Evaluation of the EZ Blocker

Medical University of Vienna

Status and phase: Unknown; Phase 4

Conditions: One-lung Ventilation; Intubation; Thoracic Surgery

Treatments: Procedure: endotracheal intubation

Study type: Interventional

Funder types: Other

Identifiers

NCT01171560

096/2010

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

EZ Blocker

Active Comparator group

Description:

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.

Treatment:

Procedure: endotracheal intubation

Double lumen tube

Active Comparator group

Description:

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.

Treatment:

Procedure: endotracheal intubation