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

NCT04159116 | Completed

• 1 other identifier: TRE2019-EGD01
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Laryngospasm; Hypoxemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Incidence of copious secretions, choking, desaturation, and shortened or aborted procedures

  2 hours

• Identify the various causes of hypoxemia during EGD

  2 hours

Study Arms (2)

Suctioned Prior to Endoscope

EXPERIMENTAL

This group will be suctioned prophylactically after sedation but prior to introduction of endoscope.

Other: Prophylactic suctioning when clinically indicated

Standard of Care

OTHER

This group will be suctioned by anesthesia providers when clinically indicated by copious secretions, coughing, choking or desaturation.

Other: Prophylactic suctioning when clinically indicated

Interventions

Prophylactic suctioning when clinically indicated OTHER

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

Standard of Care; Suctioned Prior to Endoscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over the age of 18 years
• English speaking
• Mentally competent to sign their own consent for treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Envision Healthcare Scientific Intelligence, Inc.: lead

Study Sites (1)

Three Rivers Endoscopy

Moon Township, Pennsylvania, 15108, United States

Location

MeSH Terms

Conditions

Laryngismus; Hypoxia

Condition Hierarchy (Ancestors)

Vocal Cord Dysfunction; Laryngeal Diseases; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Suzanne Morrison, DNP, CRNA

  Envision Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 12, 2019
• Study Start: November 4, 2019
• Primary Completion: March 19, 2020
• Study Completion: March 19, 2020
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)