Intubated PatientsVIDLARTRAQNCT05416489
C-MAC Videolaryngoscopy Versus Direct Laryngoscopy for Percutaneous Tracheostomy
A study testing C-MAC videolayngoscopy technique and Laryngoscopy technique in people with Intubated Patients and Percutaneous Tracheostomy, run by Hospital Clinico Universitario de Santiago at 2 sites in Spain.
Trial summary
When preparing an ICU patient for percutaneous dilational tracheostomy, correct positioning of the endotracheal tube is important. During the procedure, it is possible to puncture the cuff. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Intubated Patients, Percutaneous Tracheostomy
- What is being tested?
- C-MAC videolayngoscopy technique and Laryngoscopy technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jan 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 a percutaneous dilational tracheostomy for clinical reasons (prolonged mechanical ventilation, airway protection or weaning failure).
Who cannot join
- Patients younger than 18 years and older than 85 years
- Trachea and neck abnormalities.
- Soft tissue infection in the neck.
- History of neck surgery.
- Coagulation disorders or changes in coagulation parameters (platelet count < 50.000 mm3, an activated partial thromboplastin time 1.5-fold longer than the control value, and international normalized ratio > 1.5).
- Consent refusal for participating in the trial.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
University Clinical Hospital of Santiago de Compostela
Santiago de Compostela, A Coruña, 15866
Manuel Taboada Muñiz, Ph.D., +34678195618, manutabo@yahoo.es
María Teresa Cabaleiro Ocampo, +34 981 951 628
- Recruiting
University Clinical Hospital of Santiago de Compostela
Santiago de Compostela, A Coruña, 15866
Manuel Taboada, Ph.D., manutabo@yahoo.es
About this study
Official title: Videolaryngoscopy Versus Direct Laryngoscopy for Positioning the Tracheal Tube During Percutaneous Tracheostomy: A Randomized Controlled Trial (VIDLARTRAQUEO).
When preparing an ICU patient for percutaneous dilational tracheostomy, correct positioning of the endotracheal tube is important. During the procedure, it is possible to puncture the cuff. Tracheal tube cuff puncture can lead to failure of ventilation, loss of positive end-expiratory pressure, and possible aspiration of gastric contents blood or secretions. To minimize the risk, in our ICU, we withdraw the endotracheal tube under direct laryngoscopic vision until the cuff is visible at the vocal cords. This maneuver would also facilitate insertion of the Seldinger needle and insertion of the tracheostomy tube below the endotracheal tube. However, this maneuver to remove the endotracheal tube under direct laryngoscopy can sometimes be difficult. ICU patients present frecuently difficult laryngoscopic vision due to airway edema or secretions. In ICU, the videolaryngopy has been shown to be superior to direct laryngoscopy in visualization the upper airway, allowing better laryngoscopic vision.
Read the detailed description
The investigators aim to compare C-MAC videolaryngoscopy versus conventional direct laryngoscopy for positioning the tracheal tube to facilitate insertion of the Seldinger needle and the tracheostomy tube below the endotracheal tube during percutaneous tracheostomy.
- Conditions
- Intubated Patients, Percutaneous Tracheostomy
- Being tested
- C-MAC videolayngoscopy technique, Laryngoscopy technique
- Keywords
- Tracheostomy, Critical care, Videolaryngoscopy, Direct laryngoscopy, Airway management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-MAC videolayngoscopy techniqueDevice
Endotracheal tube will be removed before percutaneous tracheostomy using a C-MAC videolaryngoscopy.
Laryngoscopy techniqueDevice
Endotracheal tube will be removed before percutaneous tracheostomy using a laryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| Traditional direct laryngoscopy technique | Active comparator | Endotracheal tube will be removed before percutaneous tracheostomy using a traditional direct laryngoscopy technique. Receives: Device: Laryngoscopy technique |
| C-MAC videolaryngoscope technique | Active comparator | Endotracheal tube will be removed before percutaneous tracheostomy using a C-MAC videolaryngoscope technique. Receives: Device: C-MAC videolayngoscopy technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introduction of the Seldinger needle below the endotracheal tube
Percentage of patients in whom the introduction of the Seldinger needle is below the tip of the endotracheal tube
Measured: during the procedure
Secondary outcomes (6)
Puncture of the cuff of the endotracheal tube with the Seldinger needle
Percentage of patients suffering puncture the cuff of the endotracheal tube with the Seldinger needle
Measured: during the procedure
patients who need to remove the endotracheal tube to introduce the percutaneous tracheostomy cannula
Percentage of patients who need to remove the endotracheal tube to introduce the percutaneous tracheostomy cannula
Measured: during the procedure
Laryngoscopy vision using de Modified Cormack-Lehane grade of glottic view
Differences in laryngoscopy vision using de modified Cormack-Lehane grade of glottic view
Modified Cormack-Lehane grade of glottic view:
I: full view of the glottis (better outcome) IIa: partial view of the glottis IIb: arytenoid or posterior part of the vocal cords just visible III: only epiglottis visible IV: neither glottis nor epiglottis visible (worse outcome)
Measured: during the procedure
Difficulty of removing the endotracheal tube
Differences in the difficulty of removing the endotracheal tube due to poor visualization, secretions....
Operator-assessed subjective difficulty of removing the endotracheal tube: No difficulty, mild difficulty, moderate difficulty, severe difficulty.
Measured: during the procedure
Difficulty of performing percutaneous tracheotomy
Differences in the difficulty of performing percutaneous tracheotomy Operator-assessed subjective difficulty of performing percutaneous tracheotomy: No difficulty, mild difficulty, moderate difficulty, severe difficulty.
Measured: during the procedure
Complications
Percentage of complications
Measured: during the ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start1 Jan 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
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 Intubated PatientsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416489
- Sponsor's protocol ID
- VIDLARTRAQUEO
- Acronym
- VIDLARTRAQ
- Status last verified
- Sep 2025
- First submitted
- 24 Feb 2022
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Johnson-Obaseki S, Veljkovic A, Javidnia H. Complication rates of open surgical versus percutaneous tracheostomy in critically ill patients. Laryngoscope. 2016 Nov;126(11):2459-2467. doi: 10.1002/lary.26019. Epub 2016 Apr 14.
PubMed 27075530
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Videolaryngoscopy Versus Direct Laryngoscopy for Positioning the Tracheal Tube During Percutaneous Tracheostomy: A Randomized Controlled Trial (VIDLARTRAQUEO).
- ClinicalTrials.gov ID
- NCT05416489
- Acronym / sponsor ID
- VIDLARTRAQ / VIDLARTRAQUEO
- Conditions
- Intubated Patients, Percutaneous Tracheostomy
- Keywords
- Tracheostomy, Critical care, Videolaryngoscopy, Direct laryngoscopy, Airway management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospital Clinico Universitario de SantiagoUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 13 Jun 2022 (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.
When preparing an ICU patient for percutaneous dilational tracheostomy, correct positioning of the endotracheal tube is important. During the procedure, it is possible to puncture the cuff. Tracheal tube cuff puncture can lead to failure of ventilation, loss of positive end-expiratory pressure, and possible aspiration of gastric contents blood or secretions. To minimize the risk, in our ICU, we withdraw the endotracheal tube under direct laryngoscopic vision until the cuff is visible at the vocal cords. This maneuver would also facilitate insertion of the Seldinger needle and insertion of the tracheostomy tube below the endotracheal tube. However, this maneuver to remove the endotracheal tube under direct laryngoscopy can sometimes be difficult. ICU patients present frecuently difficult laryngoscopic vision due to airway edema or secretions. In ICU, the videolaryngopy has been shown to be superior to direct laryngoscopy in visualization the upper airway, allowing better laryngoscopic vision.
Detailed description
The investigators aim to compare C-MAC videolaryngoscopy versus conventional direct laryngoscopy for positioning the tracheal tube to facilitate insertion of the Seldinger needle and the tracheostomy tube below the endotracheal tube during percutaneous tracheostomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled.
| Arm | Type | Receives |
|---|---|---|
| Traditional direct laryngoscopy technique | Active comparator | Device: Laryngoscopy techniqueEndotracheal tube will be removed before percutaneous tracheostomy using a traditional direct laryngoscopy technique. |
| C-MAC videolaryngoscope technique | Active comparator | Device: C-MAC videolayngoscopy techniqueEndotracheal tube will be removed before percutaneous tracheostomy using a C-MAC videolaryngoscope technique. |
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 a percutaneous dilational tracheostomy for clinical reasons (prolonged mechanical ventilation, airway protection or weaning failure).
Key exclusion criteria (6 listed)
- Patients younger than 18 years and older than 85 years
- Trachea and neck abnormalities.
- Soft tissue infection in the neck.
- History of neck surgery.
- Coagulation disorders or changes in coagulation parameters (platelet count < 50.000 mm3, an activated partial thromboplastin time 1.5-fold longer than the control value, and international normalized ratio > 1.5).
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 |
|---|---|---|
| C-MAC videolayngoscopy techniqueEndotracheal tube will be removed before percutaneous tracheostomy using a C-MAC videolaryngoscopy. | Device | C-MAC videolaryngoscope technique |
| Laryngoscopy techniqueEndotracheal tube will be removed before percutaneous tracheostomy using a laryngoscopy | Device | Traditional direct laryngoscopy technique |
Primary outcome
Introduction of the Seldinger needle below the endotracheal tube
Time frame: during the procedure
Percentage of patients in whom the introduction of the Seldinger needle is below the tip of the endotracheal tube
6 secondary outcomes
Puncture of the cuff of the endotracheal tube with the Seldinger needle
Time frame: during the procedure
patients who need to remove the endotracheal tube to introduce the percutaneous tracheostomy cannula
Time frame: during the procedure
Laryngoscopy vision using de Modified Cormack-Lehane grade of glottic view
Time frame: during the procedure
Difficulty of removing the endotracheal tube
Time frame: during the procedure
Difficulty of performing percutaneous tracheotomy
Time frame: during the procedure
Complications
Time frame: during the ICU stay
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Background: PubMed 27075530Johnson-Obaseki S, Veljkovic A, Javidnia H. Complication rates of open surgical versus percutaneous tracheostomy in critically ill patients. Laryngoscope. 2016 Nov;126(11):2459-2467. doi: 10.1002/lary.26019. Epub 2016 Apr 14.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-MAC videolayngoscopy technique and Laryngoscopy technique in people with Intubated Patients and Percutaneous Tracheostomy, run by Hospital Clinico Universitario de Santiago at 2 sites 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 6 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: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manuel Taboada, Ph.D. (0034981950674, manutabo@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Introduction of the Seldinger needle below the endotracheal tube (time frame: during the procedure). 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 NCT05416489, 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 15 Sep 2025.