The Effect of Percutaneous Dilatational Tracheostomy on Intracranial Pressure

NCT ID: NCT06779877

Last Updated: 2025-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-10-30

Brief Summary

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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

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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.

Conditions

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Intracranial Pressure Change Tracheostomy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients without intracranial pathology

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

Percutaneous dilatational tracheostomy

Intervention Type PROCEDURE

Percutaneous dilatational tracheostomy

The optic nerve sheath diameter measurement method by ultrasonography

Intervention Type DIAGNOSTIC_TEST

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

Percutaneous dilatational tracheostomy

Intervention Type PROCEDURE

Percutaneous dilatational tracheostomy

The optic nerve sheath diameter measurement method by ultrasonography

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Percutaneous dilatational tracheostomy

Percutaneous dilatational tracheostomy

Intervention Type PROCEDURE

The optic nerve sheath diameter measurement method by ultrasonography

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Melike Cengiz

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Akdeniz University

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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AkdenizU.

Identifier Type: -

Identifier Source: org_study_id

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