Reformative Versus Single Step Dilation Percutaneous Dilatational Tracheostomy

Respiratory Failure Clinical Trial

Official title:

Reformative Versus Single Step Dilation Percutaneous Dilatational Tracheostomy: a Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03141294
• Other study ID #: 2017-SR-078
• Status: Completed
• Phase: N/A
• First received: April 20, 2017
• Last updated: May 4, 2017
• Start date: July 1, 2012
• Est. completion date: February 15, 2017

Study information

• Verified date: May 2017
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Percutaneous dilatational tracheostomy (PDT), especially single-step dilatational tracheostomy (sd-PDT), is now frequently preferred to surgical tracheostomy. Occasionally, it needs a second dilation maneuver .Dissection of the deep cervical fascia during PDT, known as reformative PDT (re-PDT), may facilitate the procedure. This study was designed to compare re-PDT with sd-PDT in ICU patients

Description:

Percutaneous dilatational tracheostomy (PDT) is a popular airway management technique in the intensive care unit (ICU).Occasionally the first dilation may be challenging when using Ciaglia and colleagues' method, and a second dilation may be needed to insert the tracheostomy tube. In these circumstances, potentially life-threatening complications, such as hemorrhage and hypoxia, may arise. The investigators found the reasons for difficulty in achieving smooth dilation of the stoma.The investigators compared the traditional method with the improved method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 15, 2017
• Est. primary completion date: December 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 44 Years to 89 Years

Eligibility

Inclusion Criteria:

• age =18 years;

• requirement for long-term mechanical ventilation;

• failure of weaning from mechanical ventilation.

Exclusion Criteria:

• age <18 years;

• pre-existing infection at the tracheostomy site;

• pre-existing malignancy at the tracheostomy site;

• difficulty in identifying the anatomic landmarks;

• unstable cervical spine fracture;

• international normalized ratio (INR) >2;

• platelet count <50 000 mm3.

Related Conditions & MeSH terms

• Respiratory Depression
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Procedure:
• reformative dilation technique
reformative dilation technique was used when operating tracheostomy

Locations

Country	Name	City	State
China	The Affliated Hospital wiht Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

Natale G, Condino S, Stecco A, Soldani P, Belmonte MM, Gesi M. Is the cervical fascia an anatomical proteus? Surg Radiol Anat. 2015 Nov;37(9):1119-27. doi: 10.1007/s00276-015-1480-1. Epub 2015 May 7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Force(newton)	Force refers to the force needed to dilate the airway and measured by force gauge	Intraoperative (Force was measured the exact moment when investigators insert the'J' guidewire)
Secondary	Time(seconds)	Time refers to the time needed to finish the whole step from tracheal puncture to tracheal tube placement	Time was measured from tracheal puncture to tracheal tube placement, 180 seconds maxime