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Completed

NCT Number: NCT02698007

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pulmonary Institute,Rabin Medical Center

Petah Tikva, 49100, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laryngeal Mask Airway (LMA)

Device

Fiberoptic bronchoscopy with the use of LMA

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 3, 2016
Registry last updated
Oct 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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