Evaluation of the EZ Blocker

NCT01171560 | Unknown Phase 4

• 1 other identifier: 096/2010
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation; Thoracic Surgery; One-lung Ventilation

Keywords

EZ Blocker; Double-lumen Tube; Airway; thoracic surgery; time for intubation; blind insertion; conditions of surgery; postoperative sore throat; postoperative hoarseness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• postoperative sore throat or croakiness

  2 minutes

• resistance to dislocation

  10 minutes

• Peripheral oxygen saturation (SpO2)

  3 hours

Study Arms (2)

EZ Blocker

ACTIVE COMPARATOR

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.

Procedure: endotracheal intubation

Double lumen tube

ACTIVE COMPARATOR

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.

Procedure: endotracheal intubation

Interventions

endotracheal intubation PROCEDURE

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.

Double lumen tube; EZ Blocker

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

General Hospital of Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

Related Publications (1)

• Ruetzler K, Grubhofer G, Schmid W, Papp D, Nabecker S, Hutschala D, Lang G, Hager H. Randomized clinical trial comparing double-lumen tube and EZ-Blocker for single-lung ventilation. Br J Anaesth. 2011 Jun;106(6):896-902. doi: 10.1093/bja/aer086. Epub 2011 Apr 14.

  PMID: 21493621 DERIVED

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques

Central Study Contacts

Kurt Rützler, M.D.

CONTACT

00436643855257; kurt.ruetzler@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 27, 2010
• First Posted: July 28, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 12, 2010

Record last verified: 2010-05

Locations

AU (1)