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Reformative Versus Single Step Dilation Percutaneous Dilatational Tracheostomy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03141294
Enrollment
46
Registered
2017-05-05
Start date
2012-07-01
Completion date
2017-02-15
Last updated
2017-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Depression, Respiratory Failure

Keywords

tracheostomy,fascia,force gauge

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.

Interventions

PROCEDUREreformative dilation technique

reformative dilation technique was used when operating tracheostomy

Sponsors

The First Affiliated Hospital with Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
44 Years to 89 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Time(seconds)Time was measured from tracheal puncture to tracheal tube placement, 180 seconds maximeTime refers to the time needed to finish the whole step from tracheal puncture to tracheal tube placement

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026