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

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 19, 2020

Interventions

  • Other: Prophylactic suctioning when clinically indicated
    • Suctioned prophylactically when clinically indicated by copious secretions, coughing, choking or desaturatation

Arms, Groups and Cohorts

  • Experimental: Suctioned Prior to Endoscope
    • This group will be suctioned prophylactically after sedation but prior to introduction of endoscope.
  • Other: Standard of Care
    • This group will be suctioned by anesthesia providers when clinically indicated by copious secretions, coughing, choking or desaturation.

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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).

Secondary Measures

  • Incidence of copious secretions, choking, desaturation, and shortened or aborted procedures
    • Time Frame: 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
    • Time Frame: 2 hours
    • These risk include apnea, hypoventilation, laryngospasm, or other cause of airway obstruction

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Envision Healthcare Scientific Intelligence, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Suzanne Morrison, DNP, CRNA, Principal Investigator, Envision Healthcare

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.