Comparison of the Effectiveness of Ultrasound-Guided Versus Anatomical Landmark-Guided Percutaneous Dilatational Tracheostomy in Intensive Care Unit Patients
compare the effectiveness and safety of ultrasound-guided percutaneous dilatational tracheostomy with the conventional landmark-based technique in ICU patients.
Design
This study was a randomized, open-label comparative study conducted in 70 ICU patients. The participants were allocated into two equal groups of 35 patients each: an ultrasound-guided percutaneous dilatational tracheostomy group and a conventional landmark-based tracheostomy group.
Settings and conduct
This study was conducted in the intensive care units of Qaem and Emam Reza educational, research, and treatment hospitals affiliated with Mashhad University of Medical Sciences. Eligible patients underwent percutaneous dilatational tracheostomy at the bedside under continuous monitoring of ECG, oxygen saturation, and blood pressure after informed consent was obtained.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
• Critically ill patients requiring tracheostomy due to prolonged mechanical ventilation, airway obstruction, or other medical indications.
• Age ≥18 years.
• Patients with stable vital signs and acceptable laboratory values (e.g., normal platelet count, no active infection at the insertion site).
• Patients who are expected to remain in the hospital for a minimum of 48 hours after the procedure.
Exclusion Criteria:
• Patients with coagulopathies (e.g., anticoagulation therapy that cannot be stopped before the procedure).
• Patients with anatomical deformities of the neck (e.g., extensive scarring from prior surgeries, tumors, or trauma) that preclude either technique.
• Pregnant women or patients who are unable to provide informed consent.
Intervention groups
The intervention group consisted of patients who underwent ultrasound-guided percutaneous dilatational tracheostomy.
Main outcome variables
Overall procedural success
General information
Reason for update
Acronym
CEULPDT
IRCT registration information
IRCT registration number:IRCT20260803070511N1
Registration date:2026-08-09, 1405/05/18
Registration timing:prospective
Last update:2026-08-09, 1405/05/18
Update count:0
Registration date
2026-08-09, 1405/05/18
Registrant information
Name
Saeed Jamshidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 315 5196
Email address
jamshidi_saeed@yahoo.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2027-09-05, 1406/06/14
Expected recruitment end date
2028-10-06, 1407/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Ultrasound-Guided Versus Anatomical Landmark-Guided Percutaneous Dilatational Tracheostomy in Intensive Care Unit Patients
Public title
Comparison of the Effectiveness of Ultrasound-Guided Versus Anatomical Landmark-Guided Percutaneous Dilatational Tracheostomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• Critically ill patients requiring tracheostomy due to prolonged mechanical ventilation, airway obstruction, or other medical indications.
• Age ≥18 years.
• Patients with stable vital signs and acceptable laboratory values (e.g., normal platelet count, no active infection at the insertion site).
• Patients who are expected to remain in the hospital for a minimum of 48 hours after the procedure.
Exclusion criteria:
Patients with coagulopathies (e.g., anticoagulation therapy that cannot be stopped before the procedure).•
Patients with anatomical deformities of the neck (e.g., extensive scarring from prior surgeries, tumors, or trauma) that preclude either technique.•
Pregnant women or patients who are unable to provide informed consent.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
After assessment of the eligibility criteria and obtaining informed consent, eligible patients were randomly assigned in a 1:1 ratio to one of the two study groups: the intervention group, in which percutaneous dilatational tracheostomy was performed under ultrasound guidance, and the control group, in which the procedure was performed using the standard anatomical landmark-based technique.
The unit of randomization was the individual patient, and no cluster randomization was applied. To maintain balance between the two groups, block randomization was used. The random allocation sequence was generated before patient enrollment using statistical software. No stratified randomization was performed; therefore, patients were not stratified according to variables such as age, sex, or disease severity.
To ensure allocation concealment, the randomization sequence was placed in sequentially numbered, opaque, sealed envelopes. After confirming patient eligibility and obtaining informed consent, the next envelope in sequence was opened, and the assigned study group was revealed. This process prevented prediction of group assignment before final enrollment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The main objective of this study was to compare the effectiveness and safety of ultrasound-guided percutaneous dilatational tracheostomy with the conventional landmark-based technique in ICU patients.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Z93.0 — Tracheostomy status Z99.1 — Dependence on respirator J96.0 — Acute respiratory failure J95.0 — Tracheostomy complications
Primary outcomes
1
Description
First Sucess rate
Timepoint
The procedure duration was measured in minutes, from the initiation of needle puncture until the appearance of the ventilator waveform (i.e., confirmation of effective ventilation
Method of measurement
Overall success was defined as successful completion of the tracheostomy procedure with correct placement of the tracheostomy tube in the appropriate position.
Secondary outcomes
1
Description
Procedure time
Timepoint
The procedure duration was measured in minutes, from the initiation of needle puncture until the appearance of the ventilator waveform (i.e., confirmation of effective ventilation).
Method of measurement
confirmation of effective ventilation
Intervention groups
1
Description
Intervention group: Patients underwent ultrasound-guided PDT, in which bedside ultrasound was used to identify tracheal rings, determine the optimal puncture site, measure skin-to-trachea distance, and avoid vascular or thyroid injury. Needle puncture was performed under static or real-time ultrasound guidance, followed by guidewire insertion.
Category
Treatment - Other
2
Description
Control group: Control group: Patients underwent conventional landmark-guided PDT based on palpation of anatomical landmarks without ultrasound assistance.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital Mashhad
Full name of responsible person
Dr Saeed Jamshidi
Street address
Ahmad Abad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
111111111
Phone
+98 51 3840 0000
Fax
+98 51 3840 0000
Email
Jamshidi_saeed@yahoo.com
Web page address
https://www.ghaem-hospital.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology, Mashhad University of Medical Sciences
Full name of responsible person
Dr Zahra Meshkat
Street address
Azadi Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
1111111111
Phone
+98 51 3840 0000
Fax
+98 51 3840 0000
Email
Jamshidi_saeed@yahoo.com
Web page address
https://www.ghaem-hospital.ir/
Grant name
N/A
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
DR Saeed Jamshidi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
no 11 honarestan 25
City
Mashhad
Province
Razavi Khorasan
Postal code
9178746936
Phone
+98 51 3868 2039
Fax
+98 51 3868 2039
Email
Jamshidi_saeed@yahoo.com
Web page address
https://quaem.mums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Saeed Jamshidi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
no 11 honarestan 25
City
Mashhad
Province
Razavi Khorasan
Postal code
9178746936
Phone
+98 51 3868 2039
Fax
+98 51 3868 2039
Email
jamshidi_saeed@yahoo.com
Web page address
https://quaem.mums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Saeed Jamshidi
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
no 11 honarestan 25
City
mashhad
Province
Razavi Khorasan
Postal code
9178746936
Phone
+98 51 3868 2039
Fax
+98 51 3868 2039
Email
jamshidi_saeed@yahoo.com
Web page address
https://quaem.mums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data, such as information related to the primary outcome or similar data, can be shared.
When the data will become available and for how long
from 2026
To whom data/document is available
Only for researchers affiliated with academic institutions.
Under which criteria data/document could be used
Only for researchers affiliated with academic institutions.
From where data/document is obtainable
Jamshidi_saeed@yahoo.com
What processes are involved for a request to access data/document