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

Not Applicable

Completed

• Conditions: Hypoxemia; Laryngospasm
• Interventions: Other: Prophylactic suctioning when clinically indicated

• Registration Number: NCT04159116
• Lead Sponsor: Envision Healthcare Scientific Intelligence, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-04
• Study First Submitted: 2019-11-07
• Study First Submitted QC: 2019-11-07
• Study First Posted: 2019-11-12
• Primary Completion: 2020-03-19
• Study Completion: 2020-03-19
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suctioned Prior to Endoscope	Prophylactic suctioning when clinically indicated	This group will be suctioned prophylactically after sedation but prior to introduction of endoscope.
Standard of Care	Prophylactic suctioning when clinically indicated	This group will be suctioned by anesthesia providers when clinically indicated by copious secretions, coughing, choking or desaturation.

Primary Outcome Measures

Name	Time	Method
Identify risk factors for the development of hypoxemia during EGD	2 hours	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).
Incidence of laryngospasm during EGDs	2 hours	Determine if prophylactic suctioning after sedation but prior to introduction of endoscope changes the incidence of laryngospasm during EGDs.

Secondary Outcome Measures

Name	Time	Method
Incidence of copious secretions, choking, desaturation, and shortened or aborted procedures	2 hours	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.
Identify the various causes of hypoxemia during EGD	2 hours	These risk include apnea, hypoventilation, laryngospasm, or other cause of airway obstruction

Trial Locations

Locations (1)

Three Rivers Endoscopy; 🇺🇸 Moon, Pennsylvania, United States