Trial comparing safety and efficacy of Proseal LMA use for bronchoscopy during Percutaneous tracheostomy

Assessment of Efficacy and Safety of Proseal LMA Versus Endotracheal Tube for Airway Management During Percutaneous Dilational Tracheostomy in Critically Ill Patients A Randomized Control Trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/081690

Enrollment

Registered

2025-03-05

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: SGA for PDT: Bronchoscopic guidance and airway control provided using a 2nd generation SGA during performance of PDT Control Intervention1: ETT for PDT: Bronchoscopic guidance and airwa

Eligibility

Inclusion criteria

Inclusion criteria: Critically ill patients planned to undergo PDT for their current illness in accordance to institutional protocols

Exclusion criteria

Exclusion criteria: Refusal of consent, Uncorrected coagulopathy, Contraindications for PDT, Patients unlikely to survive beyond 48 hours, Contraindications for SGA use, Pregnant patients

Design outcomes

Primary

Measure	Time frame
To compare the mean time taken in performing the percutaneous tracheostomy (skin incision to placement of tracheostomy tube) when ProSeal LMA vs ETT is used for maintenance of airway during bronchoscopy guided PDT in critically ill patients.Timepoint: At the end of procedure	—

Secondary

Measure	Time frame
Time taken from insertion of bronchoscope to obtaining a procedure ready viewTimepoint: At the end of procedure;Time taken from insertion of bronchoscope to connection of ventilation to tracheostomy tubeTimepoint: At the end of procedure;Qualitative assessment of structures visualizedTimepoint: At the end of procedure;Maximum reduction in expired tidal volume from set value (leak)Timepoint: At the end of procedure;Increase in peak airway pressures (max) after inserting bronchoscopeTimepoint: At the end of procedure;Incidence of Ventilator Associated Events (VAEs)Timepoint: till 28 days after procedure	—

Measure

Time frame

Time taken from insertion of bronchoscope to obtaining a procedure ready viewTimepoint: At the end of procedure;Time taken from insertion of bronchoscope to connection of ventilation to tracheostomy tubeTimepoint: At the end of procedure;Qualitative assessment of structures visualizedTimepoint: At the end of procedure;Maximum reduction in expired tidal volume from set value (leak)Timepoint: At the end of procedure;Increase in peak airway pressures (max) after inserting bronchoscopeTimepoint: At the end of procedure;Incidence of Ventilator Associated Events (VAEs)Timepoint: till 28 days after procedure

—

Countries

India

Contacts

Public ContactMudit Joshi

ABVIMS & Dr RML Hospital

rsindhoo@yahoo.in9001004587

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026