Comparison of oropharyngeal leakage pressures between Ambu® AuraGain™ and Flexicare® LarySeal Pro™ laryngeal masks. A randomized, prospective, single-blinded and monocentric study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00033687

Enrollment

140

Registered

2024-02-26

Start date

2024-04-12

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

Advanced Airway Management in patients undergoing general anaesthesia

Interventions

Group 1: Use and evaluation of Ambu® AuraGain™ laryngeal mask as airway device Group 2: Use and evaluation of Flexicare® LarySeal Pro™ laryngeal mask as airway device

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Elective surgery under anesthesia - Use of LAMA as advanced airway device - Written form of consent

Exclusion criteria

Exclusion criteria: - Primarily planned endotracheal intubation - Contraindications for a LAMA - Pregnancy - Lack of capacity to give consent

Design outcomes

Primary

Measure	Time frame
Oropharyngeal leakage pressure (OLP) after placing laryngeal mask depending on randomized group	—

Secondary

Measure	Time frame
• Primary success rate of placement • Number of attempts until success • Number and category of complications • Leakage and ventilation pressure after LAMA insertion • Leakage and ventilation pressure at start of surgery • Subjective perception of difficulty of insertion	—

Countries

Germany

Contacts

Public ContactThomas Palmaers

Klinik für Anästhesiologie und Intensivmedizin, Medizinische Hochschule Hannover

palmaers.thomas@mh-hannover.de0511/532 2294

Outcome results

None listed

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