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

Primary Purpose

Laryngospasm, Hypoxemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prophylactic suctioning when clinically indicated
Sponsored by
Envision Healthcare Scientific Intelligence, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Laryngospasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Three Rivers Endoscopy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Suctioned Prior to Endoscope

Standard of Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence of laryngospasm during EGDs
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
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

Incidence of copious secretions, choking, desaturation, and shortened or aborted procedures
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
These risk include apnea, hypoventilation, laryngospasm, or other cause of airway obstruction

Full Information

First Posted
November 7, 2019
Last Updated
March 16, 2021
Sponsor
Envision Healthcare Scientific Intelligence, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04159116
Brief Title
Prevention and Treatment of Laryngospasm and Hypoxemia Based on Risk Factors in Adult Outpatients Undergoing EGD
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 4, 2019 (Actual)
Primary Completion Date
March 19, 2020 (Actual)
Study Completion Date
March 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Envision Healthcare Scientific Intelligence, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngospasm, Hypoxemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Suctioned Prior to Endoscope
Arm Type
Experimental
Arm Description
This group will be suctioned prophylactically after sedation but prior to introduction of endoscope.
Arm Title
Standard of Care
Arm Type
Other
Arm Description
This group will be suctioned by anesthesia providers when clinically indicated by copious secretions, coughing, choking or desaturation.
Intervention Type
Other
Intervention Name(s)
Prophylactic suctioning when clinically indicated
Intervention Description
Suctioned prophylactically when clinically indicated by copious secretions, coughing, choking or desaturatation
Primary Outcome Measure Information:
Title
Incidence of laryngospasm during EGDs
Description
Determine if prophylactic suctioning after sedation but prior to introduction of endoscope changes the incidence of laryngospasm during EGDs.
Time Frame
2 hours
Title
Identify risk factors for the development of hypoxemia during EGD
Description
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).
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Incidence of copious secretions, choking, desaturation, and shortened or aborted procedures
Description
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.
Time Frame
2 hours
Title
Identify the various causes of hypoxemia during EGD
Description
These risk include apnea, hypoventilation, laryngospasm, or other cause of airway obstruction
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Morrison, DNP, CRNA
Organizational Affiliation
Envision Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Three Rivers Endoscopy
City
Moon
State/Province
Pennsylvania
ZIP/Postal Code
15108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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