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Clinical Trials/NCT02698007
NCT02698007CompletedNot Applicable

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

Rabin Medical Center1 site in 1 country100 target enrollmentStarted: April 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
arrhythmia by ecg monitoring.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

without lma

No Intervention

standard fiberoptic bronchoscopy without lma

with lma

Experimental

fiberoptic bronchoscopy with the use of lma

Intervention: Laryngeal Mask Airway (LMA) (Device)

Outcomes

Primary Outcomes

arrhythmia by ecg monitoring.

Time Frame: during bronchoscopy procedure

pulse oximetry <90%,

Time Frame: during bronchoscopy procedure

Percutaneous Carbon Dioxide >55%,

Time Frame: during bronchoscopy procedure

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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