Prevention and Treatment of Laryngospasm and Hypoxemia Based on Risk Factors in Adult Outpatients Undergoing EGD

Study Overview
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Brief Summary
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The purpose of this study is to identify patient and provider-chosen factors that put patients at risk for the development of hypoxemia (oxygen saturation < 90% for 5 seconds) during endoscopy and to use this knowledge to develop a treatment protocol for specific causes of hypoxemia in adult esophagogastroduodenoscopy outpatients.

Official Title
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Development of a Protocol for Prevention and Treatment of Laryngospasm and Other Causes of Hypoxemia Based on Identified Risk Factors in Adult Outpatients Undergoing Esophagogastroduodenoscopy (EGD) Under Monitored Anesthesia Care (MAC)

Conditions
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Laryngospasm, Hypoxemia

Intervention / Treatment
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* Other: Prophylactic suctioning when clinically indicated


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over the age of 18 years English speaking Mentally competent to sign their own consent for treatment Exclusion Criteria: Poor incisor teeth stability Anticipated procedure of greater than 30 minutes History of facial or oral surgery and a baseline oxygen saturation of less than 95% on room air

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suctioned Prior to Endoscope<br>This group will be suctioned prophylactically after sedation but prior to introduction of endoscope. | Other: Prophylactic suctioning when clinically indicated<br>* Suctioned prophylactically when clinically indicated by copious secretions, coughing, choking or desaturatation<br>|
| Other: Standard of Care<br>This group will be suctioned by anesthesia providers when clinically indicated by copious secretions, coughing, choking or desaturation. | Other: Prophylactic suctioning when clinically indicated<br>* Suctioned prophylactically when clinically indicated by copious secretions, coughing, choking or desaturatation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of laryngospasm during EGDs | Determine if prophylactic suctioning after sedation but prior to introduction of endoscope changes the incidence of laryngospasm during EGDs. | 2 hours | 
| Identify risk factors for the development of hypoxemia during EGD | These risk factors include both patient factors (ASA class, history of cardiopulmonary disease, BMI, social history, Obstructive Sleep Apnea, STOP-BANG scores and age) and provider-chosen factors (medications given, airway interventions, percent and flow of oxygen in liters per minute, and whether or not the patient was suctioned prior to or during the procedure). | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of copious secretions, choking, desaturation, and shortened or aborted procedures | Determine if prophylactic suctioning after sedation but prior to introduction of endoscope changes the incidence of copious secretions, choking, desaturation, and shortened or aborted procedures. | 2 hours | 
| Identify the various causes of hypoxemia during EGD | These risk include apnea, hypoventilation, laryngospasm, or other cause of airway obstruction | 2 hours |