Percutaneous Dilatational Tracheostomy: Ultra-perc Versus Ciaglia Blue Dolphin

M

Mohamed Sayed Mohamed Abbas

Status

Completed

Conditions

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

Treatments

Procedure: Percutaneous dilatational tracheostomy using Ciaglia Blue Dolphin
Procedure: percutaneous dilatational tracheostomy using Ultra-Perc

Study type

Interventional

Funder types

Other

Identifiers

NCT02754921
MSAT-2

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

20+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Ultra-perc
Experimental group
Treatment:
Procedure: percutaneous dilatational tracheostomy using Ultra-Perc
Ciaglia Blue Dolphin
Experimental group
Treatment:
Procedure: Percutaneous dilatational tracheostomy using Ciaglia Blue Dolphin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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