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Evaluation of gastric insufflation in second generation laryngeal masks (Ambu®AuraGain™ and i-gel®) with and without placement of a gastric tube.

Evaluation of gastric insufflation in second generation laryngeal masks (Ambu®AuraGain™ and i-gel®) with and without placement of a gastric tube. - LUMA2

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00025000
Enrollment
152
Registered
2021-04-16
Start date
2021-04-18
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

gastric insufflation

Interventions

Group 1: Ventilation manoeuvre with inserted gastric tube. After induction of anaesthesia, one of the two second generation laryngeal masks (Ambu Aura gain or i-gel) would be inserted. Followed by ins

Sponsors

Universitätsklinikum FreiburgKlinik für Anästhesiologie und Intensivmedizin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: patients schedueld for elective surgery with general anaesthesia and planed airway management with a laryngeal mask

Exclusion criteria

Exclusion criteria: missing informed consent to participate to the clinical study age less than 18 years physical status more than three according to the classification of the American Society of Anaesthesiologists acute gastrointestinal complaints, chronic gastrointestinal disease, former surgery on the upper gastrointestinal tract or reflux disease uncontrolled diabetes end-stage kidney disease known airway pathology end-stage restrictive lung disease severe neurodegenerative disorders pregnancy BMI more than 50 kg/m²

Design outcomes

Primary

MeasureTime frame
Comparisson of gastric insufflation during meachnical ventilation with increasing peak airway pressures with an without inserted gastric drain tube.

Secondary

MeasureTime frame
oropharyngeal leak pressure, postoperative oropharyngeal discomfort

Countries

Germany

Contacts

Public ContactJohannes Hell

Universitätsklinikum FreiburgKlinik für Anästhesiologie und Intensivmedizin

Johannes.Hell@uniklinik-freiburg.de0049 761 270 23060

Outcome results

None listed

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