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Comparison of the tightness of a first-generation laryngeal mask with the i-gel laryngeal mask when the head is rotated during general anesthesia - a prospective, randomized intervention study

Comparison of the tightness of a first-generation laryngeal mask with the i-gel laryngeal mask when the head is rotated during general anesthesia - a prospective, randomized intervention study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00031785
Enrollment
126
Registered
2023-04-26
Start date
2023-04-11
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

Airway management during elective surgery

Interventions

Group 1: classic Laryngeal mask Group 2: i-Gel Laryngeal mask

Sponsors

Charité - Universitätsmedizin Berlin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: = 18 years ASA I-III Planned general anaesthesia with laryngeal mask BMI = 30 kg/m2

Exclusion criteria

Exclusion criteria: Pathologies of the cervical spine Contraindications to the use of a laryngeal mask Patients who are unable to give consent Participation in another intervention study

Design outcomes

Primary

MeasureTime frame
Oropharyngeal leakage pressure (OLP) (cmH2O), this is the ventilation pressure above which a leak in the laryngeal mask becomes apparent. For this, the expiratory valve is closed (40 cmH2O) and switched to manual ventilation. The peak pressure reached until leakage corresponds to the OLP. The measurement is taken 10 minutes after induction of anaesthesia.

Secondary

MeasureTime frame
Expiratory tidal volume (ml) Leakage volume (ml) Maximum minute volume test (16) Maximum ventilation pressure (mbar) Postoperative complaints: Sore throat Hoarseness Dysphagia Soft tissue damage Tooth damage

Countries

Germany

Contacts

Public ContactSascha Treskatsch

Klinik für Anästhesie und operative Intensivmedizin, Charité Campus Benjamin Franklin

sascha.treskatsch@charite.de030 450551522

Outcome results

None listed

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