Comparison Between Bronchoscopy and Real- Time Ultrasound Guided Percutaneous Tracheostomy
Study Details
Study Description
Brief Summary
Trial is a randomized study to compare between ultrasound guided percutaneous tracheostomy and bronchoscopy guided percutaneous tracheostomy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ultrasound Ultrasound guided percutaneous tracheostomy |
Device: Ultrasound guided percutaneous tracheostomy
Ultrasound guided percutaneous tracheostomy
|
| Active Comparator: Bronchoscopy Bronchoscopy guided percutaneous tracheostomy |
Device: Bronchoscopy guided percutaneous tracheostomy
Bronchoscopy guided percutaneous tracheostomy
|
Outcome Measures
Primary Outcome Measures
- procedure failure of ultrasound to provide this anatomical information and ease of perform [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 Outcome Measures
- procedure time [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.
- Pneumothorax [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.
- Tracheal posterior wall injury [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
- Accidental decannulation [Participants will be followed for the duration of hospital stay, an expected average of 4 weeks]
Accidental decannulation after the procedure during Hospital stay
- Cardiorespiratory arrest [during percutaneous tracheostomy an expected average of 20 minutes]
Cardiorespiratory arrest due to percutaneous tracheostomy
- Minor bleeding [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
- Major bleeding [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 Outcome Measures
- Hypoxemia [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
Eligibility Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Aykut Saritas
- Prof.Dr.A.İlhan Özdemir State Hospital
Investigators
- Principal Investigator: Aykut Saritas, MD, İzmir Tepecik Training and Research Hospital
- Study Chair: muhammed murat kurnaz, MD, Prof.Dr.A.İlhan Ozdemir State hospital Giresun
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 2014-1