ENT Patients Scheduled for SurgeryNCT01240239
Comparison of Telemedicine Evaluation to Standard Evaluation Methods for Pre-Anesthesia Consultation
An observational study of ENT Patients Scheduled for Surgery, run by Loma Linda University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- ENT Patients Scheduled for Surgery
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects scheduled for ENT surgery.
Who may be able to join
- Patients between the ages of 18 and 89 who are scheduled for otolaryngologic procedures and pre-anesthesia consultation.
Who cannot join
- Lack of consent; inability to understand English-
Trial locations and contacts
1 site in 1 country.
United States1 site
Orange Tree Lane Otolaryngology Offices
Redlands, California, 92374
About this study
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.
- Conditions
- ENT Patients Scheduled for Surgery
- Keywords
- Pre anesthesia consultation, telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| telephone group | The telephone group must be healthy adults scheduled for an ENT surgery. | |
| telemedicine group | This group if qualified will randomly be chosen to be in the telemedicine group. | |
| pre-anesthesia consultation | This will be the group that will be randomized to the pre-anesthesia clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison Of Telemedicine Evaluation To Standard Evaluation Methods For Pre-Anesthesia Consultation
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.
Measured: about 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ENT Patients Scheduled for SurgeryStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Applegate, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240239
- Sponsor's protocol ID
- 59305
- Status last verified
- Nov 2016
- First submitted
- 10 Nov 2010
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Applegate RL 2nd, Gildea B, Patchin R, Rook JL, Wolford B, Nyirady J, Dawes TA, Faltys J, Ramsingh DS, Stier G. Telemedicine pre-anesthesia evaluation: a randomized pilot trial. Telemed J E Health. 2013 Mar;19(3):211-6. doi: 10.1089/tmj.2012.0132. Epub 2013 Feb 5.
PubMed 23384334
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Telemedicine Evaluation to Standard Evaluation Methods for Pre-Anesthesia Consultation
- ClinicalTrials.gov ID
- NCT01240239
- Acronym / sponsor ID
- 59305
- Conditions
- ENT Patients Scheduled for Surgery
- Keywords
- Pre anesthesia consultation, telemedicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 15 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| telephone group | – | –The telephone group must be healthy adults scheduled for an ENT surgery. |
| telemedicine group | – | –This group if qualified will randomly be chosen to be in the telemedicine group. |
| pre-anesthesia consultation | – | –This will be the group that will be randomized to the pre-anesthesia clinic. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects scheduled for ENT surgery.
Key inclusion criteria (1 listed)
- Patients between the ages of 18 and 89 who are scheduled for otolaryngologic procedures and pre-anesthesia consultation.
Key exclusion criteria (1 listed)
- Lack of consent; inability to understand English-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison Of Telemedicine Evaluation To Standard Evaluation Methods For Pre-Anesthesia Consultation
Time frame: about 1 month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
- Derived from this study: PubMed 23384334Applegate RL 2nd, Gildea B, Patchin R, Rook JL, Wolford B, Nyirady J, Dawes TA, Faltys J, Ramsingh DS, Stier G. Telemedicine pre-anesthesia evaluation: a randomized pilot trial. Telemed J E Health. 2013 Mar;19(3):211-6. doi: 10.1089/tmj.2012.0132. Epub 2013 Feb 5.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ENT Patients Scheduled for Surgery, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison Of Telemedicine Evaluation To Standard Evaluation Methods For Pre-Anesthesia Consultation (time frame: about 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01240239, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2016.