Clinical Evaluation of the Revised iLTS-D2
- Conditions
- Airway Management
- Interventions
- Device: Effectiveness
- Registration Number
- NCT03942809
- Lead Sponsor
- Johannes Gutenberg University Mainz
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- elective surgery patients under general Anesthesia
- Age <18 years
- Existing pregnancy
- Lack of consent
- inability to consent
- emergency patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Effectiveness Effectiveness Evaluate the Effectiveness in insertion success, insertion times, influence of respiratory, cardiac and cerebral circulation
- Primary Outcome Measures
Name Time Method Insertion time LT in 30 seconds Insertion of the laryngeal tube
- Secondary Outcome Measures
Name Time Method hemodynamics rO2 through study completion, an average of 360 seconds changes in cerebral oxygenation (percent)
Rate of successful Intubation attempts through study completion, an average of 120 seconds successful insertion and tracheal intubation
hemodynamics Freq through study completion, an average of 360 seconds changes in heart frequency (bpm)
Insertion time ET in 60 seconds Insertion of the endotracheal tube
hemodynamics MAP through study completion, an average of 360 seconds changes in MAP (mmHg) during cuff insufflation of laryngeal tube
Trial Locations
- Locations (1)
Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
🇩🇪Mainz, Rhineland-Palatinate, Germany