Percutaneous Dilatational Tracheostomy: Ultra-perc Versus Ciaglia Blue Dolphin

April 27, 2016 updated by: Mohamed Sayed Mohamed Abbas

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ultra-perc
Procedure: percutaneous dilatational tracheostomy using Ultra-Perc
Procedure difficulties and complications faced while doing percutaneous dilatational tracheostomy using Ultra-Perc
EXPERIMENTAL: Ciaglia Blue Dolphin
Procedure: Percutaneous dilatational tracheostomy using Ciaglia Blue Dolphin
Procedure difficulties and complications faced while doing percutaneous dilatational tracheostomy using Ciaglia Blue Dolphin

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohamed Sayed Mohamed Abbas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

April 25, 2016

First Submitted That Met QC Criteria

April 27, 2016

First Posted (ESTIMATE)

April 28, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

April 28, 2016

Last Update Submitted That Met QC Criteria

April 27, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • MSAT-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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