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

NCT02698007 | Completed DMC

• 1 other identifier: 0690-15-RMC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Disease Undergoing Elective Bronchoscopy.; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (3)

• pulse oximetry <90%,

  during bronchoscopy procedure

• Percutaneous Carbon Dioxide >55%,

  during bronchoscopy procedure

• arrhythmia by ecg monitoring.

  during bronchoscopy procedure

Study Arms (2)

without lma

NO INTERVENTION

standard fiberoptic bronchoscopy without lma

with lma

EXPERIMENTAL

fiberoptic bronchoscopy with the use of lma

Device: Laryngeal Mask Airway (LMA)

Interventions

Laryngeal Mask Airway (LMA) DEVICE

Fiberoptic bronchoscopy with the use of LMA

with lma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women and special groups will not be included in the study.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Pulmonary Institute,Rabin Medical Center

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Laryngeal Masks

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: March 3, 2016
• Study Start: April 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 14, 2016

Record last verified: 2016-02

Locations

IL (1)