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To identify if a new combination of interventions to perform tracheostomy (access to windpipe for ventilation) can reduce complications in ICU

Efficacy of a novel bundle of care to reduce complication following percutaneous dilatational tracheostomy in critically ill patients: randomized controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/034494
Enrollment
110
Registered
2021-06-30
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: J22- Unspecified acute lower respiratory infection

Interventions

Intervention1: Novel bundle of care for performing percutaneous dilatational tracheostomy: The following bundle of intervention will be followed. The specific checklist will be read out and strictly a
volume 3-5 ml e) Pre-puncture dissection - To be done before needle puncture (approximately 1-1.5cm incision and blunt dissection of subcutaneous tissue and strap muscles) 3. Procedure phase â?? a) B

Sponsors

All India Institute of Medical Sciences New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All adult patients undergoing PDT in ICU will be recruited after informed written consent from the patients or legally acceptable representatives (LAR).

Exclusion criteria

Exclusion criteria: Exclusion criteria will be a) patient refusal, b) emergency tracheostomy and c) morbid obesity (BMI > 35Kg/m2).

Design outcomes

Primary

MeasureTime frame
Composite complication rate in both the groupsTimepoint: Composite complication rate in both the groups at 28 days

Secondary

MeasureTime frame
a) Individual complications rate (airway trauma, bleeding, wound infection) b) Duration of procedure c) Days to free from ventilator after PDT d) Days to decanulation e) ICU length of stay f) In hospital mortality Timepoint: Till hospital discharge or death. Days to decannulation will be assessed by telephonic interview after three months

Countries

India

Contacts

Public ContactDivya Hirolli

AIIMS New Delhi

dalimkumar.ab8@gmail.com

Outcome results

None listed

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