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Comparison Between Bronchoscopy and Real- Time Ultrasound Guided Percutaneous Tracheostomy

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ClinicalTrials.gov Identifier: NCT02656719
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : October 18, 2016
Sponsor:
Collaborator:
Prof.Dr.A.İlhan Özdemir State Hospital
Information provided by (Responsible Party):
Aykut Saritas, Tepecik Training and Research Hospital

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

Condition or disease Intervention/treatment Phase
Tracheostomy Complications Device: Ultrasound guided percutaneous tracheostomy Device: Bronchoscopy guided percutaneous tracheostomy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Bronchoscopy and Real- Time Ultrasound Guided Percutaneous Dilatational Tracheostomy for Safety, Complications and Efficiency in Critically Ill Patient
Study Start Date : August 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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




Primary Outcome Measures :
  1. procedure failure of ultrasound to provide this anatomical information and ease of perform [ Time Frame: 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 :
  1. procedure time [ Time Frame: 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.

  2. Pneumothorax [ Time Frame: 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.

  3. Tracheal posterior wall injury [ Time Frame: 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

  4. Accidental decannulation [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
    Accidental decannulation after the procedure during Hospital stay

  5. Cardiorespiratory arrest [ Time Frame: during percutaneous tracheostomy an expected average of 20 minutes ]
    Cardiorespiratory arrest due to percutaneous tracheostomy

  6. Minor bleeding [ Time Frame: 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

  7. Major bleeding [ Time Frame: 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.


Other Outcome Measures:
  1. Hypoxemia [ Time Frame: During percutaneous tracheostomy an expected average of 20 minutes ]
    Drop in peripheral oxygen saturation < 90% for more than 2 minutes as measured by pulse oximeter during the procedure



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656719


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

Publications:
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Responsible Party: Aykut Saritas, principal investigator, Tepecik Training and Research Hospital
ClinicalTrials.gov Identifier: NCT02656719     History of Changes
Other Study ID Numbers: 2014-1
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Aykut Saritas, Tepecik Training and Research Hospital:
tracheostomy
complications
ultrasound
bronchoscopy

Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes