Safety and Benefits of Using Laryngeal Mask Airway to Keep Airway Potency During Fiber-optic Bronchoscopy
|ClinicalTrials.gov Identifier: NCT02698007|
Recruitment Status : Completed
First Posted : March 3, 2016
Last Update Posted : October 14, 2016
Bronchoscopy is a method of diagnosis and treatment of common respiratory diseases and lung recognized for many years.
Since the action takes place in the airways and in light of the use of sedation, when performing, the procedure requires caution to keep potent airway and breathing sufficient enough.
Most of the bronchoscopy done without the aid of equipment for advanced airway protection. During the operation done monitoring hemodynamics: such as blood pressure, pulse and respiratory such as percutaneous oxygen saturation and carbon dioxide.
Laryngeal Mask Airway (LMA) - is a tool that has been shown to be effective in securing of airway respiratory activity during positive-pressure ventilation.
Several studies have shown that the use of LMA is a convenient and safe while performing bronchoscopy for airways and lungs. However, most of the studies were for certain patient groups such as children, immuno-compromised patients.
Or benefits and safety LMA in front of intubation during bronchoscopy.
Our aim to assess the safety and efficacy LMA in not mechanically ventilated patients undergoing flexible elective bronchoscopy .
Another objective, to examine whether there is a special group of patients enjoy the LMA more than others.
Patients will be divided randomly into two groups alternately by order, one patient study group and the next one to control.
Study group : LMA is inserted under sedation and used during the procedure.
Control group - performing bronchoscopy under sedation without LMA.
About 50 people are needed each group.
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Disease Undergoing Elective Bronchoscopy. Chronic Obstructive Pulmonary Disease||Device: Laryngeal Mask Airway (LMA)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
No Intervention: without lma
standard fiberoptic bronchoscopy without lma
Experimental: with lma
fiberoptic bronchoscopy with the use of lma
Device: Laryngeal Mask Airway (LMA)
Fiberoptic bronchoscopy with the use of LMA
- pulse oximetry <90%, [ Time Frame: during bronchoscopy procedure ]
- Percutaneous Carbon Dioxide >55%, [ Time Frame: during bronchoscopy procedure ]
- arrhythmia by ecg monitoring. [ Time Frame: during bronchoscopy procedure ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698007
|Pulmonary Institute,Rabin Medical Center|
|Petach Tikva, Israel, 49100|