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CompletedNCT02656719Updated Mar 10, 2020

Comparison Between Bronchoscopy and Real- Time Ultrasound Guided Percutaneous Tracheostomy

An interventional study of Ultrasound guided percutaneous tracheostomy and Bronchoscopy guided percutaneous tracheostomy in Tracheostomy Complications, sponsored by Aykut Saritas. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-10.

Sponsored by Aykut Saritas · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Tracheostomy Complications

Keywords

  • tracheostomy
  • complications
  • ultrasound
  • bronchoscopy
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In context

Lead sponsor

This is the only study on the registry with Aykut Saritas as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All intubated and mechanically ventilated patients indicated for a tracheostomy

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Ultrasound

    Ultrasound guided percutaneous tracheostomy

    Device: Ultrasound guided percutaneous tracheostomy

  • Active comparator
    Bronchoscopy

    Bronchoscopy guided percutaneous tracheostomy

    Device: Bronchoscopy guided percutaneous tracheostomy

Interventions

  • DeviceUltrasound guided percutaneous tracheostomy

    Ultrasound guided percutaneous tracheostomy

  • DeviceBronchoscopy guided percutaneous tracheostomy

    Bronchoscopy guided percutaneous tracheostomy

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What researchers measure

Primary outcomes

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

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

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

Secondary outcomes

  1. procedure time

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

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

  2. Pneumothorax

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

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

  3. Tracheal posterior wall injury

    Tracheal posterior wall injury as detected by bronchoscopy after the procedure

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

  4. Accidental decannulation

    Accidental decannulation after the procedure during Hospital stay

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

  5. Cardiorespiratory arrest

    Cardiorespiratory arrest due to percutaneous tracheostomy

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

  6. Minor bleeding

    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

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

  7. Major bleeding

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

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

Other outcomes

  1. Hypoxemia

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

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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Ravi PR, Vijay MN. Real time ultrasound-guided percutaneous tracheostomy: Is it a better option than bronchoscopic guided percutaneous tracheostomy? Med J Armed Forces India. 2015 Apr;71(2):158-64. doi: 10.1016/j.mjafi.2015.01.013. Epub 2015 Mar 12. PubMed 25859079 ↗
  • Gobatto AL, Besen BA, Tierno PF, Mendes PV, Cadamuro F, Joelsons D, Melro L, Park M, Malbouisson LM. Comparison between ultrasound- and bronchoscopy-guided percutaneous dilational tracheostomy in critically ill patients: a retrospective cohort study. J Crit Care. 2015 Feb;30(1):220.e13-7. doi: 10.1016/j.jcrc.2014.09.011. Epub 2014 Sep 22. PubMed 25306240 ↗
  • Flint AC, Midde R, Rao VA, Lasman TE, Ho PT. Bedside ultrasound screening for pretracheal vascular structures may minimize the risks of percutaneous dilatational tracheostomy. Neurocrit Care. 2009 Dec;11(3):372-6. doi: 10.1007/s12028-009-9259-z. Epub 2009 Aug 13. PubMed 19680824 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02656719
Lead sponsor
Aykut Saritas
Collaborators
Prof.Dr.A.İlhan Özdemir State Hospital
Responsible party
Aykut Saritas (principal investigator, Tepecik Training and Research Hospital) — Sponsor-investigator
First posted
Jan 15, 2016
Start date
Aug 2015
Primary completion
Sep 2016
Completion
Sep 2016
Last update
Mar 10, 2020

Study contacts

Aykut Saritas, MD
principal investigator · İzmir Tepecik Training and Research Hospital
muhammed murat kurnaz, MD
study chair · Prof.Dr.A.İlhan Ozdemir State hospital Giresun

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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