The Effect of Percutaneous Dilatational Tracheostomy on Intracranial Pressure

The Effect of Percutaneous Dilatational Tracheostomy on Intracranial Pressure: a Prospective Observational Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Tracheostomy; Intracranial Pressure Change
• Intervention / Treatment: Procedure: Percutaneous dilatational tracheostomy; Diagnostic test: The optic nerve sheath diameter measurement method by ultrasonography

Detailed Description

Since the study is a prospective observational study, the investigators will not be the decision-making physicians about the treatments applied to the patients. The optic nerve sheath diameter measurement method by ultrasonography will be used to determine intracranial pressure.Intracranial pressure measurement will be performed in neutral position before PDT, after the patient is positioned for the procedure, immediately after the procedure and immediately after the patient is placed in neutral position. Demographic characteristics, comorbidity status, PDT indication, intensive care unit hospitalisation diagnosis, intracranial pathology data, haemodynamic data, arterial blood gas parameters will be recorded.

• Study Type: Observational
• Enrollment (Estimated): 35

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey
    • Akdeniz University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• Clinical indication for PDT

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients without intracranial pathology; Patients undergoing PDT who have been shown to have no intracranial pathology by any imaging procedure	Procedure: Percutaneous dilatational tracheostomy; Percutaneous dilatational tracheostomy; Diagnostic test: The optic nerve sheath diameter measurement method by ultrasonography; The optic nerve sheath diameter measurement method by ultrasonography-Determine intracranial pressure.
Patients with intracranial pathology; Patients undergoing PDT who have been shown to have intracranial pathology by any imaging procedure	Procedure: Percutaneous dilatational tracheostomy; Percutaneous dilatational tracheostomy; Diagnostic test: The optic nerve sheath diameter measurement method by ultrasonography; The optic nerve sheath diameter measurement method by ultrasonography-Determine intracranial pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of presence/absence of intracranial pathology on intracranial pressure change during PDT procedure	The secondary outcome of this study was to evaluate the effect of the presence/absence of intracranial pathology on intracranial pressure change during bedside PDT procedure by ultrasonography-guided optic nerve sheath diameter measurement.	6 months

Collaborators and Investigators

• Sponsor: Akdeniz University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: January 12, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: intracranial pressure; optic nerve sheath diameter; percutaneous dilatational tracheostomy
• Other Study ID Numbers: AkdenizU.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No