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

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Clalit Health Services

Status

Completed

Conditions

Chronic Obstructive Pulmonary Disease
Respiratory Disease Undergoing Elective Bronchoscopy.

Treatments

Device: Laryngeal Mask Airway (LMA)

Study type

Interventional

Funder types

Other

Identifiers

NCT02698007
0690-15-RMC

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

without lma
No Intervention group
Description:
standard fiberoptic bronchoscopy without lma
with lma
Experimental group
Description:
fiberoptic bronchoscopy with the use of lma
Treatment:
Device: Laryngeal Mask Airway (LMA)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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