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NCT02011607 · ClinicalTrials.gov registry record
Incidence of Adverse Airway Events in High Risk Patients Undergoing Upper GI Endoscopy Under Anesthesia
A clinical trial, sponsored by University of Pennsylvania.
- Terminated
- Registry status
- 224
- Enrollment target
NCT02011607: Clinical Trial study, sponsored by University of Pennsylvania.
NCT02011607 is a clinical trial that was terminated before completion, run by University of Pennsylvania. The registered enrollment target is 224 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02011607 was terminated before completion, sponsored by University of Pennsylvania.
- TERMINATED
- Registry status
- 224 participants
- Enrollment target
Study Summary
We propose to collect the data of vital signs and anesthesia medications administered in a subcategory of patients coming for anesthesia for upper GI endoscopy. This data will be analyzed to see any relation between the preoperative risk factors, procedure, type of anesthesia and the airway intervention. The adverse events that will be automatically recorded and later analyzed will be number of apnea episodes (described as no respiration for at least 30 seconds) duration of each apnea, number and duration of each desaturation event (oxygen saturation as measured by the pulse oximeter). A pulse oximeter saturation of less than 93 percent and lasting 30 seconds will be considered as a desaturation event. The airway interventions that will be recorded will be anything other than considered being routine. This includes LMA insertion, endotracheal intubation and the need to withdraw gastroscope to facilitate face mask ventilation. We also propose to monitor their awareness/depth of sedation/depth of anesthesia levels. This will be done using a monitor that analyses brain waves and gives an idea of sleep (anesthesia) depth. We can then see any correlation between any unwanted events and the sleep depth.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2013-01 |
| Est. Completion | 2018-12-31 |
Why NCT02011607 stopped before completion
NCT02011607 is an observational study that tracks outcomes without assigning an intervention. The registered 224 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02011607 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02011607 about?
NCT02011607 is a clinical study titled "Incidence of Adverse Airway Events in High Risk Patients Undergoing Upper GI Endoscopy Under Anesthesia". We propose to collect the data of vital signs and anesthesia medications administered in a subcategory of patients coming for anesthesia for upper GI endoscopy. This data will be analyzed to see any relation between the preoperative risk factors, procedure, type of anesthesia and the airway interven...
What is the current status of trial NCT02011607?
This trial is currently terminated. The enrollment target is 224 participants. The study started on 2013-01. Estimated completion is 2018-12-31.
Who is sponsoring clinical trial NCT02011607?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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