Reformative Versus Single Step Dilation Percutaneous Dilatational Tracheostomy

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

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

Study Overview

• Status: Completed
• Conditions: Respiratory Failure; Respiratory Depression
• Intervention / Treatment: Procedure: reformative dilation technique

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • The Affliated Hospital wiht Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 44 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: sd-PDT group; The investigators applied the traditional standard dilation technique when operating tracheostomy on the standard group.	Procedure: reformative dilation technique; reformative dilation technique was used when operating tracheostomy; Other Names: reformative tracheostomy
EXPERIMENTAL: re-PDT group; The investigators applied the reformative dilation technique when operating tracheostomy on the re-PDT group.	Procedure: reformative dilation technique; reformative dilation technique was used when operating tracheostomy; Other Names: reformative tracheostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time(seconds)	Time refers to the time needed to finish the whole step from tracheal puncture to tracheal tube placement	Time was measured from tracheal puncture to tracheal tube placement, 180 seconds maxime

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Investigators: Study Chair: Jinhai Li, The First Affliated Hospital with Nanjing Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2012
• Primary Completion (ACTUAL): December 30, 2016
• Study Completion (ACTUAL): February 15, 2017

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (ACTUAL): May 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 2017
• Last Update Submitted That Met QC Criteria: May 4, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: tracheostomy，fascia，force gauge
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 2017-SR-078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No