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| Name | Class |
|---|---|
| Prof.Dr.A.İlhan Özdemir State Hospital | OTHER |
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Trial is a randomized study to compare between ultrasound guided percutaneous tracheostomy and bronchoscopy guided percutaneous tracheostomy.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound | Experimental | Ultrasound guided percutaneous tracheostomy |
|
| Bronchoscopy | Active Comparator | Bronchoscopy guided percutaneous tracheostomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound guided percutaneous tracheostomy | Device | Ultrasound guided percutaneous tracheostomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | during percutaneous tracheostomy ( average expected time 20 minutes) |
| Pneumothorax |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoxemia | Drop in peripheral oxygen saturation < 90% for more than 2 minutes as measured by pulse oximeter during the procedure | During percutaneous tracheostomy an expected average of 20 minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25859079 | Background | 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. | |
| 25306240 | Background | 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. |
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| Bronchoscopy guided percutaneous tracheostomy | Device | Bronchoscopy guided percutaneous tracheostomy |
|
Pneumothorax due to the percutaneous tracheostomy detected by clinical examination during the procedure or chest x-ray after the procedure.
| Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Tracheal posterior wall injury | Tracheal posterior wall injury as detected by bronchoscopy after the procedure | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Accidental decannulation | Accidental decannulation after the procedure during Hospital stay | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Cardiorespiratory arrest | Cardiorespiratory arrest due to percutaneous tracheostomy | during percutaneous tracheostomy an expected average of 20 minutes |
| 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 | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Major bleeding | Continuous haemorrhage from the stoma and/or from the trachea with aspiration despite compresses was defined as a major haemorrhage. | During the procedure an expected average of 20 minutes |
| 19680824 | Background | 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. |