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)

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.

Study Overview

• Status: Completed
• Conditions: Hypoxemia; Laryngospasm
• Intervention / Treatment: Other: Prophylactic suctioning when clinically indicated

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Moon, Pennsylvania, United States, 15108
      • Three Rivers Endoscopy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Suctioned Prior to Endoscope; This group will be suctioned prophylactically after sedation but prior to introduction of endoscope.	Other: Prophylactic suctioning when clinically indicated; Suctioned prophylactically when clinically indicated by copious secretions, coughing, choking or desaturatation
Other: Standard of Care; This group will be suctioned by anesthesia providers when clinically indicated by copious secretions, coughing, choking or desaturation.	Other: Prophylactic suctioning when clinically indicated; Suctioned prophylactically when clinically indicated by copious secretions, coughing, choking or desaturatation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Identify the various causes of hypoxemia during EGD	These risk include apnea, hypoventilation, laryngospasm, or other cause of airway obstruction	2 hours

Collaborators and Investigators

• Sponsor: Envision Healthcare Scientific Intelligence, Inc.
• Investigators: Principal Investigator: Suzanne Morrison, DNP, CRNA, Envision Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2019
• Primary Completion (Actual): March 19, 2020
• Study Completion (Actual): March 19, 2020

Study Registration Dates

• First Submitted: November 7, 2019
• First Submitted That Met QC Criteria: November 7, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Laryngeal Diseases; Vocal Cord Dysfunction; Hypoxia; Laryngismus
• Other Study ID Numbers: TRE2019-EGD01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No