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Reformative Versus Single Step Dilation Percutaneous Dilatational Tracheostomy

Primary Purpose

Respiratory Failure, Respiratory Depression

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
reformative dilation technique
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring tracheostomy，fascia，force gauge

Eligibility Criteria

44 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The Affliated Hospital wiht Nanjing Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

sd-PDT group

re-PDT group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Force(newton)
Force refers to the force needed to dilate the airway and measured by force gauge

Secondary Outcome Measures

Time(seconds)
Time refers to the time needed to finish the whole step from tracheal puncture to tracheal tube placement

Full Information

First Posted
April 20, 2017
Last Updated
May 4, 2017
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03141294
Brief Title
Reformative Versus Single Step Dilation Percutaneous Dilatational Tracheostomy
Official Title
Reformative Versus Single Step Dilation Percutaneous Dilatational Tracheostomy: a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2012 (Actual)
Primary Completion Date
December 30, 2016 (Actual)
Study Completion Date
February 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Respiratory Depression
Keywords
tracheostomy，fascia，force gauge

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sd-PDT group
Arm Type
Placebo Comparator
Arm Description
The investigators applied the traditional standard dilation technique when operating tracheostomy on the standard group.
Arm Title
re-PDT group
Arm Type
Experimental
Arm Description
The investigators applied the reformative dilation technique when operating tracheostomy on the re-PDT group.
Intervention Type
Procedure
Intervention Name(s)
reformative dilation technique
Other Intervention Name(s)
reformative tracheostomy
Intervention Description
reformative dilation technique was used when operating tracheostomy
Primary Outcome Measure Information:
Title
Force(newton)
Description
Force refers to the force needed to dilate the airway and measured by force gauge
Time Frame
Intraoperative (Force was measured the exact moment when investigators insert the'J' guidewire)
Secondary Outcome Measure Information:
Title
Time(seconds)
Description
Time refers to the time needed to finish the whole step from tracheal puncture to tracheal tube placement
Time Frame
Time was measured from tracheal puncture to tracheal tube placement, 180 seconds maxime

10. Eligibility

Sex
All
Minimum Age & Unit of Time
44 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinhai Li
Organizational Affiliation
The first Affliated Hospital with Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The Affliated Hospital wiht Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
25946970
Citation
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.
Results Reference
result

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Reformative Versus Single Step Dilation Percutaneous Dilatational Tracheostomy

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