Other Complications of Surgical and Medical ProceduresNCT02634047
Use of McGrath Videolaryngoscope to Assist Transesophageal Echocardiography Probe Insertion in Intubated Patients
A study testing conventional technique and videolaryngoscope technique in people with Other Complications of Surgical and Medical Procedures, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study is to investigate the difference in the first attempt and overall success rate of different techniques for insertion of transesophageal echocardiography. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Other Complications of Surgical and Medical Procedures
- What is being tested?
- conventional technique and videolaryngoscope technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2015to Nov 2015
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who received general anaesthesia for open heart surgeries that required transesophageal echocardiography probe insertion
Who cannot join
- patients younger than 18 years and older than 70 years
- oropharengeal infection
- esophageal injury and anatomic abnormalities
- known or predicted difficult airway
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
Antalya, 07100
About this study
Official title: Use of McGrath Videolaryngoscope to Assist Transesophageal Echocardiography Probe Insertion in Intubated Patients: A Prospective Randomized Controlled Trial
The primary aim of this study is to investigate the difference in the first attempt and overall success rate of different techniques for insertion of transesophageal echocardiography. Secondary aim is to investigate the difference of the duration of insertion using the selected technique, complications during insertion such as oropharyngeal mucosal injury and hematoma.
Read the detailed description
Eighty adult patients, who received general anaesthesia for elective open heart surgeries that required transesophageal echocardiography insertion, will be randomized by means of a computer-generated randomization order into two groups: Conventional group (Group C), and videolaryngoscope group (group VL).
Success rate of the selected technique (first attempt and overall), duration of insertion for selected technique, complications such as oropharyngeal mucosal injury and hematoma will be noted.
- Being tested
- conventional technique, videolaryngoscope technique
- Keywords
- transesophageal echocardiography, videolaryngoscope, oropharyngeal injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional techniqueDevice
transesophageal echocardiography probe was inserted using a traditional blind insertion technique.
videolaryngoscope techniqueDevice
transesophageal echocardiography probe was advanced into esophagus under direct vision using videolaryngoscope
| Study group | Role | What they receive |
|---|---|---|
| conventional technique | Active comparator | transesophageal echocardiography probe was inserted using a traditional blind insertion technique. Receives: Device: conventional technique |
| videolaryngoscope technique | Experimental | transesophageal echocardiography probe was advanced into esophagus under direct vision using videolaryngoscope Receives: Device: videolaryngoscope technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in the first attempt and overall success rate
investigate the difference in the first attempt and overall success rate (with percentage) of different techniques for insertion of transesophageal echocardiography probe.
Measured: participants will be followed from the beginning of the transesophageal echocardiography probe insertion through the mouth to the confirmation of successful insertion (10 minutes)
Secondary outcomes (1)
difference of the duration of insertion and complications during insertion
investigate the difference of the duration of insertion (in seconds) using the selected technique and complications (with number and percentage) during insertion such as oropharyngeal mucosal injury and hematoma.
Measured: participants will be followed for the duration of intraoperative period and postoperative 8 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Other Complications of Surgical and Medical ProceduresStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nılgun Kavrut Ozturk, MD, Study director, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634047
- Sponsor's protocol ID
- AntalyaTRH 009
- Status last verified
- Dec 2015
- First submitted
- 10 Dec 2015
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Chang JE, Min SW, Kim CS, Lee JM, No H, Hwang JY. Effect of Jaw Thrust on Transesophageal Echocardiography Probe Insertion and Concomitant Oropharyngeal Injury. J Cardiothorac Vasc Anesth. 2015 Oct;29(5):1266-71. doi: 10.1053/j.jvca.2015.02.003. Epub 2015 Feb 7.
PubMed 25976603Na S, Kim CS, Kim JY, Cho JS, Kim KJ. Rigid laryngoscope-assisted insertion of transesophageal echocardiography probe reduces oropharyngeal mucosal injury in anesthetized patients. Anesthesiology. 2009 Jan;110(1):38-40. doi: 10.1097/ALN.0b013e318190b56e.
PubMed 19104168Aviv JE, Di Tullio MR, Homma S, Storper IS, Zschommler A, Ma G, Petkova E, Murphy M, Desloge R, Shaw G, Benjamin S, Corwin S. Hypopharyngeal perforation near-miss during transesophageal echocardiography. Laryngoscope. 2004 May;114(5):821-6. doi: 10.1097/00005537-200405000-00006.
PubMed 15126737Hirabayashi Y, Okada O, Seo N. Airtraq laryngoscope for the insertion of a transesophageal echocardiography probe. J Cardiothorac Vasc Anesth. 2008 Apr;22(2):331-2. doi: 10.1053/j.jvca.2007.06.012. Epub 2007 Aug 22. No abstract available.
PubMed 18375345Hirabayashi Y. GlideScope-assisted insertion of a transesophageal echocardiography probe. J Cardiothorac Vasc Anesth. 2007 Aug;21(4):628. doi: 10.1053/j.jvca.2006.11.015. Epub 2007 Feb 22. No abstract available.
PubMed 17678807
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of McGrath Videolaryngoscope to Assist Transesophageal Echocardiography Probe Insertion in Intubated Patients: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02634047
- Acronym / sponsor ID
- AntalyaTRH 009
- Keywords
- transesophageal echocardiography, videolaryngoscope, oropharyngeal injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- Sep 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 17 Dec 2015 (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 primary aim of this study is to investigate the difference in the first attempt and overall success rate of different techniques for insertion of transesophageal echocardiography. Secondary aim is to investigate the difference of the duration of insertion using the selected technique, complications during insertion such as oropharyngeal mucosal injury and hematoma.
Detailed description
Eighty adult patients, who received general anaesthesia for elective open heart surgeries that required transesophageal echocardiography insertion, will be randomized by means of a computer-generated randomization order into two groups: Conventional group (Group C), and videolaryngoscope group (group VL).
Success rate of the selected technique (first attempt and overall), duration of insertion for selected technique, complications such as oropharyngeal mucosal injury and hematoma will be noted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional technique | Active comparator | Device: conventional techniquetransesophageal echocardiography probe was inserted using a traditional blind insertion technique. |
| videolaryngoscope technique | Experimental | Device: videolaryngoscope techniquetransesophageal echocardiography probe was advanced into esophagus under direct vision using videolaryngoscope |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who received general anaesthesia for open heart surgeries that required transesophageal echocardiography probe insertion
Key exclusion criteria (4 listed)
- patients younger than 18 years and older than 70 years
- oropharengeal infection
- esophageal injury and anatomic abnormalities
- known or predicted difficult airway
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional techniquetransesophageal echocardiography probe was inserted using a traditional blind insertion technique. | Device | conventional technique |
| videolaryngoscope techniquetransesophageal echocardiography probe was advanced into esophagus under direct vision using videolaryngoscope | Device | videolaryngoscope technique |
Primary outcome
difference in the first attempt and overall success rate
Time frame: participants will be followed from the beginning of the transesophageal echocardiography probe insertion through the mouth to the confirmation of successful insertion (10 minutes)
investigate the difference in the first attempt and overall success rate (with percentage) of different techniques for insertion of transesophageal echocardiography probe.
1 secondary outcome
difference of the duration of insertion and complications during insertion
Time frame: participants will be followed for the duration of intraoperative period and postoperative 8 hours.
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 17 Dec 2015.
- Background: PubMed 25976603Chang JE, Min SW, Kim CS, Lee JM, No H, Hwang JY. Effect of Jaw Thrust on Transesophageal Echocardiography Probe Insertion and Concomitant Oropharyngeal Injury. J Cardiothorac Vasc Anesth. 2015 Oct;29(5):1266-71. doi: 10.1053/j.jvca.2015.02.003. Epub 2015 Feb 7.
- Background: PubMed 19104168Na S, Kim CS, Kim JY, Cho JS, Kim KJ. Rigid laryngoscope-assisted insertion of transesophageal echocardiography probe reduces oropharyngeal mucosal injury in anesthetized patients. Anesthesiology. 2009 Jan;110(1):38-40. doi: 10.1097/ALN.0b013e318190b56e.
- Background: PubMed 15126737Aviv JE, Di Tullio MR, Homma S, Storper IS, Zschommler A, Ma G, Petkova E, Murphy M, Desloge R, Shaw G, Benjamin S, Corwin S. Hypopharyngeal perforation near-miss during transesophageal echocardiography. Laryngoscope. 2004 May;114(5):821-6. doi: 10.1097/00005537-200405000-00006.
- Background: PubMed 18375345Hirabayashi Y, Okada O, Seo N. Airtraq laryngoscope for the insertion of a transesophageal echocardiography probe. J Cardiothorac Vasc Anesth. 2008 Apr;22(2):331-2. doi: 10.1053/j.jvca.2007.06.012. Epub 2007 Aug 22. No abstract available.
- Background: PubMed 17678807Hirabayashi Y. GlideScope-assisted insertion of a transesophageal echocardiography probe. J Cardiothorac Vasc Anesth. 2007 Aug;21(4):628. doi: 10.1053/j.jvca.2006.11.015. Epub 2007 Feb 22. No abstract available.
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.
Nılgun Kavrut Ozturk, MD study director
Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional technique and videolaryngoscope technique in people with Other Complications of Surgical and Medical Procedures, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 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 17 Dec 2015. 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 Turkey (Türkiye). 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?
difference in the first attempt and overall success rate (time frame: participants will be followed from the beginning of the transesophageal echocardiography probe insertion through the mouth to the confirmation of successful insertion (10 minutes)). 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 NCT02634047, which also lists 5 linked publications.
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 17 Dec 2015.