Intracranial Pressure ChangeNCT06779877
The Effect of Percutaneous Dilatational Tracheostomy on Intracranial Pressure
An observational study of Intracranial Pressure Change and Tracheostomy, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Pressure Change, Tracheostomy
- What is being tested?
- Percutaneous dilatational tracheostomy and The optic nerve sheath diameter measurement method by ultrasonography
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 30 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Clinical indication for PDT
Who cannot join
- Age <18
- Patients with glaucoma
- Patients with optic nerve damage
- Patients in whom PDT is contraindicated (coagulopathy, infection at the site of intervention, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Percutaneous Dilatational Tracheostomy on Intracranial Pressure: a Prospective Observational Study
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.
Read the 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.
- Conditions
- Intracranial Pressure Change, Tracheostomy
- Being tested
- Percutaneous dilatational tracheostomy, The optic nerve sheath diameter measurement method by ultrasonography
- Keywords
- percutaneous dilatational tracheostomy, optic nerve sheath diameter, intracranial pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous dilatational tracheostomyProcedure or surgery
Percutaneous dilatational tracheostomy
The optic nerve sheath diameter measurement method by ultrasonographyDiagnostic test
The optic nerve sheath diameter measurement method by ultrasonography-Determine intracranial pressure.
| Study group | Role | What they receive |
|---|---|---|
| Patients without intracranial pathology | Patients undergoing PDT who have been shown to have no intracranial pathology by any imaging procedure Receives: Procedure: Percutaneous dilatational tracheostomy; Diagnostic Test: The optic nerve sheath diameter measurement method by ultrasonography | |
| Patients with intracranial pathology | Patients undergoing PDT who have been shown to have intracranial pathology by any imaging procedure Receives: Procedure: Percutaneous dilatational tracheostomy; Diagnostic Test: The optic nerve sheath diameter measurement method by ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of PDT procedure on intracranial pressure
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.
Measured: 6 months
Secondary outcomes (1)
The effect of presence/absence of intracranial pathology on intracranial pressure change during PDT procedure
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start1 Aug 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Pressure ChangeStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melike Cengiz, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779877
- Sponsor's protocol ID
- AkdenizU.
- Status last verified
- Jan 2025
- First submitted
- 12 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Percutaneous Dilatational Tracheostomy on Intracranial Pressure: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06779877
- Acronym / sponsor ID
- AkdenizU.
- Conditions
- Intracranial Pressure Change, Tracheostomy
- Keywords
- percutaneous dilatational tracheostomy, optic nerve sheath diameter, intracranial pressure
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without intracranial pathology | – | Procedure: Percutaneous dilatational tracheostomy, Diagnostic Test: The optic nerve sheath diameter measurement method by ultrasonographyPatients undergoing PDT who have been shown to have no intracranial pathology by any imaging procedure |
| Patients with intracranial pathology | – | Procedure: Percutaneous dilatational tracheostomy, Diagnostic Test: The optic nerve sheath diameter measurement method by ultrasonographyPatients undergoing PDT who have been shown to have intracranial pathology by any imaging procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Clinical indication for PDT
Key exclusion criteria (4 listed)
- Age <18
- Patients with glaucoma
- Patients with optic nerve damage
- Patients in whom PDT is contraindicated (coagulopathy, infection at the site of intervention, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous dilatational tracheostomyPercutaneous dilatational tracheostomy | Procedure or surgery | Patients with intracranial pathology, Patients without intracranial pathology |
| The optic nerve sheath diameter measurement method by ultrasonographyThe optic nerve sheath diameter measurement method by ultrasonography-Determine intracranial pressure. | Diagnostic test | Patients with intracranial pathology, Patients without intracranial pathology |
Primary outcome
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.
1 secondary outcome
The effect of presence/absence of intracranial pathology on intracranial pressure change during PDT procedure
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Pressure Change and Tracheostomy, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of PDT procedure on intracranial pressure (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.