Skip to main content
OpenTrials
Completed

NCT Number: NCT02656719

Comparison Between Bronchoscopy and Real- Time Ultrasound Guided Percutaneous Tracheostomy

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tracheostomy Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound guided percutaneous tracheostomy

Device

Ultrasound guided percutaneous tracheostomy

Bronchoscopy guided percutaneous tracheostomy

Device

Bronchoscopy guided percutaneous tracheostomy

Primary outcomes

  1. 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

  1. procedure time

    Time frame: during percutaneous tracheostomy ( average expected time 20 minutes)

    the procedure duration was taken as the time that elapsed from the placement of the needle to the placement of the tracheostomy cannula.

  2. Pneumothorax

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

    Pneumothorax due to the percutaneous tracheostomy detected by clinical examination during the procedure or chest x-ray after the procedure.

  3. Tracheal posterior wall injury

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

    Tracheal posterior wall injury as detected by bronchoscopy after the procedure

  4. Accidental decannulation

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

    Accidental decannulation after the procedure during Hospital stay

  5. Cardiorespiratory arrest

    Time frame: during percutaneous tracheostomy an expected average of 20 minutes

    Cardiorespiratory arrest due to percutaneous tracheostomy

  6. Minor bleeding

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

    Haemorrhage that could not be stopped by sponge wrapping the stoma after the procedure and/or blood coming with aspiration inside the tracheostomy tube was defined as minor bleeding

  7. Major bleeding

    Time frame: During the procedure an expected average of 20 minutes

    Continuous haemorrhage from the stoma and/or from the trachea with aspiration despite compresses was defined as a major haemorrhage.

Other outcomes

  1. Hypoxemia

    Time frame: During percutaneous tracheostomy an expected average of 20 minutes

    Drop in peripheral oxygen saturation < 90% for more than 2 minutes as measured by pulse oximeter during the procedure

Sponsors and collaborators

Lead sponsor

Aykut Saritas

Other

Collaborators

  • Prof.Dr.A.İlhan Özdemir State Hospital

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 15, 2016
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.