Classical laryngeal mask, Proseal laryngeal mask or endotracheal tube for percutaneous dalatational tracheostomy: A comparison of quality of ventilation, view and complications.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00008007

Enrollment

104

Registered

2015-04-16

Start date

2010-01-11

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

increase of paCO2 during percutaneous dilatational trachostomy G93.6

Interventions

Group 1: endotracheal tube for bronchoscopy and ventilation during tracheostomy. Primary endpoint of the investigation: paCO2 Group 2: laryngeal mask airway Pro Seal for bronchoscopy and ventilation d

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - indication for tracheostomy - >2 failed extubations - prolonged ventilation > 1week - persistant impaired ability to swallow - persistant missing cough reflex

Exclusion criteria

Exclusion criteria: - exsessive struma - previous complicated endotracheal intubation (Cormack/Lehane 4) - missing consent - < 18 years old - pregnancy

Design outcomes

Primary

Measure	Time frame
To capture paCO2 blodd gas analysises were realised by reference to a standarized protocoll: - before FiO2 1,0 (before starting to implement measures) - 10 minutes after preoxygenation with FiO2 1,0 - before puncture the trachea 1 minute postoperative documented were pH, paCO2, PaO2 and sHCO3-	—

Secondary

Measure	Time frame
Following haemodynamic and respiratory parameters were documented by a stadarized protocoll before FiO2 1,0, 10 minutes after FiO2 1,0, after optimized parameters of ventilation, before puncture of the trachea and 1 minute postoperativ: -Heart rate - MAP - SaO2 - tidal volume - respiratory minute volume - breathing frequency - end-tidal CO2 - PEEP The assessment of the single steps of the procedure were documented by a standarized scoring (1-4). scoring during the steps A-F: A: Insertion of laryngeal mask, returning endotrachealtube B: Insertion of the bronchoscope C: identification of tracheal strutures D: controll of the puncture E: controll of the dilatation F: View of the trachea	—

Measure

Time frame

Following haemodynamic and respiratory parameters were documented by a stadarized protocoll before FiO2 1,0, 10 minutes after FiO2 1,0, after optimized parameters of ventilation, before puncture of the trachea and 1 minute postoperativ: -Heart rate - MAP - SaO2 - tidal volume - respiratory minute volume - breathing frequency - end-tidal CO2 - PEEP The assessment of the single steps of the procedure were documented by a standarized scoring (1-4). scoring during the steps A-F: A: Insertion of laryngeal mask, returning endotrachealtube B: Insertion of the bronchoscope C: identification of tracheal strutures D: controll of the puncture E: controll of the dilatation F: View of the trachea

—

Countries

Germany

Contacts

Public ContactUlf Linstedt

Diako Flensburg

linstedtul@diako.de0461 812 1601

Outcome results

None listed

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