Critical IllnessVIDLARECONCT04980976
C-MAC Videolaryngoscope for Insertion of a Transesophageal Echocardiography Probe in ICU Patients
A study testing Blind insertion technique and C-MAC videolaryngoscope insertion technique in people with Critical Illness, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.
Trial summary
Transesophageal echocardiography (TEE) is commonly used in operating room (cardiac surgery), as well as in other critical care settings. A recent meta-analysis including only three randomized studies demonstrated that the use of a videolaryngoscope for transesophageal echocardiography probe insertion in anesthetized… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- Blind insertion technique and C-MAC videolaryngoscope insertion technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 19 Aug 2021to 1 May 2023
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICU intubated patients that require transesophageal echocardiography probe insertion
Who cannot join
- patients younger than 18 years and older than 85 years
- oropharengeal infection
- esophageal injury and anatomic abnormalities
- Consent refusal for participating in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: C-MAC Videolaryngoscope for Insertion of a Transesophageal Echocardiography Probe in ICU Patients. A Randomized Controlled Trial
Transesophageal echocardiography (TEE) is commonly used in operating room (cardiac surgery), as well as in other critical care settings. A recent meta-analysis including only three randomized studies demonstrated that the use of a videolaryngoscope for transesophageal echocardiography probe insertion in anesthetized patients undergoing open cardiac surgery was associated with a significant reduction in the number of attempts. insertion and complications rate, compared with blind insertion or a laryngoscope-assisted insertion.
ICU patients are usually intubated, with multiple complications, requiring high doses of catecholamines, and with frequent coagulation disorders. Many of these patients, during their stay in the ICU, require a transesophageal echocardiogram. On multiple occasions, due to the critical situation of the patients, due to edema, and coagulation alteration, the placement of the echocardiography probe can be difficult, leading to complications, such as gastric bleeding or lesions in the oropharyngeal mucosa.
Read more
To avoid complications during the insertion of the TEE tube, the investigators consider it necessary to introduce it in the fewest possible attempts.
The primary aim of the present study was to compare the success rate of TEE probe insertion at the first attempt betweenn the C-MAC videolaryngoscope assisted insertion and the blind insertion technique.
The secondary aim was to compared differences between the 2 groups in the incidence of complications ( oropharyngeal mucosal injury, hematoma, ….), overall success rate, the number of insertion attempts, and the duration of insertions.
Read the detailed description
One hundred intubated ICU adult patients that require transesophageal echocardiography insertion, will be randomized by means of a computer-generated randomization order into two groups: Conventional group (Group Blind), and videolaryngoscope group (group C-MAC).
Success rate of the selected technique (first attempt), overall success rate, number of attempts, complications, and duration of insertion for technique will be noted.
- Conditions
- Critical Illness
- Being tested
- Blind insertion technique, C-MAC videolaryngoscope insertion technique
- Keywords
- transesophageal, echocardiography, videolaryngoscope;
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blind insertion techniqueDevice
Transesophageal echocardiography probe will be inserted using a conventional blind insertion technique.
C-MAC videolaryngoscope insertion techniqueDevice
Transesophageal echocardiography probe will be inserted using a C-MAC videolaryngoscope insertion technique
| Study group | Role | What they receive |
|---|---|---|
| Conventional blind insertion technique. | Active comparator | Transesophageal echocardiography probe will be inserted using a conventional blind insertion technique. Receives: Device: Blind insertion technique |
| C-MAC videolaryngoscope insertion technique | Experimental | Transesophageal echocardiography probe will be inserted using a C-MAC videolaryngoscope insertion technique to advance into esophagus under direct vision. Receives: Device: C-MAC videolaryngoscope insertion technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the first attempt success rate (percentage)
To compare the difference in the first attempt (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 or three attempts)
Secondary outcomes (3)
Difference in the overall success rate (percentage)
To compare the difference overall success rate (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 or three attempts)
Difference in the incidence of complications (percentage)
To compare the difference in complications 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 or three attempts) and in the next 24 hours.
Difference in the duration of insertion
To compare the duration of different techniques for insertion of intransesophageal 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 or three attempts) and in the next 24 hour and in the next 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start19 Aug 2021
- Primary completion1 May 2023
- Study completion1 May 2023
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 Critical IllnessStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinico Universitario de Santiago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Taboada Muñiz, Hospital Clinico Universitario de Santiago
- Investigators
- Manuel Taboada, Principal investigator, University Clinical Hospital of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980976
- Sponsor's protocol ID
- CEIG 2020/375
- Acronym
- VIDLARECO
- Status last verified
- Sep 2023
- First submitted
- 21 Jul 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data types: Deidentified participant data How to access data: Requests must be sent to manutabo@yahoo.es When available: With publication Additional Information Who can access the data: Researchers whose proposed use of the data has been approved T ypes of analyses: For scientific purpose Mechanisms of data availability: With investigator support
Publications
Ishida T, Kiuchi C, Sekiguchi T, Tsujimoto T, Kawamata M. McGRATH MAC video laryngoscope for insertion of a transoesophageal echocardiography probe: A randomised controlled trial. Eur J Anaesthesiol. 2016 Apr;33(4):263-8. doi: 10.1097/EJA.0000000000000367.
PubMed 26575010Kavrut Ozturk N, Kavakli AS. Use of McGrath MAC Videolaryngoscope to Assist Transesophageal Echocardiography Probe Insertion in Intubated Patients. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):191-196. doi: 10.1053/j.jvca.2016.03.150. Epub 2016 Mar 31.
PubMed 27498268Kumamoto T, Tashima K, Hiraoka C, Ikuta Y, Yamamoto T. McGRATH MAC video laryngoscope assistance during transesophageal echocardiography may reduce the risk of complications: a manikin study. BMC Anesthesiol. 2021 Jan 11;21(1):14. doi: 10.1186/s12871-020-01231-3.
PubMed 33430768Kim MK, Park SW, Sim Y, Lee JW. Use of a McGrath Videolaryngoscope to assist transesophageal echocardiography probe insertion in anesthetized patients. J Cardiothorac Vasc Anesth. 2015 Apr;29(2):e16-7. doi: 10.1053/j.jvca.2014.09.007. Epub 2014 Dec 24. No abstract available.
PubMed 25543216Taboada M, Carinena A, Estany-Gestal A, Iglesias-Alvarez D, Veiras S, Martinez A, Eiras M, De Miguel M, Selas S, Martinez-Monzonis A, Pereira P, Bastos-Fernandez M, Gonzalez-Salvado V, Alvarez-Barrado M, Ferreiroa E, Caruezo V, Costa J, Naveira A, Otero P, Adrio B, Martinez-Cereijo JM, Fernandez A, Gonzalez-Juanatey JR, Alvarez J, Seoane-Pillado T. Videolaryngoscope versus conventional technique for insertion of a transesophageal echocardiography probe in intubated ICU patients (VIDLARECO trial): A randomized clinical trial. Anaesth Crit Care Pain Med. 2024 Apr;43(2):101346. doi: 10.1016/j.accpm.2024.101346. Epub 2024 Jan 24.
PubMed 38278357
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C-MAC Videolaryngoscope for Insertion of a Transesophageal Echocardiography Probe in ICU Patients. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04980976
- Acronym / sponsor ID
- VIDLARECO / CEIG 2020/375
- Conditions
- Critical Illness
- Keywords
- transesophageal, echocardiography, videolaryngoscope;
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospital Clinico Universitario de SantiagoUniversity, hospital or other
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 28 Jul 2021 (actual)
- 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.
Transesophageal echocardiography (TEE) is commonly used in operating room (cardiac surgery), as well as in other critical care settings. A recent meta-analysis including only three randomized studies demonstrated that the use of a videolaryngoscope for transesophageal echocardiography probe insertion in anesthetized patients undergoing open cardiac surgery was associated with a significant reduction in the number of attempts. insertion and complications rate, compared with blind insertion or a laryngoscope-assisted insertion.
ICU patients are usually intubated, with multiple complications, requiring high doses of catecholamines, and with frequent coagulation disorders. Many of these patients, during their stay in the ICU, require a transesophageal echocardiogram. On multiple occasions, due to the critical situation of the patients, due to edema, and coagulation alteration, the placement of the echocardiography probe can be difficult, leading to complications, such as gastric bleeding or lesions in the oropharyngeal mucosa.
To avoid complications during the insertion of the TEE tube, the investigators consider it necessary to introduce it in the fewest possible attempts.
The primary aim of the present study was to compare the success rate of TEE probe insertion at the first attempt betweenn the C-MAC videolaryngoscope assisted insertion and the blind insertion technique.
The secondary aim was to compared differences between the 2 groups in the incidence of complications ( oropharyngeal mucosal injury, hematoma, ….), overall success rate, the number of insertion attempts, and the duration of insertions.
Detailed description
One hundred intubated ICU adult patients that require transesophageal echocardiography insertion, will be randomized by means of a computer-generated randomization order into two groups: Conventional group (Group Blind), and videolaryngoscope group (group C-MAC).
Success rate of the selected technique (first attempt), overall success rate, number of attempts, complications, and duration of insertion for technique will be noted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional blind insertion technique. | Active comparator | Device: Blind insertion techniqueTransesophageal echocardiography probe will be inserted using a conventional blind insertion technique. |
| C-MAC videolaryngoscope insertion technique | Experimental | Device: C-MAC videolaryngoscope insertion techniqueTransesophageal echocardiography probe will be inserted using a C-MAC videolaryngoscope insertion technique to advance into esophagus under direct vision. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ICU intubated patients that require transesophageal echocardiography probe insertion
Key exclusion criteria (4 listed)
- patients younger than 18 years and older than 85 years
- oropharengeal infection
- esophageal injury and anatomic abnormalities
- Consent refusal for participating in the trial.
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 |
|---|---|---|
| Blind insertion techniqueTransesophageal echocardiography probe will be inserted using a conventional blind insertion technique. | Device | Conventional blind insertion technique. |
| C-MAC videolaryngoscope insertion techniqueTransesophageal echocardiography probe will be inserted using a C-MAC videolaryngoscope insertion technique | Device | C-MAC videolaryngoscope insertion technique |
Primary outcome
Difference in the first attempt success rate (percentage)
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 or three attempts)
To compare the difference in the first attempt (percentage) of different techniques for insertion of transesophageal echocardiography probe.
3 secondary outcomes
Difference in the overall success rate (percentage)
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 or three attempts)
Difference in the incidence of complications (percentage)
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 or three attempts) and in the next 24 hours.
Difference in the duration of insertion
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 or three attempts) and in the next 24 hour and in the next 24 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 21 Sep 2023.
- Background: PubMed 26575010Ishida T, Kiuchi C, Sekiguchi T, Tsujimoto T, Kawamata M. McGRATH MAC video laryngoscope for insertion of a transoesophageal echocardiography probe: A randomised controlled trial. Eur J Anaesthesiol. 2016 Apr;33(4):263-8. doi: 10.1097/EJA.0000000000000367.
- Background: PubMed 27498268Kavrut Ozturk N, Kavakli AS. Use of McGrath MAC Videolaryngoscope to Assist Transesophageal Echocardiography Probe Insertion in Intubated Patients. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):191-196. doi: 10.1053/j.jvca.2016.03.150. Epub 2016 Mar 31.
- Background: PubMed 33430768Kumamoto T, Tashima K, Hiraoka C, Ikuta Y, Yamamoto T. McGRATH MAC video laryngoscope assistance during transesophageal echocardiography may reduce the risk of complications: a manikin study. BMC Anesthesiol. 2021 Jan 11;21(1):14. doi: 10.1186/s12871-020-01231-3.
- Background: PubMed 25543216Kim MK, Park SW, Sim Y, Lee JW. Use of a McGrath Videolaryngoscope to assist transesophageal echocardiography probe insertion in anesthetized patients. J Cardiothorac Vasc Anesth. 2015 Apr;29(2):e16-7. doi: 10.1053/j.jvca.2014.09.007. Epub 2014 Dec 24. No abstract available.
- Derived from this study: PubMed 38278357Taboada M, Carinena A, Estany-Gestal A, Iglesias-Alvarez D, Veiras S, Martinez A, Eiras M, De Miguel M, Selas S, Martinez-Monzonis A, Pereira P, Bastos-Fernandez M, Gonzalez-Salvado V, Alvarez-Barrado M, Ferreiroa E, Caruezo V, Costa J, Naveira A, Otero P, Adrio B, Martinez-Cereijo JM, Fernandez A, Gonzalez-Juanatey JR, Alvarez J, Seoane-Pillado T. Videolaryngoscope versus conventional technique for insertion of a transesophageal echocardiography probe in intubated ICU patients (VIDLARECO trial): A randomized clinical trial. Anaesth Crit Care Pain Med. 2024 Apr;43(2):101346. doi: 10.1016/j.accpm.2024.101346. Epub 2024 Jan 24.
- Individual participant dataSharing planned: Yes. Data types: Deidentified participant data How to access data: Requests must be sent to manutabo@yahoo.es When available: With publication Additional Information Who can access the data: Researchers whose proposed use of the data has been approved T ypes of analyses: For scientific purpose Mechanisms of data availability: With investigator support
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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.
Manuel Taboada principal investigator
University Clinical Hospital of Santiago de Compostela
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blind insertion technique and C-MAC videolaryngoscope insertion technique in people with Critical Illness, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.
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 21 Sep 2023. 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 Spain. 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 success rate (percentage) (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 or three attempts)). 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 NCT04980976, 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 21 Sep 2023.