Safety and Benefits of Using Laryngeal Mask Airway to Keep Airway Potency During Fiber-optic Bronchoscopy
Primary Purpose
Respiratory Disease Undergoing Elective Bronchoscopy., Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Laryngeal Mask Airway (LMA)
Sponsored by
About this trial
This is an interventional supportive care trial for Respiratory Disease Undergoing Elective Bronchoscopy.
Eligibility Criteria
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.
Sites / Locations
- Pulmonary Institute,Rabin Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
without lma
with lma
Arm Description
standard fiberoptic bronchoscopy without lma
fiberoptic bronchoscopy with the use of lma
Outcomes
Primary Outcome Measures
pulse oximetry <90%,
Percutaneous Carbon Dioxide >55%,
arrhythmia by ecg monitoring.
Secondary Outcome Measures
Full Information
NCT ID
NCT02698007
First Posted
February 4, 2016
Last Updated
October 13, 2016
Sponsor
Rabin Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02698007
Brief Title
Safety and Benefits of Using Laryngeal Mask Airway to Keep Airway Potency During Fiber-optic Bronchoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Disease Undergoing Elective Bronchoscopy., Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
without lma
Arm Type
No Intervention
Arm Description
standard fiberoptic bronchoscopy without lma
Arm Title
with lma
Arm Type
Experimental
Arm Description
fiberoptic bronchoscopy with the use of lma
Intervention Type
Device
Intervention Name(s)
Laryngeal Mask Airway (LMA)
Intervention Description
Fiberoptic bronchoscopy with the use of LMA
Primary Outcome Measure Information:
Title
pulse oximetry <90%,
Time Frame
during bronchoscopy procedure
Title
Percutaneous Carbon Dioxide >55%,
Time Frame
during bronchoscopy procedure
Title
arrhythmia by ecg monitoring.
Time Frame
during bronchoscopy procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Pulmonary Institute,Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Safety and Benefits of Using Laryngeal Mask Airway to Keep Airway Potency During Fiber-optic Bronchoscopy
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