NCT02754921

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
Last Updated

April 28, 2016

Status Verified

April 1, 2016

Enrollment Period

2.9 years

First QC Date

April 25, 2016

Last Update Submit

April 27, 2016

Conditions

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

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Ultra-perc

EXPERIMENTAL
Procedure: percutaneous dilatational tracheostomy using Ultra-Perc

Ciaglia Blue Dolphin

EXPERIMENTAL
Procedure: Percutaneous dilatational tracheostomy using Ciaglia Blue Dolphin

Interventions

percutaneous dilatational tracheostomy using Ultra-PercPROCEDURE

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

Ultra-perc
Percutaneous dilatational tracheostomy using Ciaglia Blue DolphinPROCEDURE

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

Ciaglia Blue Dolphin

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • sepsis
  • cerebrovascular accidents
  • cervical cord injury
  • traumatic brain injury
  • post arrest and chronic obstructive pulmonary disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cianchi G, Zagli G, Bonizzoli M, Batacchi S, Cammelli R, Biondi S, Spina R, Peris A. Comparison between single-step and balloon dilatational tracheostomy in intensive care unit: a single-centre, randomized controlled study. Br J Anaesth. 2010 Jun;104(6):728-32. doi: 10.1093/bja/aeq087. Epub 2010 Apr 21.

    PMID: 20413380RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 25, 2016

First Posted

April 28, 2016

Study Start

January 1, 2013

Primary Completion

December 1, 2015

Last Updated

April 28, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will share