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Comparison of two airway devices to aid breathing during percutaneous tracheostomy

A prospective randomised controlled trial of airway management in patients undergoing percutaneous tracheostomy and its effect on hypercarbia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN23203142
Enrollment
50
Registered
2009-11-17
Start date
2009-12-01
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Percutaneous tracheostomy Surgery Percutaneous tracheostomy

Interventions

LMA Supreme™ versus cuffed oral endotracheal tube. Duration of intervention is variable but no more than 60 minutes. There is no follow up beyond the procedure itself.

Sponsors

NHS Lothian (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged over 18 years, either sex 2. Require a percutaneous tracheostomy as part of ongoing intensive care therapy

Exclusion criteria

Exclusion criteria: 1. Aged less than 18 years 2. Patient or relative/welfare guardian refusal 3. Treating clinician refusal

Design outcomes

Primary

MeasureTime frame
Change in partial pressure of carbon dioxide in arterial blood (PaCO2) levels between start of percutaneous tracheostomy procedure and completion of tracheostomy procedure.

Secondary

MeasureTime frame
Measured during the procedure and immediately on completion of the procedure: 1. Combined complications (desaturation less than 92% during procedure, repositioning of airway device during procedure, loss of airway during procedure) 2. How many people required to help with airway maintenance 3. View on bronchoscopy of procedure 4. Time to airway ready 5. Total time from incision to tracheostomy placement

Countries

United Kingdom

Outcome results

None listed

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