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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02698007
Enrollment
100
Registered
2016-03-03
Start date
2016-04-30
Completion date
2016-10-31
Last updated
2016-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Disease Undergoing Elective Bronchoscopy., Chronic Obstructive Pulmonary Disease

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.

Interventions

Fiberoptic bronchoscopy with the use of LMA

Sponsors

Rabin Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Percutaneous Carbon Dioxide >55%,during bronchoscopy procedure
arrhythmia by ecg monitoring.during bronchoscopy procedure
pulse oximetry <90%,during bronchoscopy procedure

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026