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Study on the tolerance of different supraglottic airway devices during anesthetic emergence

Study on the tolerance of different supraglottic airway devices during anesthetic emergence - SADDEM Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00032623
Enrollment
480
Registered
2023-09-06
Start date
2023-10-01
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

Tolerance of supraglottic airway devices following general anesthesia

Interventions

Group 1: Tolerance of LTS-D laryngeal tube during anesthetic emergence Group 2: Tolerance of i-gel supraglottic airway during anesthetic emergence Group 3: Tolerance of LMA Supreme during anesthetic e

Sponsors

Bundeswehrzentralkrankenhaus Koblenz
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Presence of written informed consent for study participation. - No previous illnesses or pre-existing conditions warranting an ASA classification = 4. - Patients who do not qualify for urgent or emergency intervention classification - Patients who are receiving supraglottic airway protection - Patients with unrestricted certainty about the ability to consent or in whom the ability to consent is present. - Patients who are not expected to have a difficult airway based on the premedication interview, Mallampati score and 3-3-2 rule.

Exclusion criteria

Exclusion criteria: - Lack of patient consent - Lack of informed consent and privacy agreement - Pregnancy - Pre-existing conditions that have an ASA classification of 4 or higher. - Patients undergoing urgent or emergency procedures - Patients receiving endotracheal airway protection - Patients with an expected difficult airway - Patients in whom there is doubt as to their ability to consent or who do not have the ability to consent. - Patients who require Rapid Sequence Induction (RSI) airway management.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with intolerance symptoms in the comparison groups immediately during anesthesia emergence until extubation (=T3). Tolerance behavior: defined as "absence" of gagging, coughing, defensive movements of the extremities, tachycardia > 20% of resting value, and persistent apnea/patient-ventilator dyssynchrony.

Secondary

MeasureTime frame
Insertion time of supraglottic airway devices (SGA) (=T1) during anesthesia induction with the number of placement attempts, gastric insufflation after successful anesthesia induction and placement of SGA (=T2). Hoarseness, dysphagia, oropharyngeal pain recorded with NRS and blood traces after anesthesia in the recovery room (=T4).

Countries

Germany

Contacts

Public ContactFrederik Rabenschlag

Bundeswehrzentralkrankenhaus Koblenz

frederikrabenschlag@bundeswehr.org+49 261 281 30891

Outcome results

None listed

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