- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01240239
Comparison of Telemedicine Evaluation to Standard Evaluation Methods for Pre-Anesthesia Consultation
November 28, 2016 updated by: Richard Applegate, Loma Linda University
The purpose of the study is to evaluate different methods of pre-anesthesia consultation, with the aim of improving the day of surgery experience for the patient.
In this study, we will use a telephone consultation, an in-person consultation, and a telemedicine consultation, which involves television cameras and monitors that allow live two-way communication for the pre-anesthesia consultation.
The reason for this study is to evaluate the use of telemedicine for the pre-anesthesia consultation.
Patients and anesthesiologists have been highly satisfied in previous studies using pre-anesthesia telemedicine consultation.
In this study, we will examine a larger group of patients, as previous studies have studied smaller groups of patients.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Redlands, California, United States, 92374
- Orange Tree Lane Otolaryngology Offices
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Subjects scheduled for ENT surgery.
Description
Inclusion Criteria:
- Patients between the ages of 18 and 89 who are scheduled for otolaryngologic procedures and pre-anesthesia consultation.
Exclusion Criteria:
Lack of consent; inability to understand English-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
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telephone group
The telephone group must be healthy adults scheduled for an ENT surgery.
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telemedicine group
This group if qualified will randomly be chosen to be in the telemedicine group.
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pre-anesthesia consultation
This will be the group that will be randomized to the pre-anesthesia clinic.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison Of Telemedicine Evaluation To Standard Evaluation Methods For Pre-Anesthesia Consultation
Time Frame: about 1 month
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Primary outcomes include surgical cancellation rate, delays the day of surgery secondary to inadequate pre-op evaluation, adequacy of the airway, respiratory, and cardiovascular exams, and intra-op and post-op complications.
Patient data will include age, gender, ASA Physical Status and type of surgery.
The length of the PACE appointment and the number of days prior to surgery the PACE appointment was conducted will be noted.
Patient satisfaction with the will be evaluated.
|
about 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
November 10, 2010
First Submitted That Met QC Criteria
November 12, 2010
First Posted (Estimate)
November 15, 2010
Study Record Updates
Last Update Posted (Estimate)
November 29, 2016
Last Update Submitted That Met QC Criteria
November 28, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 59305
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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