Incidence of Adverse Airway Events in High Risk Patients Undergoing Upper GI Endoscopy Under Anesthesia

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

TERMINATED

Total Enrollment

224 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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SEDLine Accoustic Respiratory Monitor RAD87 Adverse Events Advanced Endoscopic Procedures

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* All the patients considered as high risk (see above) or undergoing an advanced upper GI procedure (see above) will be included. This is the prospective analysis of the data that is collected and stored in the monitors. We will be using the massimo Pulse oximeter ,masimo acoustic respiratory monitor and Masimo SED line Brain function monitors that allows electronic storage and retrieval of information.
* Postprocedure analysis of the data will not influence the patient care.