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IRCT20260803070511N1 IRCT 2026-08-09 Deputy of Research and Technology, Mashhad University of Medical Sciences Comparison of the Effectiveness of Ultrasound-Guided Versus Anatomical Landmark-Guided Percutaneous Dilatational Tracheostomy CEULPDT Comparison of the Effectiveness of Ultrasound-Guided Versus Anatomical Landmark-Guided Percutaneous Dilatational Tracheostomy in Intensive Care Unit Patients 2027-09-05 anticipated 70 Pending https://irct.ir/trial/92204 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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, 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. 3 Percutaneous dilatational tracheostomy Ultrasound-guided tracheostomy Anatomical landmark-based tracheostomy Prolonged mechanical ventilationTracheostomy-related complications. Intervention 1: 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. Intervention 2: Control group: Control group: Patients underwent conventional landmark-guided PDT based on palpation of anatomical landmarks without ultrasound assistance. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information related to the primary outcome or similar data, can be shared. When: from 2026 To whom: Only for researchers affiliated with academic institutions. Conditions: Only for researchers affiliated with academic institutions. Where to obtain: Jamshidi_saeed@yahoo.com How to obtain: Via the provided email address. Comments: None
public DR Saeed Jamshidi
no 11 honarestan 25
Mashhad Iran (Islamic Republic of) 9178746936 +98 51 3868 2039 Jamshidi_saeed@yahoo.com Mashhad University of Medical Sciences scientific Dr Saeed Jamshidi
no 11 honarestan 25
Mashhad Iran (Islamic Republic of) 9178746936 +98 51 3868 2039 jamshidi_saeed@yahoo.com Mashhad University of Medical Sciences Iran (Islamic Republic of) • 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. 18 years no limit Both 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. Z93.0 J95. Z93.0 — Tracheostomy status Z99.1 — Dependence on respirator J96.0 — Acute respiratory failure J95.0 — Tracheostomy complications Treatment - Other Treatment - Other 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. Control group: Control group: Patients underwent conventional landmark-guided PDT based on palpation of anatomical landmarks without ultrasound assistance. 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. 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. Deputy of Research and Technology, Mashhad University of Medical Sciences Approved 2026-08-03 Ethics committee of Mashhad University of Medical Sciences No 11 Honarestan 25 Mashhad Razavi Khorasan Iran (Islamic Republic of)