Reformative Versus Single Step Dilation Percutaneous Dilatational Tracheostomy

Not Applicable

Completed

• Conditions: Respiratory Depression; Respiratory Failure
• Interventions: Procedure: reformative dilation technique

• Registration Number: NCT03141294
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2012-07-01
• Primary Completion: 2016-12-30
• Study Completion: 2017-02-15
• Study First Submitted: 2017-04-20
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-04
• Last Update Submitted: 2017-05-04
• Study First Posted: 2017-05-05
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sd-PDT group	reformative dilation technique	The investigators applied the traditional standard dilation technique when operating tracheostomy on the standard group.
re-PDT group	reformative dilation technique	The investigators applied the reformative dilation technique when operating tracheostomy on the re-PDT group.

Primary Outcome Measures

Name	Time	Method
Force(newton)	Intraoperative (Force was measured the exact moment when investigators insert the'J' guidewire)	Force refers to the force needed to dilate the airway and measured by force gauge

Secondary Outcome Measures

Name	Time	Method
Time(seconds)	Time was measured from tracheal puncture to tracheal tube placement, 180 seconds maxime	Time refers to the time needed to finish the whole step from tracheal puncture to tracheal tube placement

Trial Locations

Locations (1)

The Affliated Hospital wiht Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China