An interventional study of Ultrasound guided percutaneous tracheostomy and Bronchoscopy guided percutaneous tracheostomy in Tracheostomy Complications, sponsored by Aykut Saritas. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-10.
Sponsored by Aykut Saritas · Not applicable, Interventional, and Treatment
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.
This is the only study on the registry with Aykut Saritas as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ultrasound guided percutaneous tracheostomy
Device: Ultrasound guided percutaneous tracheostomy
Bronchoscopy guided percutaneous tracheostomy
Device: Bronchoscopy guided percutaneous tracheostomy
Ultrasound guided percutaneous tracheostomy
Bronchoscopy guided percutaneous tracheostomy
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
Time frame: During percutaneous tracheostomy an expected average time 20 minutes
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.
Time frame: during percutaneous tracheostomy ( average expected time 20 minutes)
Pneumothorax
Pneumothorax due to the percutaneous tracheostomy detected by clinical examination during the procedure or chest x-ray after the procedure.
Time frame: 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
Time frame: 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
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Cardiorespiratory arrest
Cardiorespiratory arrest due to percutaneous tracheostomy
Time frame: 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
Time frame: 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.
Time frame: During the procedure an expected average of 20 minutes
Hypoxemia
Drop in peripheral oxygen saturation \< 90% for more than 2 minutes as measured by pulse oximeter during the procedure
Time frame: During percutaneous tracheostomy an expected average of 20 minutes
No study locations are listed for this record.
Plan to share: Undecided
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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