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

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04159116
• Other study ID #: TRE2019-EGD01
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hypoxemia
• Hypoxia
• Laryngismus
• Laryngospasm

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