Airway Management
Conditions
Keywords
Airway Morbidity
Brief summary
A interventional, non-randomized, controlled study to evaluate the revised iLTS-D2 in anesthetized patients.
Detailed description
The revised Intubation laryngeal tube - disposable (iLTS-D) is a refined laryngeal tube, which allows a secondary intubation over the inserted laryngeal tube. The present study should reveal the effectiveness and practicability in anesthetized patients in the operation room.
Interventions
DEVICEEffectiveness
Effectiveness and Practicability in anesthetized patient under controlled conditions
Sponsors
Johannes Gutenberg University Mainz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* elective surgery patients under general Anesthesia
Exclusion criteria
* Age \<18 years * Existing pregnancy * Lack of consent * inability to consent * emergency patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insertion time LT | in 30 seconds | Insertion of the laryngeal tube |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insertion time ET | in 60 seconds | Insertion of the endotracheal tube |
| Rate of successful Intubation attempts | through study completion, an average of 120 seconds | successful insertion and tracheal intubation |
| hemodynamics MAP | through study completion, an average of 360 seconds | changes in MAP (mmHg) during cuff insufflation of laryngeal tube |
| hemodynamics Freq | through study completion, an average of 360 seconds | changes in heart frequency (bpm) |
| hemodynamics rO2 | through study completion, an average of 360 seconds | changes in cerebral oxygenation (percent) |
Countries
Germany
Outcome results
None listed