Evaluation of the EZ Blocker

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Clinical Comparison of Two New Bronchial Blockers vs. Double Lumen Tubes in One Lung Ventilation

NCT02983149

Thoracic Surgery, Lung Isolation

COMPLETED NA

Multicenter Study of EasyTube® Compared to Endotracheal Tube in General Anesthesia

NCT02359630

Airway Morbidity

COMPLETED PHASE3

Comparison of Double-lumen Tube Intubation Between Fiberoptic Bronchoscopy and Video Laryngoscope

NCT07241208

One Lung Ventilation in Thoracic Surgery

RECRUITING NA

The Effects of Flexible Intubating Stylet in the Accurate Placement of Double-lumen Endobronchial Tube

NCT02364622

Intubation Complication Intubation, Difficult

COMPLETED NA

Insertion Time Over Fiberoptic Bronchoscope of Double Lumen Tube and Single Lumen Tube

NCT03173443

Intubation;Difficult

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intubation Thoracic Surgery One-lung Ventilation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EZ Blocker

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.

Group Type ACTIVE_COMPARATOR

endotracheal intubation

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

endotracheal intubation

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No