The Effect of Percutaneous Dilatational Tracheostomy on Intracranial Pressure

NCT06779877 | Active Not Recruiting

• 1 other identifier: AkdenizU.
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Percutaneous dilatational tracheostomy (PDT) is a common bedside alternative to surgical tracheostomy in intensive care unit patients. Intracranial pressure measurement is a vital parameter that should be monitored when performing any procedure including PDT in these patients. During PDT, changes in intracranial pressure may occur depending on the position applied, hypercarbia and hypertension that may develop during the procedure. However, the effect of PDT procedure on intracranial pressure is controversial. It is imperative to ascertain the impact of PDT on intracranial pressure, along with the factors that influence its fluctuations during the procedure. This is of particular significance in order to avert the occurrence of deleterious conditions that may be engendered by elevated intracranial pressure. The aim of current study was to evaluate the effect of PDT procedure on intracranial pressure.

Conditions

Intracranial Pressure Change; Tracheostomy

Keywords

percutaneous dilatational tracheostomy; optic nerve sheath diameter; intracranial pressure

Outcome Measures

Primary Outcomes (1)

• Effect of PDT procedure on intracranial pressure

  The primary outcome of this study was to evaluate the impact of bedside PDT on intracranial pressure through ultrasonography-guided measurement of the optic nerve sheath diameter.

  6 months

Secondary Outcomes (1)

• The effect of presence/absence of intracranial pathology on intracranial pressure change during PDT procedure

  6 months

Study Arms (2)

Patients without intracranial pathology

Patients undergoing PDT who have been shown to have no intracranial pathology by any imaging procedure

Procedure: Percutaneous dilatational tracheostomy; Diagnostic Test: The optic nerve sheath diameter measurement method by ultrasonography

Patients with intracranial pathology

Patients undergoing PDT who have been shown to have intracranial pathology by any imaging procedure

Procedure: Percutaneous dilatational tracheostomy; Diagnostic Test: The optic nerve sheath diameter measurement method by ultrasonography

Interventions

Percutaneous dilatational tracheostomy PROCEDURE

Percutaneous dilatational tracheostomy

Patients with intracranial pathology; Patients without intracranial pathology

The optic nerve sheath diameter measurement method by ultrasonography DIAGNOSTIC_TEST

The optic nerve sheath diameter measurement method by ultrasonography-Determine intracranial pressure.

Patients with intracranial pathology; Patients without intracranial pathology

Eligibility Criteria

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

Study Population

Patients over the age of 18 who were decided to open percutaneous dilatational tracheostomy for various reasons will be included in the study.

You may qualify if:

• Clinical indication for PDT

You may not qualify if:

• Age \<18
• Patients with glaucoma
• Patients with optic nerve damage
• Patients in whom PDT is contraindicated (coagulopathy, infection at the site of intervention, etc.)

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Antalya, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: January 17, 2025
• Study Start: August 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: October 30, 2025
• Last Updated: January 17, 2025

Record last verified: 2025-01

Locations

TU (1)