Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04159116
Other study ID # TRE2019-EGD01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 4, 2019
Est. completion date March 19, 2020

Study information

Verified date March 2021
Source Envision Healthcare Scientific Intelligence, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date March 19, 2020
Est. primary completion date March 19, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Prophylactic suctioning when clinically indicated
Suctioned prophylactically when clinically indicated by copious secretions, coughing, choking or desaturatation

Locations

Country Name City State
United States Three Rivers Endoscopy Moon Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Envision Healthcare Scientific Intelligence, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of laryngospasm during EGDs Determine if prophylactic suctioning after sedation but prior to introduction of endoscope changes the incidence of laryngospasm during EGDs. 2 hours
Primary 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). 2 hours
Secondary 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. 2 hours
Secondary Identify the various causes of hypoxemia during EGD These risk include apnea, hypoventilation, laryngospasm, or other cause of airway obstruction 2 hours
See also
  Status Clinical Trial Phase
Suspended NCT03628560 - Alternate Methodology of Pulse Oximeter Validation N/A
Completed NCT02866578 - Open Lung Protective Ventilation in Cardiac Surgery N/A
Recruiting NCT06139081 - Oxygen Delivery Methods of Nasal Catheter on the Incidence of Hypoxemia in Patients With Painless Gastroscopy N/A
Not yet recruiting NCT05964309 - Pre-oxygenation in Sitting Position and Oxygen Reserve Index N/A
Completed NCT00740220 - Reproducibility of 6 Minute Walk Tests for Oxygen Desaturation N/A
Completed NCT00675415 - Does Capnography Prevent Hypoxemia During Endoscopic Retrograde Cholangiopancreatography and Endoscopic Ultrasound? N/A
Completed NCT04557605 - Effects of a Face Mask on Oxygenation During Exercise N/A
Active, not recruiting NCT05479929 - Work of Breathing Assessment in Triage Scale
Recruiting NCT05422430 - Rebreathing-induced Hypoxia and Glucose Levels N/A
Recruiting NCT03009643 - Salvage Treatment of Inhaled Nitric Oxide in Patients With Refractory Hypoxemia After Aortic Surgery N/A
Completed NCT01949012 - Capnography Monitoring During Intravenous Conscious Sedation Sedation With Midazolam for Oral Surgery N/A
Completed NCT01477450 - Comparison of Oxygen Delivery Devices for Reversal of Altitude-Induced Hypoxemia in Normal Subjects N/A
Completed NCT01470170 - Regimen of Alfentanil in Propofol Sedative Fibro-bronchoscopy Phase 4
Recruiting NCT06085859 - Anesthesia Endoscope Mask is Applied to Sedation Upper Gastrointestinal Endoscopic Diagnosis and Treatment N/A
Recruiting NCT03969615 - SuperNO2VA™ and General Anesthesia Postoperative Care N/A
Completed NCT02554110 - Peripheral Nerve Stimulation to Reduce Hypoxic Events N/A
Completed NCT04998253 - Effects in Oxygenation and Hypoxic Pulmonary Vasoconstriction in ARDS Secondary to SARS-CoV2 Early Phase 1
Completed NCT04566419 - poStoperative Anesthesia Care: Facial Mask vs Hfnc and Thoracic Ultrasound for Reduction of Atelectasis Incidence N/A
Recruiting NCT04079465 - Automated Oxygen Control by O2matic to Patients Admitted With Acute Hypoxemia N/A
Recruiting NCT06022523 - Accuracy of Pulse Oximeters With Profound Hypoxia N/A