Hypoxemia Clinical Trial
Official title:
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)
Verified date | March 2021 |
Source | Envision Healthcare Scientific Intelligence, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 57 |
Est. completion date | March 19, 2020 |
Est. primary completion date | March 19, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Three Rivers Endoscopy | Moon | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Envision Healthcare Scientific Intelligence, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | Identify the various causes of hypoxemia during EGD | These risk include apnea, hypoventilation, laryngospasm, or other cause of airway obstruction | 2 hours |
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