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Safety and Benefits of Using Laryngeal Mask Airway to Keep Airway Potency During Fiber-optic Bronchoscopy

Not Applicable
Completed
Conditions
Chronic Obstructive Pulmonary Disease
Respiratory Disease Undergoing Elective Bronchoscopy.
Interventions
Device: Laryngeal Mask Airway (LMA)
Registration Number
NCT02698007
Lead Sponsor
Rabin Medical Center
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
100
Inclusion Criteria
  • Above 18 y.o
  • Competency to sign informed consent.
  • Room air oxygen saturation above 95%
  • Stable hemodynamically and respiratory during the start procedure.
  • Undergoing elective bronchoscopy.
Exclusion Criteria
  • Pregnant women and special groups will not be included in the study.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
with lmaLaryngeal Mask Airway (LMA)fiberoptic bronchoscopy with the use of lma
Primary Outcome Measures
NameTimeMethod
arrhythmia by ecg monitoring.during bronchoscopy procedure
pulse oximetry <90%,during bronchoscopy procedure
Percutaneous Carbon Dioxide >55%,during bronchoscopy procedure
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Pulmonary Institute,Rabin Medical Center

🇮🇱

Petach Tikva, Israel

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