Intubation ComplicationVIDEO-SURGNCT05850260
McGrath Video Laryngoscope for All Intubations in the Operating Room
An observational study of Intubation Complication, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.
Trial summary
Tracheal intubation is a very common procedure performed in the operating room. The usual intubation technique in the operating room is based on direct laryngoscopy, using a standard Macintosh laryngoscope. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intubation Complication
- What is being tested?
- Macintosh laryngoscope and Videolaryngoscope
- Type of treatment
- Medical device
- How many people
- 5,220 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2023to 30 Sep 2024
- How long will I take part?
- 1 Day
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients who need to be tracheal intubated for an elective o urgent surgical intervention from a period of 14 months by one of the 35 anesthesiologists assigned by the Anesthesiology Services of the 8 Hospitals.
Who may be able to join
- 18 years and older
- Patients who need to be tracheal intubated for a surgical intervention in the surgical area.
Who cannot join
- Patients who are intubated in a place other than the surgical area (Intensive Care, Emergency, Hospitalization floor) will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Providing a Personal McGrath Video Laryngoscope to Anesthesiologists for All Intubations in the Operating Room: a Multicentre Prospective Observational, Before-after Study
Tracheal intubation is a very common procedure performed in the operating room. The usual intubation technique in the operating room is based on direct laryngoscopy, using a standard Macintosh laryngoscope. Although in most patients there are no complications during intubation, more than 90% of difficult tracheal intubations in the operate room are unpredictable, and several authors, recommend the universal use of the videolaryngoscope for all intubations, using as the first intubation option regardless of whether the patient has predictors of a difficult airway or no.The authors do not know whether providing a own videolaryngoscope to each anesthesiologist to use as the first option for intubation in all patients who need it in the operating room improves the percentage of patients with easy intubation and decrease the incidence of complications.
Read the detailed description
Tracheal intubation is a very common procedure performed in the operating room. The usual intubation technique in the operating room is based on direct laryngoscopy, using a standard Macintosh laryngoscope. Although in most patients there are no complications during intubation, more than 90% of difficult tracheal intubations in the operate room are unpredictable, and several authors, recommend the universal use of the videolaryngoscope for all intubations, using as the first intubation option regardless of whether the patient has predictors of a difficult airway or no. The authors do not know whether providing a personal videolaryngoscope to each anesthesiologist to use as the first option for intubation in all patients who need it in the operating room improves the percentage of patients with easy intubation and decrease the incidence of complications.
The VIDEOLAR-SURGERY trial is a prospective, observational, open-label, multicenter study, with before-after analysis. Consecutive patients requiring tracheal intubation for an elective o urgent surgical intervention from a period of 14 months by one of the 35 researcher's anesthesiologists assigned will be recruited. In the pre-implementation period (6 months), the 35 anesthesiologists will perform all tracheal intubations using the standard Macintosh direct laryngoscope as a first intubation option. During the implementation period (2 months), a personal McGrath videolaryngoscope will be provided to each anesthesiologist to train in its use. During the post-implementation period (6 months), the 35 anesthesiologists will perform all tracheal intubations using their personal McGrath Mac videolaryngoscope as a first intubation option. The main objective is to evaluate whether the use of a own McGrath videolaryngoscope by anesthesiologists, as the first intubation option, improves the percentage of patients with easy intubation compared with the standard Macintosh laryngoscope. Secondary objectives are to compare incidence of first-attempt intubation, laryngoscopic vision, need of adjuvant airway devices, difficulty, and complications.
- Conditions
- Intubation Complication
- Being tested
- Macintosh laryngoscope, Videolaryngoscope
- Keywords
- diificult intubation, videolaryngoscope, airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macintosh laryngoscopeDevice
During the pre-implementation period (6 months), the 35 assigned attending anesthetists will perform all tracheal intubations in the operation room according to the standard of care using the standard Macintosh direct laryngoscope as a first intubation option
VideolaryngoscopeDevice
During the post-implementation period (6 months), the 35 assigned attending anesthetists will perform all tracheal intubations using their personal McGrath Mac videolaryngoscope as a first intubation option.
| Study group | Role | What they receive |
|---|---|---|
| Macintosh laryngoscope | During the pre-implementation period (6 months), the 35 assigned attending anesthetists will perform all tracheal intubations in the operation room according to the standard of care using the standard Macintosh direct laryngoscope as a first intubation option Receives: Device: Macintosh laryngoscope | |
| McGrath Mac videolaryngoscope | During the post-implementation period (6 months), the 35 assigned attending anesthetists will perform all tracheal intubations using their personal McGrath Mac videolaryngoscope as a first intubation option Receives: Device: Videolaryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
"easy intubation"
To compare "easy intubation" in the two study periods. "Easy intubation" defined as intubation at the first attempt, modified Cormack-Lehane grades of I or IIa and absence of need of adjuvant airway devices for intubation. (percentage)
Measured: during intubation
Secondary outcomes (8)
Intubations at the first attempt
To compare difference in the incidence of intubations at the first attempt in the two periods studied. (percentage)
Measured: during intubation
Number of intubations attempts
To compare number of intubations attempts in the two periods studied
Measured: during intubation
Modified Cormack-Lehane grade of glottic view
To compare Modified Cormack-Lehane grade of glottic view in the two periods studied Modified Cormack-Lehane grade of glottic view:I: full view of the glottis 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
Measured: during intubation
Need of adjuvant airway devices for intubation
To compare need of adjuvant airway devices for intubation in the two periods studied airway devices for intubation: bougie, videolaryngoscope, others)
Measured: during intubation
Operator-assessed subjective difficulty
To compare degree of subjective difficulty experienced by the operator in the two periods studied.
Subjective difficulty of intubation by means of a special analogue numerical scale from 0 to 10, where 0=no subjective difficulty and 10=maximal subjective difficulty
Measured: during intubation
Complications during intubation
To compare percentage of complications associated with the intubation in the two periods studied
Measured: Participants will be followed from the beginning of the intervention to 30 minutes after the intervention
Overall success rate intubation
To compare the difference overall success rate intubation (percentage) with the first device used in each period
Measured: During intubation
Need to change the device for intubation
To compare the need to change the device for intubation in the two periods studied
Measured: During intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start1 Jun 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
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 Intubation ComplicationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,220 participants (actual)
- Target duration
- 1 Day
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 Muñiz, M.D., Ph.D., Principal investigator, University Clinical Hospital of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850260
- Sponsor's protocol ID
- VIDEOLAR-SURGERY
- Acronym
- VIDEO-SURG
- Status last verified
- Jul 2024
- First submitted
- 18 Apr 2023
- Last updated
- 22 Oct 2024
- 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 Types of analyses: For scientific purpose Mechanisms of data availability: With investigator support
Publications
Hansel J, Rogers AM, Lewis SR, Cook TM, Smith AF. Videolaryngoscopy versus direct laryngoscopy for adults undergoing tracheal intubation: a Cochrane systematic review and meta-analysis update. Br J Anaesth. 2022 Oct;129(4):612-623. doi: 10.1016/j.bja.2022.05.027. Epub 2022 Jul 9.
PubMed 35820934De Jong A, Sfara T, Pouzeratte Y, Pensier J, Rolle A, Chanques G, Jaber S. Videolaryngoscopy as a first-intention technique for tracheal intubation in unselected surgical patients: a before and after observational study. Br J Anaesth. 2022 Oct;129(4):624-634. doi: 10.1016/j.bja.2022.05.030. Epub 2022 Jul 8.
PubMed 35811139Cook TM, Boniface NJ, Seller C, Hughes J, Damen C, MacDonald L, Kelly FE. Universal videolaryngoscopy: a structured approach to conversion to videolaryngoscopy for all intubations in an anaesthetic and intensive care department. Br J Anaesth. 2018 Jan;120(1):173-180. doi: 10.1016/j.bja.2017.11.014. Epub 2017 Nov 21.
PubMed 29397126Cooper RM. Implementing universal videolaryngoscopy: how to do it and what to expect. Br J Anaesth. 2018 Jan;120(1):13-15. doi: 10.1016/j.bja.2017.11.017. Epub 2017 Nov 21. No abstract available.
PubMed 29397120Taboada M, Estany-Gestal A, Rama-Maceiras P, Orallo MA, Bermudez M, Barreiro C, Gomez L, Amor M, Otero F, Fernandez J, Molins N, Amate JJ, Bascuas B, Rey R, Alonso MC, Castro MJ, Sarmiento A, Dos Santos L, Nieto C, Paredes S, Velasco A, Taboada C, Martin L, Campana D, Mosquera E, Novoa C, Varela S, da Silva L, Dominguez E, Bedoya A, Gomez AI, Estevez M, Martinez P, Sotojove R, Naveiro A, Diaz C, Ruido R, Miron P, Gonzalez M, Francisco C, Regueira J, Peiteado M, Eiras M, Paz E. Impact of universal use of the McGrath videolaryngoscope as the first option for all intubations in the operating room: The multicentre prospective before-after VIDEOLAR-SURGERY study protocol. Rev Esp Anestesiol Reanim (Engl Ed). 2025 Jan;72(1):101649. doi: 10.1016/j.redare.2024.101649. Epub 2024 Nov 12.
PubMed 39542091
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Providing a Personal McGrath Video Laryngoscope to Anesthesiologists for All Intubations in the Operating Room: a Multicentre Prospective Observational, Before-after Study
- ClinicalTrials.gov ID
- NCT05850260
- Acronym / sponsor ID
- VIDEO-SURG / VIDEOLAR-SURGERY
- Conditions
- Intubation Complication
- Keywords
- diificult intubation, videolaryngoscope, airway
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,220 participants (actual)
- Lead sponsor
- Hospital Clinico Universitario de SantiagoUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 9 May 2023 (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.
Tracheal intubation is a very common procedure performed in the operating room. The usual intubation technique in the operating room is based on direct laryngoscopy, using a standard Macintosh laryngoscope. Although in most patients there are no complications during intubation, more than 90% of difficult tracheal intubations in the operate room are unpredictable, and several authors, recommend the universal use of the videolaryngoscope for all intubations, using as the first intubation option regardless of whether the patient has predictors of a difficult airway or no.The authors do not know whether providing a own videolaryngoscope to each anesthesiologist to use as the first option for intubation in all patients who need it in the operating room improves the percentage of patients with easy intubation and decrease the incidence of complications.
Detailed description
Tracheal intubation is a very common procedure performed in the operating room. The usual intubation technique in the operating room is based on direct laryngoscopy, using a standard Macintosh laryngoscope. Although in most patients there are no complications during intubation, more than 90% of difficult tracheal intubations in the operate room are unpredictable, and several authors, recommend the universal use of the videolaryngoscope for all intubations, using as the first intubation option regardless of whether the patient has predictors of a difficult airway or no. The authors do not know whether providing a personal videolaryngoscope to each anesthesiologist to use as the first option for intubation in all patients who need it in the operating room improves the percentage of patients with easy intubation and decrease the incidence of complications.
The VIDEOLAR-SURGERY trial is a prospective, observational, open-label, multicenter study, with before-after analysis. Consecutive patients requiring tracheal intubation for an elective o urgent surgical intervention from a period of 14 months by one of the 35 researcher's anesthesiologists assigned will be recruited. In the pre-implementation period (6 months), the 35 anesthesiologists will perform all tracheal intubations using the standard Macintosh direct laryngoscope as a first intubation option. During the implementation period (2 months), a personal McGrath videolaryngoscope will be provided to each anesthesiologist to train in its use. During the post-implementation period (6 months), the 35 anesthesiologists will perform all tracheal intubations using their personal McGrath Mac videolaryngoscope as a first intubation option. The main objective is to evaluate whether the use of a own McGrath videolaryngoscope by anesthesiologists, as the first intubation option, improves the percentage of patients with easy intubation compared with the standard Macintosh laryngoscope. Secondary objectives are to compare incidence of first-attempt intubation, laryngoscopic vision, need of adjuvant airway devices, difficulty, and complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Macintosh laryngoscope | – | Device: Macintosh laryngoscopeDuring the pre-implementation period (6 months), the 35 assigned attending anesthetists will perform all tracheal intubations in the operation room according to the standard of care using the standard Macintosh direct laryngoscope as a first intubation option |
| McGrath Mac videolaryngoscope | – | Device: VideolaryngoscopeDuring the post-implementation period (6 months), the 35 assigned attending anesthetists will perform all tracheal intubations using their personal McGrath Mac videolaryngoscope as a first intubation option |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients who need to be tracheal intubated for an elective o urgent surgical intervention from a period of 14 months by one of the 35 anesthesiologists assigned by the Anesthesiology Services of the 8 Hospitals.
Key inclusion criteria (2 listed)
- 18 years and older
- Patients who need to be tracheal intubated for a surgical intervention in the surgical area.
Key exclusion criteria (1 listed)
- Patients who are intubated in a place other than the surgical area (Intensive Care, Emergency, Hospitalization floor) will not be included.
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 |
|---|---|---|
| Macintosh laryngoscopeDuring the pre-implementation period (6 months), the 35 assigned attending anesthetists will perform all tracheal intubations in the operation room according to the standard of care using the standard Macintosh direct laryngoscope as a first intubation option | Device | Macintosh laryngoscope |
| VideolaryngoscopeDuring the post-implementation period (6 months), the 35 assigned attending anesthetists will perform all tracheal intubations using their personal McGrath Mac videolaryngoscope as a first intubation option. | Device | McGrath Mac videolaryngoscope |
Primary outcome
"easy intubation"
Time frame: during intubation
To compare "easy intubation" in the two study periods. "Easy intubation" defined as intubation at the first attempt, modified Cormack-Lehane grades of I or IIa and absence of need of adjuvant airway devices for intubation. (percentage)
8 secondary outcomes
Intubations at the first attempt
Time frame: during intubation
Number of intubations attempts
Time frame: during intubation
Modified Cormack-Lehane grade of glottic view
Time frame: during intubation
Need of adjuvant airway devices for intubation
Time frame: during intubation
Operator-assessed subjective difficulty
Time frame: during intubation
Complications during intubation
Time frame: Participants will be followed from the beginning of the intervention to 30 minutes after the intervention
Overall success rate intubation
Time frame: During intubation
Need to change the device for intubation
Time frame: During intubation
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 22 Oct 2024.
- Background: PubMed 35820934Hansel J, Rogers AM, Lewis SR, Cook TM, Smith AF. Videolaryngoscopy versus direct laryngoscopy for adults undergoing tracheal intubation: a Cochrane systematic review and meta-analysis update. Br J Anaesth. 2022 Oct;129(4):612-623. doi: 10.1016/j.bja.2022.05.027. Epub 2022 Jul 9.
- Background: PubMed 35811139De Jong A, Sfara T, Pouzeratte Y, Pensier J, Rolle A, Chanques G, Jaber S. Videolaryngoscopy as a first-intention technique for tracheal intubation in unselected surgical patients: a before and after observational study. Br J Anaesth. 2022 Oct;129(4):624-634. doi: 10.1016/j.bja.2022.05.030. Epub 2022 Jul 8.
- Background: PubMed 29397126Cook TM, Boniface NJ, Seller C, Hughes J, Damen C, MacDonald L, Kelly FE. Universal videolaryngoscopy: a structured approach to conversion to videolaryngoscopy for all intubations in an anaesthetic and intensive care department. Br J Anaesth. 2018 Jan;120(1):173-180. doi: 10.1016/j.bja.2017.11.014. Epub 2017 Nov 21.
- Background: PubMed 29397120Cooper RM. Implementing universal videolaryngoscopy: how to do it and what to expect. Br J Anaesth. 2018 Jan;120(1):13-15. doi: 10.1016/j.bja.2017.11.017. Epub 2017 Nov 21. No abstract available.
- Derived from this study: PubMed 39542091Taboada M, Estany-Gestal A, Rama-Maceiras P, Orallo MA, Bermudez M, Barreiro C, Gomez L, Amor M, Otero F, Fernandez J, Molins N, Amate JJ, Bascuas B, Rey R, Alonso MC, Castro MJ, Sarmiento A, Dos Santos L, Nieto C, Paredes S, Velasco A, Taboada C, Martin L, Campana D, Mosquera E, Novoa C, Varela S, da Silva L, Dominguez E, Bedoya A, Gomez AI, Estevez M, Martinez P, Sotojove R, Naveiro A, Diaz C, Ruido R, Miron P, Gonzalez M, Francisco C, Regueira J, Peiteado M, Eiras M, Paz E. Impact of universal use of the McGrath videolaryngoscope as the first option for all intubations in the operating room: The multicentre prospective before-after VIDEOLAR-SURGERY study protocol. Rev Esp Anestesiol Reanim (Engl Ed). 2025 Jan;72(1):101649. doi: 10.1016/j.redare.2024.101649. Epub 2024 Nov 12.
- 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 Types 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 Muñiz, M.D., Ph.D. 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?
An observational study of Intubation Complication, 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 2 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 22 Oct 2024. 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?
"easy intubation" (time frame: during intubation). 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 NCT05850260, 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 22 Oct 2024.