Reformative Versus Single Step Dilation Percutaneous Dilatational Tracheostomy

Nanjing Medical University

Status: Completed

Conditions: Respiratory Failure; Respiratory Depression

Treatments: Procedure: reformative dilation technique

Study type: Interventional

Funder types: Other

Identifiers

NCT03141294

2017-SR-078

Details and patient eligibility

About

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

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 44 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups, including a placebo group

sd-PDT group

Placebo Comparator group

Description:

The investigators applied the traditional standard dilation technique when operating tracheostomy on the standard group.

Treatment:

Procedure: reformative dilation technique

re-PDT group

Experimental group

Description:

The investigators applied the reformative dilation technique when operating tracheostomy on the re-PDT group.

Treatment:

Procedure: reformative dilation technique