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

NCT ID: NCT04159116

Last Updated: 2021-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-04

Study Completion Date

2020-03-19

Brief Summary

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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

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Conditions

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Laryngospasm Hypoxemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Suctioned Prior to Endoscope

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

Group Type EXPERIMENTAL

Prophylactic suctioning when clinically indicated

Intervention Type OTHER

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.

Group Type OTHER

Prophylactic suctioning when clinically indicated

Intervention Type OTHER

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

Interventions

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Prophylactic suctioning when clinically indicated

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Envision Healthcare Scientific Intelligence, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Suzanne Morrison, DNP, CRNA

Role: PRINCIPAL_INVESTIGATOR

Envision Healthcare

Locations

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Three Rivers Endoscopy

Moon Township, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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TRE2019-EGD01

Identifier Type: -

Identifier Source: org_study_id

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