Percutaneous Tracheostomy

NCT05343442 | Completed Phase 4 DMC

• 1 other identifier: 0305355
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 1

Brief Summary

Description of a technical modification of percutaneous tracheostomy that involves a safety method for confirming the intratracheal location of the needle at the time of puncture, with preventing serious complications such as false passage or damage to the posterior tracheal wall, without coadjuvant technique

Conditions

Tracheostomy

Keywords

Intensive care unit; Trachea; Tracheostomy; Tracheostomy cannula; Critically ill

Outcome Measures

Primary Outcomes (1)

• Percutaneous tracheostomy procedure

  Novel technique time: which is the time from tracheal tube puncture till J-guidewire insertion into the trachea

  7 days

Secondary Outcomes (1)

• Complications of the procedure

  7 days

Study Arms (1)

Patients assigned to percutaneous tracheostomy

EXPERIMENTAL

Guidewire dilating forceps (Grigges') technique was the method which has been applied during our work. Proper positioning: patient's neck was extended as much as possible by placing a rolled towel between the shoulder blades, the patient's neck and the bed were maintained in neutral position. The operative site was sterilized before draping with 10% povidone iodine solution. Lidocaine 2% was used as local anesthetic prior to beginning the intervention. Transverse (1 cm) skin incision was made midway between the cricoid cartilage and the suprasternal notch, i.e., opposite the 2nd - 3rd or 3rd - 4th tracheal rings. Blunt dissection of subcutaneous fat and pre-tracheal tissue with mosquito clamp in a vertical direction was done till the tracheal rings were palpable.

Procedure: Percutaneous tracheostomy

Interventions

Percutaneous tracheostomy PROCEDURE

Guidewire dilating forceps (Grigges') technique was the method which has been applied during our work. Proper positioning: patient's neck was extended as much as possible by placing a rolled towel between the shoulder blades, the patient's neck and the bed were maintained in neutral position. The operative site was sterilized before draping with 10% povidone iodine solution. Lidocaine 2% was used as local anesthetic prior to beginning the intervention. Transverse (1 cm) skin incision was made midway between the cricoid cartilage and the suprasternal notch, i.e., opposite the 2nd - 3rd or 3rd - 4th tracheal rings. Blunt dissection of subcutaneous fat and pre-tracheal tissue with mosquito clamp in a vertical direction was done till the tracheal rings were palpable.

Patients assigned to percutaneous tracheostomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical indication for tracheostomy

You may not qualify if:

• Age \<18, patients with severe coagulopathy, and unsuitable anatomy (e.g., previous cervical surgery, cervical trauma, or tumors).

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria Faculty of Medicine

Alexandria, 21651, Egypt

Location

Related Publications (1)

• Ciaglia P, Firsching R, Syniec C. Elective percutaneous dilatational tracheostomy. A new simple bedside procedure; preliminary report. Chest. 1985 Jun;87(6):715-9. doi: 10.1378/chest.87.6.715.

  PMID: 3996056 RESULT

Related Links

• Main link

MeSH Terms

Conditions

Tracheal Diseases; Critical Illness

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Observational study

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 25, 2022
• Study Start: December 19, 2021
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: April 25, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available after statistical analysis for one year

Locations

EG (1)