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Clinical Trials/NCT02656719
NCT02656719
Completed
Not Applicable

Comparison Between Bronchoscopy and Real- Time Ultrasound Guided Percutaneous Dilatational Tracheostomy for Safety, Complications and Efficiency in Critically Ill Patient

Aykut Saritas0 sites80 target enrollmentAugust 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tracheostomy Complications
Sponsor
Aykut Saritas
Enrollment
80
Primary Endpoint
procedure failure of ultrasound to provide this anatomical information and ease of perform
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Trial is a randomized study to compare between ultrasound guided percutaneous tracheostomy and bronchoscopy guided percutaneous tracheostomy.

Detailed Description

Trial is a randomized study to compare between ultrasound guided percutaneous tracheostomy and bronchoscopy guided percutaneous tracheostomy. Patients will be randomly assigned to be submitted to evaluate safety, complication rates, easy to perform , clinical outcomes and effectivity.

Registry
clinicaltrials.gov
Start Date
August 2015
End Date
September 2016
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Aykut Saritas
Responsible Party
Sponsor Investigator
Principal Investigator

Aykut Saritas

principal investigator

Tepecik Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • All intubated and mechanically ventilated patients indicated for a tracheostomy

Exclusion Criteria

  • Patients with tracheal or neck abnormalities, soft tissue infection in the neck, neck surgery history, oxygenation problems , coagulation disorders or coagulation parameter changes and those requiring urgent or surgery patients unable to provide informed consent.

Outcomes

Primary Outcomes

procedure failure of ultrasound to provide this anatomical information and ease of perform

Time Frame: During percutaneous tracheostomy an expected average time 20 minutes

occurence of a major complications: bleeding, subcutaneous emphysema, oesophageal perforation, number of applied needle interventions, procedure duration, cardiorespiratory arrest

Secondary Outcomes

  • Pneumothorax(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
  • Accidental decannulation(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
  • Minor bleeding(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
  • procedure time(during percutaneous tracheostomy ( average expected time 20 minutes))
  • Tracheal posterior wall injury(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
  • Major bleeding(During the procedure an expected average of 20 minutes)
  • Cardiorespiratory arrest(during percutaneous tracheostomy an expected average of 20 minutes)

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