Clinical trial NCT06779877: The Effect of Percutaneous Dilatational Tracheostomy on Intracranial Pressure
Official title: The Effect of Percutaneous Dilatational Tracheostomy on Intracranial Pressure: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Intracranial Pressure Change
Tracheostomy
Keywords: percutaneous dilatational tracheostomy
optic nerve sheath diameter
intracranial pressure
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Effect of PDT procedure on intracranial pressure
timeFrame: 6 months
Secondary outcomes:
measure: The effect of presence/absence of intracranial pathology on intracranial pressure change during PDT procedure
timeFrame: 6 months
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
References: