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

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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04159116

Enrollment

Registered

2019-11-12

Start date

2019-11-04

Completion date

2020-03-19

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxemia, Laryngospasm

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.

Interventions

OTHERProphylactic suctioning when clinically indicated

Suctioned prophylactically when clinically indicated by copious secretions, coughing, choking or desaturatation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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).

Secondary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026