Clinical trial NCT02656719: Comparison Between Bronchoscopy and Real- Time Ultrasound Guided Percutaneous Tracheostomy
Official title: Comparison Between Bronchoscopy and Real- Time Ultrasound Guided Percutaneous Dilatational Tracheostomy for Safety, Complications and Efficiency in Critically Ill Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheostomy Complications
Keywords: tracheostomy
complications
ultrasound
bronchoscopy
Lead sponsor: Tepecik Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Prof.Dr.A.İlhan Özdemir State Hospital
First posted: 2016-01-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: procedure failure of ultrasound to provide this anatomical information and ease of perform
timeFrame: During percutaneous tracheostomy an expected average time 20 minutes
Secondary outcomes:
measure: procedure time
timeFrame: during percutaneous tracheostomy ( average expected time 20 minutes)
measure: Pneumothorax
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Tracheal posterior wall injury
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Accidental decannulation
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Cardiorespiratory arrest
timeFrame: during percutaneous tracheostomy an expected average of 20 minutes
measure: Minor bleeding
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Major bleeding
timeFrame: During the procedure an expected average of 20 minutes
Other outcomes:
measure: Hypoxemia
timeFrame: During percutaneous tracheostomy an expected average of 20 minutes
Locations:
Study officials:
affiliation: İzmir Tepecik Training and Research Hospital
name: Aykut Saritas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Prof.Dr.A.İlhan Ozdemir State hospital Giresun
name: muhammed murat kurnaz, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.