A proposed novel ultrasound-guided percutaneous dilatational tracheostomy technique - the in-plane wire-in-needle approach: study design and rationale for multicenteric randomized controlled clinical trial
Keywords:Ultrasound guidance, Percutaneous dilatational tracheostomy, Out-of-plane approach, In-plane approach, Needle visibility, Safety, Efficacy
Background: The current evidence regarding the applications of Ultra Sound (US) in Percutaneous Dilatational Tracheostomy (PDT) is encouraging. US guided PDT (US-PDT) has recently been recommended in difficult cases and is given a preference compared to bronchoscope guided PDT. The question on the difference in safety and efficacy of the different approaches in US-PDT (with or without the use of any technique to improve needle visualization) during US-PDT and whether it is likely to make a difference needs to be answered.
Methods: Literatures examining the different US-PDT approaches as well as whether any technique to improving needle visualization that has been used during US-PDT in MEDLINE, PubMed, EMBAS E, and the Cochrane Central Register of Controlled Trials were searched for in an attempt to answer the two questions raised. No study has yet compared the in plane to the out of plane approach for US-PDT nor looked at improving needle visualization during US-PDT. This raised the need for a clinical trial looking at the difference between the different US-PDT approaches with or without ways to improve needle visualization during US-PDT.
Results: Utilizing the best available evidence in US guided procedures in the Intensive Care Units (ICU), we proposed a study design that we think is likely to make a difference in US-PDT practice. The study is designed to assess the safety and efficacy of US guided PDT using the in-plane (I.P.) approach enhanced with the use of Wire-in-needle approach (W.I.N.A) and rocking motion of the transducer compared to the traditional out-of-plane approach without W.I.N.A.
Conclusions: The proposed (In-plane Wire-In-needle approach = I.P.W.I.N.A) as a potential to be a standard of care in US-PDT has its own limitations. Its safety, efficacy and feasibility in Randomized Controlled Clinical Trials research settings needs to be tested and verified.
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