Percutaneous Dilatational Tracheostomy: Ultra-perc Versus Ciaglia Blue Dolphin

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02754921

Enrollment

Registered

2016-04-28

Start date

2013-01-31

Completion date

Unknown

Last updated

2016-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDUREpercutaneous dilatational tracheostomy using Ultra-Perc

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

PROCEDUREPercutaneous dilatational tracheostomy using Ciaglia Blue Dolphin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026