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

NCT02011607 | Terminated

• 1 other identifier: 812903
• Study Type: observational
• Target: 224
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SEDLine; Accoustic Respiratory Monitor RAD87; Adverse Events; Advanced Endoscopic Procedures

Outcome Measures

Primary Outcomes (1)

• incidence of adverse events

  during the procedure

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patints undergoing advanced endoscopic procedures

You may qualify if:

• 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.

You may not qualify if:

• Any patient who cannot give a valid consent will be excluded
• Children
• Pregnant women
• Fetuses and/or Neonates
• Prisoners

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

• Basavana G Goudra

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2013
• First Posted: December 13, 2013
• Study Start: January 1, 2013
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

US (1)