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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04159116
Other study ID # TRE2019-EGD01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 4, 2019
Est. completion date March 19, 2020

Study information

Verified date March 2021
Source Envision Healthcare Scientific Intelligence, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Prophylactic suctioning when clinically indicated
Suctioned prophylactically when clinically indicated by copious secretions, coughing, choking or desaturatation

Locations

Country Name City State
United States Three Rivers Endoscopy Moon Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Envision Healthcare Scientific Intelligence, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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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