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The Effect of Percutaneous Dilatational Tracheostomy on Intracranial Pressure

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06779877
Enrollment
35
Registered
2025-01-17
Start date
2024-08-01
Completion date
2025-10-30
Last updated
2025-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Pressure Change, Tracheostomy

Keywords

percutaneous dilatational tracheostomy, optic nerve sheath diameter, intracranial pressure

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.

Interventions

Percutaneous dilatational tracheostomy

DIAGNOSTIC_TESTThe optic nerve sheath diameter measurement method by ultrasonography

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

Sponsors

Akdeniz University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
Effect of PDT procedure on intracranial pressure6 monthsThe 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

MeasureTime frameDescription
The effect of presence/absence of intracranial pathology on intracranial pressure change during PDT procedure6 monthsThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026