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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02698007
Recruitment Status : Completed
First Posted : March 3, 2016
Last Update Posted : October 14, 2016
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

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.


Condition or disease Intervention/treatment Phase
Respiratory Disease Undergoing Elective Bronchoscopy. Chronic Obstructive Pulmonary Disease Device: Laryngeal Mask Airway (LMA) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : April 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Arm Intervention/treatment
No Intervention: without lma
standard fiberoptic bronchoscopy without lma
Experimental: with lma
fiberoptic bronchoscopy with the use of lma
Device: Laryngeal Mask Airway (LMA)
Fiberoptic bronchoscopy with the use of LMA




Primary Outcome Measures :
  1. pulse oximetry <90%, [ Time Frame: during bronchoscopy procedure ]
  2. Percutaneous Carbon Dioxide >55%, [ Time Frame: during bronchoscopy procedure ]
  3. arrhythmia by ecg monitoring. [ Time Frame: during bronchoscopy procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698007


Locations
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Israel
Pulmonary Institute,Rabin Medical Center
Petach Tikva, Israel, 49100
Sponsors and Collaborators
Rabin Medical Center
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Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02698007    
Other Study ID Numbers: 0690-15-RMC
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases