Comparison Between Bronchoscopy and Real- Time Ultrasound Guided Percutaneous Tracheostomy

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

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

Study Overview

• Status: Completed
• Conditions: Tracheostomy Complications
• Intervention / Treatment: Device: Ultrasound guided percutaneous tracheostomy; Device: 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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound; Ultrasound guided percutaneous tracheostomy	Device: Ultrasound guided percutaneous tracheostomy; Ultrasound guided percutaneous tracheostomy
Active Comparator: Bronchoscopy; Bronchoscopy guided percutaneous tracheostomy	Device: Bronchoscopy guided percutaneous tracheostomy; Bronchoscopy guided percutaneous tracheostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Aykut Saritas
• Collaborators: Prof.Dr.A.İlhan Özdemir State Hospital
• Investigators: Principal Investigator: Aykut Saritas, MD, Izmir Tepecik Training and Research Hospital; Study Chair: muhammed murat kurnaz, MD, Prof.Dr.A.İlhan Ozdemir State hospital Giresun

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: January 5, 2016
• First Submitted That Met QC Criteria: January 14, 2016
• First Posted (Estimate): January 15, 2016

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: ultrasound; bronchoscopy; complications; tracheostomy
• Other Study ID Numbers: 2014-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED