The Effect of Percutaneous Dilatational Tracheostomy on Intracranial Pressure

Active, not recruiting

• Conditions: Intracranial Pressure Change; Tracheostomy

• Registration Number: NCT06779877
• Lead Sponsor: Akdeniz University

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.

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 Timeline

• Study Start: 2024-08-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-12
• Study First Submitted QC: 2025-01-15
• Last Update Submitted: 2025-01-15
• Study First Posted: 2025-01-17
• Last Update Posted: 2025-01-17
• Primary Completion: 2025-06-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of PDT procedure on intracranial pressure	6 months	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.

Secondary Outcome Measures

Name	Time	Method
The effect of presence/absence of intracranial pathology on intracranial pressure change during PDT procedure	6 months	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.

Trial Locations

Locations (1)

Akdeniz University; 🇹🇷 Antalya, Turkey