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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159116
Recruitment Status : Enrolling by invitation
First Posted : November 12, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Envision Healthcare Scientific Intelligence, Inc.

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.

Condition or disease Intervention/treatment Phase
Laryngospasm Hypoxemia Other: Prophylactic suctioning when clinically indicated Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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)
Actual Study Start Date : November 4, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159116


Locations
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United States, Pennsylvania
Three Rivers Endoscopy
Moon, Pennsylvania, United States, 15108
Sponsors and Collaborators
Envision Healthcare Scientific Intelligence, Inc.
Investigators
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Principal Investigator: Suzanne Morrison, DNP, CRNA Envision Healthcare
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Responsible Party: Envision Healthcare Scientific Intelligence, Inc.
ClinicalTrials.gov Identifier: NCT04159116    
Other Study ID Numbers: TRE2019-EGD01
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Laryngismus
Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms
Vocal Cord Dysfunction
Laryngeal Diseases
Respiratory Tract Diseases
Respiration Disorders
Otorhinolaryngologic Diseases