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NCT Number: NCT06779877

The Effect of Percutaneous Dilatational Tracheostomy on Intracranial Pressure

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.

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Key information

Conditions

Intracranial Pressure Change Tracheostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Akdeniz University

Antalya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Percutaneous dilatational tracheostomy

Procedure

Percutaneous dilatational tracheostomy

The optic nerve sheath diameter measurement method by ultrasonography

Diagnostic Test

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

Primary outcomes

  1. Effect of PDT procedure on intracranial pressure

    Time frame: 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 outcomes

  1. The effect of presence/absence of intracranial pathology on intracranial pressure change during PDT procedure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2025
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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