NCT03141294

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

4.5 years

First QC Date

April 20, 2017

Last Update Submit

May 4, 2017

Conditions

Respiratory FailureRespiratory Depression

Keywords

tracheostomy，fascia，force gauge

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Time(seconds)

    Time was measured from tracheal puncture to tracheal tube placement, 180 seconds maxime

Study Arms (2)

sd-PDT group

PLACEBO COMPARATOR

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

Procedure: reformative dilation technique

re-PDT group

EXPERIMENTAL

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

Procedure: reformative dilation technique

Interventions

reformative dilation techniquePROCEDURE

reformative dilation technique was used when operating tracheostomy

Also known as: reformative tracheostomy
re-PDT groupsd-PDT group

Eligibility Criteria

Age44 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥18 years;
  • requirement for long-term mechanical ventilation;
  • failure of weaning from mechanical ventilation.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affliated Hospital wiht Nanjing Medical University

Nanjing, Jiangsu, China

Location

Related 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.

    PMID: 25946970RESULT

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Jinhai Li

    The first Affliated Hospital with Nanjing Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
attending physician

Study Record Dates

First Submitted

April 20, 2017

First Posted

May 5, 2017

Study Start

July 1, 2012

Primary Completion

December 30, 2016

Study Completion

February 15, 2017

Last Updated

May 5, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will share

Locations

CN(1)