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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.

Tracking Information
First Submitted Date  ICMJE November 7, 2019
First Posted Date  ICMJE November 12, 2019
Last Update Posted Date November 13, 2019
Actual Study Start Date  ICMJE November 4, 2019
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2019)
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: November 7, 2019)
  • Incidence of laryngospasm during EGDs [ Time Frame: 2 hours ]
    Determine if prophylactic suctioning after sedation but prior to introduction of endoscope decreases 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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2019)
  • 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 decreases 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention and Treatment of Laryngospasm and Hypoxemia Based on Risk Factors in Adult Outpatients Undergoing EGD
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Laryngospasm
  • Hypoxemia
Intervention  ICMJE Other: Prophylactic suctioning when clinically indicated
Suctioned prophylactically when clinically indicated by copious secretions, coughing, choking or desaturatation
Study Arms  ICMJE
  • Experimental: Suctioned Prior to Endoscope
    This group will be suctioned prophylactically after sedation but prior to introduction of endoscope.
    Intervention: Other: Prophylactic suctioning when clinically indicated
  • Standard of Care
    This group will be suctioned by anesthesia providers when clinically indicated by copious secretions, coughing, choking or desaturation.
    Intervention: Other: Prophylactic suctioning when clinically indicated
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: November 7, 2019)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2020
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04159116
Other Study ID Numbers  ICMJE TRE2019-EGD01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Envision Healthcare Scientific Intelligence, Inc.
Study Sponsor  ICMJE Envision Healthcare Scientific Intelligence, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Suzanne Morrison, DNP, CRNA Envision Healthcare
PRS Account Envision Healthcare Scientific Intelligence, Inc.
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP