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Clinical Trials/NCT04159116
NCT04159116
Completed
Not Applicable

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)

Envision Healthcare Scientific Intelligence, Inc.1 site in 1 country57 target enrollmentNovember 4, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Laryngospasm
Sponsor
Envision Healthcare Scientific Intelligence, Inc.
Enrollment
57
Locations
1
Primary Endpoint
Identify risk factors for the development of hypoxemia during EGD
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 4, 2019
End Date
March 19, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Envision Healthcare Scientific Intelligence, Inc.
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Identify risk factors for the development of hypoxemia during EGD

Time Frame: 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

Time Frame: 2 hours

Determine if prophylactic suctioning after sedation but prior to introduction of endoscope changes the incidence of laryngospasm during EGDs.

Secondary Outcomes

  • Incidence of copious secretions, choking, desaturation, and shortened or aborted procedures(2 hours)
  • Identify the various causes of hypoxemia during EGD(2 hours)

Study Sites (1)

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