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

Chronic Obstructive Pulmonary Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02698007
• Other study ID #: 0690-15-RMC
• Status: Completed
• Phase: N/A
• First received: February 4, 2016
• Last updated: October 13, 2016
• Start date: April 2016
• Est. completion date: October 2016

Study information

• Verified date: February 2016
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiration Disorders
• Respiratory Disease Undergoing Elective Bronchoscopy.
• Respiratory Tract Diseases

Intervention

Device:
• Laryngeal Mask Airway (LMA)
Fiberoptic bronchoscopy with the use of LMA

Locations

Country	Name	City	State
Israel	Pulmonary Institute,Rabin Medical Center	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pulse oximetry <90%,		during bronchoscopy procedure	No
Primary	Percutaneous Carbon Dioxide >55%,		during bronchoscopy procedure	No
Primary	arrhythmia by ecg monitoring.		during bronchoscopy procedure	No