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A study to compare outcomes of bedside tracheostomy with and without ultrasound guidance in adult ICU patients

A randomized controlled study comparing real-time ultrasound guidance versus standard practice for percutaneous dilatational tracheostomy in adult intensive care patients - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/103849
Enrollment
60
Registered
2026-02-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J960- Acute respiratory failure Health Condition 2: G931- Anoxic brain damage, not elsewhereclassified Health Condition 3: I639- Cerebral infarction, unspecified Health Condition 4: J961- Chronic respiratory failure Health Condition 5: Z991- Dependence on respirator Health Condition 6: G939- Disorder of brain, unspecified Health Condition 7: I619- Nontraumatic intracerebral hemorrhage, unspecified Health Condition 8: R403- Persistent vegetative state Health Condition 9: J969-

Interventions

Intervention1: Real-time ultrasound guidance arm: Pre-procedural mapping as in standard practice arm. Real-time ultrasound guidance- Ultrasound probe maintained in transverse or longitudinal /oblique

Sponsors

Meitra Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age more than or equal to 18 years 2.Adult patients admitted in ICU and requiring elective percutaneous tracheostomy (anticipated prolonged mechanical ventilation, airway protection, or weaning facilitation) 3. Feasible neck anatomy for percutaneous tracheostomy as per attending intensivist. 4. Informed consent from patient or legally authorized representative

Exclusion criteria

Exclusion criteria: 1. Need for emergency surgical airway. 2. Unfavorable anatomy requiring surgical tracheostomy. 3. Previous tracheostomy or major neck surgery with distorted anatomy (eg., laryngectomy, radical neck dissection). 4. Local neck infection at planned tracheostomy site. 5. Uncorrected coagulopathy beyond institutional thresholds (e.g., platelets less than 50,000/ L, INR more than 1.5) not correctable prior to procedure. 6. Severe cervical spine instability or immobilization where ultrasound access is severely limited

Design outcomes

Primary

MeasureTime frame
Incidence of tracheal cartilage injury, defined as any of the following observed on immediate post-procedural bronchoscopy : Cartilage fracture (visible step, discontinuity, or mobile fragment). Cartilage dislocation or subluxation. Cartilage exposure with mucosal tear overlying tracheal rings. [Bronchoscopic videos will be assessed by at least two experienced bronchoscopists blinded to group allocation. Disagreements will be resolved by consensus or a third reviewer.]Timepoint: Primary outcome assessed post-procedure using bronchoscopy video by blind assessors within 1 week

Secondary

MeasureTime frame
Vasular Injury or bleedingTimepoint: During procedure;Posterior tracheal wall contact or injuryTimepoint: During procedure;PneumothoraxTimepoint: within 24 hours of procedure;Subcutaneous emphysemaTimepoint: within 24 hours of procedure;Failed procedure or conversion to surgical tracheostomyTimepoint: During procedure;Procedure time in minutesTimepoint: During procedure;Number of puncture attemptsTimepoint: During procedure;off Midline or suboptimal puncture sites- as per ultrasound or bronchoscopy assessmentTimepoint: During procedure

Countries

India

Contacts

Public ContactShahid Pullat

Meitra Hospital, Calicut

drpshahid7@gmail.com9656567111

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026