Evaluation of the EZ Blocker
- Conditions
- IntubationThoracic SurgeryOne-lung Ventilation
- Interventions
- Procedure: endotracheal intubation
- Registration Number
- NCT01171560
- Lead Sponsor
- Medical University of Vienna
- Brief Summary
In anesthetized patients the airway needs to be secured due to lack of protective reflexes. Golden standard is the endotracheal intubation. In patients undergoing lung surgery single lung ventilation is essential. In these cases a double lume tube is commonly used. The double lume tube has a proximal tracheal and a distal bronchial end reaching into the left or the right side of the lung dependant of the model of the tube. Thus it is possible to operate on one collapsed side of the lung while ventilating the other side.
Due to length and stiffness resulting of the construction of the device more side effects than after intubation with a conventional single lumen tube is expected. Possible side effects may be bleeding, swelling, sore throat or croakiness.
The EZ-Blocker is a new device promising to overcome these side effects. The EZ-Blocker is a device placing a balloon into one bronchus to be able to provide single lung ventilation like the double lume tube. However, the EZ-Blocker is a catheter pushed through a conventional single lume tube after intubation with a hook on one and a balloon on the other distal end. The hook prevents the device from being pushed too far to be able to harm the lung. Inside the EZ-Blocker is a small lumen able to deflate the lung which is blocked with the balloon. The device is easily positioned using a bronchoscope and when the anaesthesiologists confirmed the correct position of the device, the balloon can be inflated and deflated as needed.
Due to the easier approach the investigators expect less side effects as mentioned earlier using the EZ-Blocker compared to the double lume tube. As well the stress caused by intubation may be reduced.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- Elective surgery
- thoracic surgery with requiring single lung ventilation in lateral position
- ASA Status 1-3
- Oral and written consent to participation
- Age 18- 90
- Contraindications against placing a double lume tube, like tracheal lesions, etc.
- Thoracic surgery within the last four weeks
- Any form of infection (Pneumonia, Pleural empyema) or suspected Tbc
- BMI higher than 45
- Patients with a previous diagnoses or suspected difficult airway
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EZ Blocker endotracheal intubation Patients assigned to the EZ group will be intubated using a conventional tube in an adequate size as it is standard of care and single lung ventilation will be provided using the EZ-Blocker. Double lumen tube endotracheal intubation The patients assigned to the "double lume tube" group will be intubated using the double lume tube in an adequate size as it is standard of care.
- Primary Outcome Measures
Name Time Method Time from intubation to ventilation: 5 minutes is intubation and achieving lung separation faster using a conventional double-lung-tube or using the EZ-Blocker ?
- Secondary Outcome Measures
Name Time Method postoperative sore throat or croakiness 2 minutes Documentation of sore throat and croakiness by questioning the patients the day after surgery
resistance to dislocation 10 minutes Which device, double-lung-tube or EZ-Blocker, is more resistant to dislocation in endotracheal/endobronchial position, especially when the patient is moved from dorsal to lateral position?
Peripheral oxygen saturation (SpO2) 3 hours Decrease of Peripheral oxygen saturation (SpO2) (in min) under 90% during the hole surgery
Trial Locations
- Locations (1)
General Hospital of Vienna
🇦🇹Vienna, Austria