Comparison Between Bronchoscopy and Real- Time Ultrasound Guided Percutaneous Tracheostomy

Not Applicable

Completed

• Conditions: Tracheostomy Complications
• Interventions: Device: Ultrasound guided percutaneous tracheostomy; Device: Bronchoscopy guided percutaneous tracheostomy

• Registration Number: NCT02656719
• Lead Sponsor: Aykut Saritas

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2016-01-05
• Study First Submitted QC: 2016-01-14
• Study First Posted: 2016-01-15
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound	Ultrasound guided percutaneous tracheostomy	Ultrasound guided percutaneous tracheostomy
Bronchoscopy	Bronchoscopy guided percutaneous tracheostomy	Bronchoscopy guided percutaneous tracheostomy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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
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
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.
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
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.
Cardiorespiratory arrest	during percutaneous tracheostomy an expected average of 20 minutes	Cardiorespiratory arrest due to percutaneous tracheostomy