Orotracheal IntubationORIONNCT06622538
Orotracheal Intubation with the ORION Videolaryngoscope Versus the King Vision Videolaryngoscope in Adult Patients: ORION Trial
A study testing Orotracheal intubation in people with Orotracheal Intubation and Videolaryngoscopes (VL), run by Hospital General de México Dr. Eduardo Liceaga at 1 site in Mexico.
Trial summary
This study aims to compare the ORION video laryngoscope with the King Vision video laryngoscope for orotracheal intubation in patients without predictors of difficult airway scheduled for elective surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orotracheal Intubation, Videolaryngoscopes (VL), 3D Printing
- What is being tested?
- Orotracheal intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteMexico
- Study dates
- 1 Oct 2024to 31 Oct 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age scheduled for elective surgery requiring general anesthesia.
- Patients without predictors of difficult airway.
- Patients with ASA I-II classification.
- Patients with BMI less than 35 kg/mts2.
Who cannot join
- Pregnant women.
- Patients requiring emergency surgery.
- Patients with chronic obstructive pulmonary disease.
- Patients with a history of chronic ischemic heart disease.
- Patients with a history of asthma.
- Patients who have not signed the informed consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital General de Mèxico Dr. Eduardo Liceaga
Mexico City, Cuauhtemoc, 06920
About this study
Official title: Orotracheal Intubation with the ORION Videolaryngoscope Versus the King Vision Videolaryngoscope in Adult Patients Without Predictors of a Difficult Airway
This study aims to compare the ORION video laryngoscope with the King Vision video laryngoscope for orotracheal intubation in patients without predictors of difficult airway scheduled for elective surgery under general anesthesia.
Read the detailed description
The video laryngoscope, compared to direct laryngoscopy, provides better visualization of the laryngeal and glottic structures, a higher success rate for intubation on the first attempt, and a lower incidence of complications such as mucosal injury, dental injury, and esophageal intubations. Despite the advantages offered by video laryngoscopy, its use is not widespread in developing countries due to high costs. For this reason, the ORION video laryngoscope was developed as a low-cost, reusable device that can undergo high-level disinfection. It is designed using additive manufacturing and meets the standards for biocompatibility, rigidity, and resistance. Additionally, it has undergone preclinical testing in simulation models where anesthesiologists have approved its use in real clinical scenarios. In this study, patients scheduled for elective surgery under general anesthesia without predictors of difficult airway will be included and randomized to be intubated with either the ORION video laryngoscope or the King Vision video laryngoscope. The study will compare the success of intubation on the first attempt, the time taken for intubation, the level of visualization of the glottic structures, and the associated complications between the two video laryngoscopes.
- Being tested
- Orotracheal intubation
- Keywords
- 3d printing, Orotracheal intubation, videolaryngoscope, ORION, Additive Manufacturing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orotracheal intubationDevice
Patients who meet the inclusion criteria and sign the informed consent form will be intubated with the ORION or King Vision video laryngoscope according to randomisation.
| Study group | Role | What they receive |
|---|---|---|
| Videolaryngoscope King Vision | Active comparator | The King Vision video laryngoscope used in this study has a 45° angulation, with a disposable No. 3 blade and no channel for the orotracheal tube. Receives: Device: Orotracheal intubation |
| Videolaryngoscope ORION | Experimental | The ORION video laryngoscope is designed by additive manufacturing, has the same dimensions as a Macintosh No. 3 blade, with 45° angulation, is biocompatible and reusable when subjected to high-level disinfection with 2% Glutaraldehyde for 40 minutes. It has an endoscopic camera fully covered in the body of the videolaryngoscope of 8 mm diameter with 2 megapixels with a resolution of 1280x720, has a viewing angle of 70°, has 6 LEDS with adjustable intensity and the camera has an anti-fogging system and can be connected to any mobile device with Android operating system through a free application. (AN98 Version 2.2.0). It complies with ISO 7376:2020 standards for orotracheal intubation laryngoscopes because its blade withstands a stiffness of more than 60 Newtons and a resistance of more than 150 Newtons. Receives: Device: Orotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful first attempt
Measurement of orotracheal intubations obtained in the first attempt of videolaryngoscopy with the two videolaryngoscopes, successful orotracheal intubation will be corroborated by capnography. Measured in percentage (%).
Measured: After the endotracheal intubation completed
Secondary outcomes (7)
Intubation time
Time elapsed from the time the video laryngoscope blade crosses the dental arch until the orotracheal tube is inserted into the trachea, this time will be measured for each video laryngoscope. Measured in seconds (s).
Measured: After the endotracheal intubation completed
Laryngeal visualisation measured with the Cormack Lehane scale
Measurement of visualization of glottic structures using the Cormack Lehane scale in grade I, II, II and IV obtained with both video laryngoscopes. Measured in percentage (%).
Measured: After the endotracheal intubation completed
Laryngeal visualisation measured with the POGO scale
Measurement of the visualization of the glottic structures using the POGO (Percentage of Glottic Opening) scale from 0% to 100% obtained with both video laryngoscopes. Measured in percentage (%).
Measured: After the endotracheal intubation completed
Esophageal intubation
Measurement of the number of esophageal intubations obtained with both video laryngoscopes. Measured in percentage (%)
Measured: After the endotracheal intubation completed
Complications
Measurement of complications (mucosal, lip, oral, pharyngeal and laryngeal injury, total or partial fracture of a tooth and Hypoxemia) that occur with the use of the ORION and King Vision Videolaryngoscopes. Measured in percent (%)
Measured: After the endotracheal intubation completed
Number of video laryngoscopy attempts
Measurement of the number of video laryngoscopy attempts to successful intubation with both video laryngoscopes. Measurement in percentage (%)
Measured: After the endotracheal intubation completed
Intubation failure
Three videolaryngoscopies with duration of 120 seconds each without achieving orotracheal intubation. The number of intubation failures of both videolaryngoscopes will be measured in percentage (%).
Measured: After the endotracheal intubation completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Oct 2024
- Primary completion15 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orotracheal IntubationStudies 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
- Randomization in two groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General de México Dr. Eduardo Liceaga
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Juan Fernando Bautista Garcia, Hospital General de México Dr. Eduardo Liceaga
- Investigators
- Juan Fernando Bautista Garcia, Principal investigator, Hospital General de Mèxico Dr. Eduardo Liceaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622538
- Sponsor's protocol ID
- DI/24/310/03/26
- Acronym
- ORION
- Status last verified
- Feb 2025
- First submitted
- 24 Sep 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orotracheal Intubation with the ORION Videolaryngoscope Versus the King Vision Videolaryngoscope in Adult Patients Without Predictors of a Difficult Airway
- ClinicalTrials.gov ID
- NCT06622538
- Acronym / sponsor ID
- ORION / DI/24/310/03/26
- Keywords
- 3d printing, Orotracheal intubation, videolaryngoscope, ORION, Additive Manufacturing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital General de México Dr. Eduardo LiceagaOther government
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 2 Oct 2024 (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.
This study aims to compare the ORION video laryngoscope with the King Vision video laryngoscope for orotracheal intubation in patients without predictors of difficult airway scheduled for elective surgery under general anesthesia.
Detailed description
The video laryngoscope, compared to direct laryngoscopy, provides better visualization of the laryngeal and glottic structures, a higher success rate for intubation on the first attempt, and a lower incidence of complications such as mucosal injury, dental injury, and esophageal intubations. Despite the advantages offered by video laryngoscopy, its use is not widespread in developing countries due to high costs. For this reason, the ORION video laryngoscope was developed as a low-cost, reusable device that can undergo high-level disinfection. It is designed using additive manufacturing and meets the standards for biocompatibility, rigidity, and resistance. Additionally, it has undergone preclinical testing in simulation models where anesthesiologists have approved its use in real clinical scenarios. In this study, patients scheduled for elective surgery under general anesthesia without predictors of difficult airway will be included and randomized to be intubated with either the ORION video laryngoscope or the King Vision video laryngoscope. The study will compare the success of intubation on the first attempt, the time taken for intubation, the level of visualization of the glottic structures, and the associated complications between the two video laryngoscopes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomization in two groups
| Arm | Type | Receives |
|---|---|---|
| Videolaryngoscope King Vision | Active comparator | Device: Orotracheal intubationThe King Vision video laryngoscope used in this study has a 45° angulation, with a disposable No. 3 blade and no channel for the orotracheal tube. |
| Videolaryngoscope ORION | Experimental | Device: Orotracheal intubationThe ORION video laryngoscope is designed by additive manufacturing, has the same dimensions as a Macintosh No. 3 blade, with 45° angulation, is biocompatible and reusable when subjected to high-level disinfection with 2% Glutaraldehyde for 40 minutes. It has an endoscopic camera fully covered in the body of the videolaryngoscope of 8 mm diameter with 2 megapixels with a resolution of 1280x720, has a viewing angle of 70°, has 6 LEDS with adjustable intensity and the camera has an anti-fogging system and can be connected to any mobile device with Android operating system through a free application. (AN98 Version 2.2.0). It complies with ISO 7376:2020 standards for orotracheal intubation laryngoscopes because its blade withstands a stiffness of more than 60 Newtons and a resistance of more than 150 Newtons. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over 18 years of age scheduled for elective surgery requiring general anesthesia.
- Patients without predictors of difficult airway.
- Patients with ASA I-II classification.
- Patients with BMI less than 35 kg/mts2.
Key exclusion criteria (6 listed)
- Pregnant women.
- Patients requiring emergency surgery.
- Patients with chronic obstructive pulmonary disease.
- Patients with a history of chronic ischemic heart disease.
- Patients with a history of asthma.
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 |
|---|---|---|
| Orotracheal intubationPatients who meet the inclusion criteria and sign the informed consent form will be intubated with the ORION or King Vision video laryngoscope according to randomisation. | Device | Videolaryngoscope King Vision, Videolaryngoscope ORION |
Primary outcome
Successful first attempt
Time frame: After the endotracheal intubation completed
Measurement of orotracheal intubations obtained in the first attempt of videolaryngoscopy with the two videolaryngoscopes, successful orotracheal intubation will be corroborated by capnography. Measured in percentage (%).
7 secondary outcomes
Intubation time
Time frame: After the endotracheal intubation completed
Laryngeal visualisation measured with the Cormack Lehane scale
Time frame: After the endotracheal intubation completed
Laryngeal visualisation measured with the POGO scale
Time frame: After the endotracheal intubation completed
Esophageal intubation
Time frame: After the endotracheal intubation completed
Complications
Time frame: After the endotracheal intubation completed
Number of video laryngoscopy attempts
Time frame: After the endotracheal intubation completed
Intubation failure
Time frame: After the endotracheal intubation completed
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 25 Feb 2025.
- 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. This study is not recruiting at the moment.
Juan Fernando Bautista Garcia principal investigator
Hospital General de Mèxico Dr. Eduardo Liceaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orotracheal intubation in people with Orotracheal Intubation and Videolaryngoscopes (VL), run by Hospital General de México Dr. Eduardo Liceaga at 1 site in Mexico.
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 4 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: finished, as of the sponsor's last update on 25 Feb 2025. 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 Mexico. 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?
Successful first attempt (time frame: After the endotracheal intubation completed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2025.