Evaluation of the EZ Blocker

Thoracic Surgery Clinical Trial

Official title:

Prospective Randomized Clinical Trial for Single-Lung-Ventilation Comparing Double-Lume Tube and the EZ-Blocker®

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01171560
• Other study ID #: 096/2010
• Status: Unknown status
• Phase: Phase 4
• First received: July 27, 2010
• Last updated: August 11, 2010
• Start date: June 2010
• Est. completion date: August 2010

Study information

• Verified date: May 2010
• Source: Medical University of Vienna
• Contact: Kurt Rützler, M.D.
• Phone: 00436643855257
• Email: kurt.ruetzler[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 40
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Intubation
• One-lung Ventilation
• Thoracic Surgery

Intervention

Procedure:
• endotracheal intubation
The patients will be randomized to one of two groups: EZ Blocker or conventional double lume tube. After induction of anesthesia, intubation using respective device will be performed in dorsal position.

Locations

Country	Name	City	State
Austria	General Hospital of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from intubation to ventilation:	is intubation and achieving lung separation faster using a conventional double-lung-tube or using the EZ-Blocker ?	5 minutes
Secondary	postoperative sore throat or croakiness	Documentation of sore throat and croakiness by questioning the patients the day after surgery	2 minutes
Secondary	resistance to dislocation	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?	10 minutes
Secondary	Peripheral oxygen saturation (SpO2)	Decrease of Peripheral oxygen saturation (SpO2) (in min) under 90% during the hole surgery	3 hours