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OpenTrials
Completed

NCT Number: NCT04159116

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

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.

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Key information

Conditions

Laryngospasm Hypoxemia Hypoxia Laryngeal Diseases Laryngismus Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Vocal Cord Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Three Rivers Endoscopy

Moon Township, Pennsylvania, 15108, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prophylactic suctioning when clinically indicated

Other

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

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

  2. Identify the various causes of hypoxemia during EGD

    Time frame: 2 hours

    These risk include apnea, hypoventilation, laryngospasm, or other cause of airway obstruction

Sponsors and collaborators

Lead sponsor

Envision Healthcare Scientific Intelligence, Inc.

Other

Registry information

Official study title

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)

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 12, 2019
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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