Comparison Between Bronchoscopy and Real- Time Ultrasound Guided Percutaneous Tracheostomy

Tracheostomy Complications Clinical Trial

Official title:

Comparison Between Bronchoscopy and Real- Time Ultrasound Guided Percutaneous Dilatational Tracheostomy for Safety, Complications and Efficiency in Critically Ill Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656719
• Other study ID #: 2014-1
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: September 2016

Study information

• Verified date: March 2020
• Source: Tepecik Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Trial is a randomized study to compare between ultrasound guided percutaneous tracheostomy and bronchoscopy guided percutaneous tracheostomy.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tracheostomy Complications

Intervention

Device:
• Ultrasound guided percutaneous tracheostomy
Ultrasound guided percutaneous tracheostomy
• Bronchoscopy guided percutaneous tracheostomy
Bronchoscopy guided percutaneous tracheostomy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Aykut Saritas	Prof.Dr.A.Ilhan Özdemir State Hospital

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Secondary	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)
Secondary	Pneumothorax	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
Secondary	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
Secondary	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
Secondary	Cardiorespiratory arrest	Cardiorespiratory arrest due to percutaneous tracheostomy	during percutaneous tracheostomy an expected average of 20 minutes
Secondary	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
Secondary	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