difficult tube insertion, failed tube insertion, false passage and tracheal stoma over dilatation.	within 2 years