NCT02656719

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

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

August 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

1.1 years

First QC Date

January 5, 2016

Last Update Submit

March 9, 2020

Conditions

Tracheostomy Complications

Keywords

tracheostomycomplicationsultrasoundbronchoscopy

Outcome Measures

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

    During percutaneous tracheostomy an expected average time 20 minutes

Secondary Outcomes (7)

  • procedure time

    during percutaneous tracheostomy ( average expected time 20 minutes)

  • Pneumothorax

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

  • Tracheal posterior wall injury

    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

  • Cardiorespiratory arrest

    during percutaneous tracheostomy an expected average of 20 minutes

  • +2 more secondary outcomes

Other Outcomes (1)

  • Hypoxemia

    During percutaneous tracheostomy an expected average of 20 minutes

Study Arms (2)

Ultrasound

EXPERIMENTAL

Ultrasound guided percutaneous tracheostomy

Device: Ultrasound guided percutaneous tracheostomy

Bronchoscopy

ACTIVE COMPARATOR

Bronchoscopy guided percutaneous tracheostomy

Device: Bronchoscopy guided percutaneous tracheostomy

Interventions

Ultrasound guided percutaneous tracheostomyDEVICE

Ultrasound guided percutaneous tracheostomy

Ultrasound
Bronchoscopy guided percutaneous tracheostomyDEVICE

Bronchoscopy guided percutaneous tracheostomy

Bronchoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All intubated and mechanically ventilated patients indicated for a tracheostomy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 25859079BACKGROUND

  • 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.

    PMID: 25306240BACKGROUND

  • 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.

    PMID: 19680824BACKGROUND

Study Officials

  • Aykut Saritas, MD

    İzmir Tepecik Training and Research Hospital

    PRINCIPAL INVESTIGATOR

  • muhammed murat kurnaz, MD

    Prof.Dr.A.İlhan Ozdemir State hospital Giresun

    STUDY CHAIR

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
principal investigator

Study Record Dates

First Submitted

January 5, 2016

First Posted

January 15, 2016

Study Start

August 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

March 10, 2020

Record last verified: 2020-03