Intubation; Difficult or FailedNCT06676462
Non-inferiority Trial Comparing visionPRO to Glidescope Video Laryngoscopes
A study testing Video laryngoscopy with visionPRO and Video laryngoscopy with Glidescope in people with Intubation; Difficult or Failed and Intubation Complication, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial summary
Indirect video laryngoscope tracheal intubation with the GlideScope (Verathon Inc., Bothell, USA) has become a well-established technique in emergency and clinical anaesthesia, offering first-pass intubation success rates comparable to those achieved with direct laryngoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation; Difficult or Failed, Intubation Complication, Video Laryngoscopy
- What is being tested?
- Video laryngoscopy with visionPRO and Video laryngoscopy with Glidescope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Jan 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having elective surgery with general anesthesia
- At least 18 years of age
- requiring mechanical ventilation via an oral endotracheal tube
Who cannot join
- More than one predictor of an anticipated difficult airway (eg, body mass index (BMI) >40 kg/m2, unanticipated difficult airway in the medical history (eg, Cormack \& Lehane (C\&L) ≥III), reduction of the atlanto-occipital joint extension <35°, reduced thyromental distance <6 cm or Mallampati class ≥III)
- Age <18 years
- ASA class IV-VI
- Pregnant or breastfeeding
- Unable to provide informed written consent or under guardianship
- Urgent surgical intervention
- At high risk for aspiration
- Patients undergoing any neck and throat surgery.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pilot Study Comparing the HEINE visionPRO HyMac 3 and the GlideScope Hyperangulated S3 Laryngoscope Blade on Time to Intubation
Indirect video laryngoscope tracheal intubation with the GlideScope (Verathon Inc., Bothell, USA) has become a well-established technique in emergency and clinical anaesthesia, offering first-pass intubation success rates comparable to those achieved with direct laryngoscopy. Different video laryngoscopes vary significantly in design, including blade shape, mobility, and camera operation, which can affect patient outcomes. Two video laryngoscopes with hyperangulated blades include the GlideScope (Verathon Inc., Bothell, USA) and the visionPRO (HEINE® Optotechnick, Gilching, Germany). The Glidescope comprises an external monitor connected to a medical-grade plastic handle which is compatible with reusable and disposable blades. The newer visionPro comprises a reusable anodized aluminum integrated monitor that is attached to the camera/handle which is compatible with disposable blades. The hyperangulated blade of the VisionPro is a unique combination of previously designed laryngoscope blades meant to increase performance. The introduction of this new hyperangulated blade design in the VisionPro raises the need to compare its performance against the established GlideScope.
The aim of this pilot study is to generate initial data to evaluate whether the use of the visionPRO (HEINE® Optotechnick, Gilching, Germany) provides a non-inferior first-pass success rate compared with the GlideScope (Verathon Inc., Bothell, USA) in surgical patients with an expected normal airway undergoing general anaesthesia The investigators hypothesize that tracheal intubation using the HEINE visionPRO will achieve a similar frequency of failed intubation and airway complications. This study plans to recruit 100 patients.
Read the detailed description
This trial is a single-centre, pilot, patient-blinded, randomized controlled non-inferiority trial.
Patients who decide to participate in this study will have their surgery and follow up care proceed according to standard of care. Video laryngoscopy is standard of care for this patient population at LHSC. Once eligibility is confirmed and informed, written consent has been obtained, participants be randomized to one of two study groups:
- Laryngoscopy performed using the Glidescope device (Verathon Inc., Bothell, USA)
- Laryngoscopy performed using the visionPRO device (HEINE® Optotechnick, Gilching, Germany)
Surgery, anesthetic management, and intubation protocol will proceed according to standard of care.
(A) All patients are observed for ECG, oxygen saturation (SpO2), and non-invasive blood pressure. Pre-oxygenation is carried out by the provider based on patient characteristics and standard clinical procedures (EtO2 > 80%).
(B) After adequate pre-oxygenation, anaesthesia is initiated using a combination of fentanyl (0.1 - 0.15 µg.kg-1) / sufentanil (0.2 - 0.5 µg.kg-1), and propofol (2 - 3 mg.kg-1), with the choice of drugs and dosages tailored to the specific needs of the patient. Maintenance is achieved either through propofol infusion (TIVA) or inhaled anaesthetics. The selection of a neuromuscular blocking agent is based on the surgery's duration, the need for perioperative neurological monitoring, and the absence of allergies and organ failures. The agents and their dosages used are:
- Rocuronium (0.5 - 1.2 mg.kg-1); and
- Succinylcholine (1 - 2 mg.kg-1).
The train-of-four (TOF) method is employed by the study nurse for continuous quantitative monitoring of neuromuscular transmission. Complete muscle relaxation is confirmed by the absence of tactile and measured twitches in response to maximal TOF stimulation of the ulnar nerve at the adductor pollicis. Study personnel were instructed on the importance of achieving adequate neuromuscular blockade.
(C) The laryngoscopy attempt starts with a TOF count of 0/4, using the device specified by randomization:
- visionPRO (HEINE® Optotechnick, Gilching, Germany) or
- GlideScope (Verathon Inc., Bothell, USA)
The provider aims to achieve the clearest view of the laryngeal structures. External laryngeal manipulations (ELM) may be employed to enhance the view of the glottis, aiming for a Cormack and Lehane grade I or II. The endotracheal tube size and blade size are chosen according to the hospital's standard operating procedures (blade size: #3 for average patients, #4 for taller patients; standard ET sizes: 7.0-7.5 ID for female patients and 7.5-8.0 ID for male patients). The method of glottic visualization and the size of the ET and blade are documented in the case report form (CRF).
(D) An intubation attempt is defined as the insertion and removal of the laryngoscope blade from the mouth, regardless of ET insertion success. A laryngoscopy attempt is considered successful if the tracheal tube is placed with a single blade insertion within 120 seconds and without manipulation of the laryngoscope by another provider. The following times periods until final ET placement are measured by a study nurse via a timer:
- "Time to intubation": duration from the opening of the patient's mouth to the passage of the ET through the vocal cords.
- "Time to view": the time from device insertion to visualization of the glottis;
- "Time to ventilation": the time from device insertion into the mouth until confirmation of the first CO2 wave on the anaesthesia respirator.
If the first attempt fails, the provider makes a second attempt with the same device, with mask ventilation recommended between attempts. A maximum of two laryngoscopy attempts are allowed. After two attempts the clinician switches to a preferred technique and records the direct and/or screen view. If this preferred technique fails after two attempts, the clinician proceeds with a preferred rescue technique. The study protocol recommends this limit of two intubation attempts and alternative technique selection in line with clinical standards. If ELM techniques, such as BURP (specific pressure applied to the cricoid cartilage), are needed during laryngoscopy, they are documented in the CRF. Throughout the induction of anaesthesia, a study nurse not involved in patient care records the study parameters.
24 hours following surgery, the patient will be assessed for presence and severity of sore throat rated on a scale of 0-3 (0 meaning no sore throat and 3 meaning severe sore throat), hoarseness rated on a scale of 0-3 (0 meaning no complaint and 3 meaning severe hoarseness), and cough rated on a scale of 0-3 (0 meaning no cough and 3 meaning severe cough).
- Conditions
- Intubation; Difficult or Failed, Intubation Complication, Video Laryngoscopy, Airway Management
- Being tested
- Video laryngoscopy with visionPRO, Video laryngoscopy with Glidescope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video laryngoscopy with visionPRODevice
Video laryngoscopy to be performed using the visionPRO (HEINE® Optotechnick, Gilching, Germany) during intubation.
Video laryngoscopy with GlidescopeDevice
Video laryngoscopy to be performed using theGlideScope (Verathon Inc., Bothell, USA) during intubation.
| Study group | Role | What they receive |
|---|---|---|
| Video laryngoscopy with visionPRO | Experimental | Video laryngoscopy will be performed with the visionPRO (HEINE® Optotechnick, Gilching, Germany) Receives: Device: Video laryngoscopy with visionPRO |
| Video laryngoscopy with Glidescope | Active comparator | Video laryngoscopy will be performed with the GlideScope (Verathon Inc., Bothell, USA) Receives: Device: Video laryngoscopy with Glidescope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial or first-pass success rate of indirect video laryngoscope endotracheal intubation (ET)
The primary outcome compares the initial or first-pass success rate of indirect video laryngoscope endotracheal intubation (ET) with the HyMac blade of the visionPRO (HEINE® Optotechnick, Gilching, Germany) to the hyperangulated blade of the GlideScope (Verathon Inc., Bothell, USA) in patients undergoing elective surgery and requiring tracheal intubation. This will be measured by recording how long it takes for successful intubation to take place using the above-mentioned devices, and any complications that may have arisen during the intubation procedure.
Measured: 0-120 seconds for first pass intubation attempt.
Secondary outcomes (1)
Incidence and severity of patient-reported postoperative sore throat (POST) during the first 24 hours
The secondary outcome compares the incidence and severity of patient-reported postoperative sore throat (POST) during the first 24 hours. This will be measured by asking patients to rate any occurrence of sore throat on a scale of 0-3 (0 meaning no sore throat and 3 meaning severe sore throat) 24 hours following surgery
Measured: 24 hours following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Intubation; Difficult or FailedStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruediger Noppens, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Ruediger Noppens, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676462
- Sponsor's protocol ID
- visionPRO vs. Glidescope
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kriege M, Noppens RR, Turkstra T, Payne S, Kunitz O, Tzanova I, Schmidtmann I; EMMA Trial Investigators Group. A multicentre randomised controlled trial of the McGrath Mac videolaryngoscope versus conventional laryngoscopy. Anaesthesia. 2023 Jun;78(6):722-729. doi: 10.1111/anae.15985. Epub 2023 Mar 16.
PubMed 36928625Yeatts DJ, Dutton RP, Hu PF, Chang YW, Brown CH, Chen H, Grissom TE, Kufera JA, Scalea TM. Effect of video laryngoscopy on trauma patient survival: a randomized controlled trial. J Trauma Acute Care Surg. 2013 Aug;75(2):212-9. doi: 10.1097/TA.0b013e318293103d.
PubMed 23823612Aziz MF, Healy D, Kheterpal S, Fu RF, Dillman D, Brambrink AM. Routine clinical practice effectiveness of the Glidescope in difficult airway management: an analysis of 2,004 Glidescope intubations, complications, and failures from two institutions. Anesthesiology. 2011 Jan;114(1):34-41. doi: 10.1097/ALN.0b013e3182023eb7.
PubMed 21150569Ruetzler K, Bustamante S, Schmidt MT, Almonacid-Cardenas F, Duncan A, Bauer A, Turan A, Skubas NJ, Sessler DI; Collaborative VLS Trial Group. Video Laryngoscopy vs Direct Laryngoscopy for Endotracheal Intubation in the Operating Room: A Cluster Randomized Clinical Trial. JAMA. 2024 Apr 16;331(15):1279-1286. doi: 10.1001/jama.2024.0762.
PubMed 38497992Noppens RR, Mobus S, Heid F, Schmidtmann I, Werner C, Piepho T. Evaluation of the McGrath Series 5 videolaryngoscope after failed direct laryngoscopy. Anaesthesia. 2010 Jul;65(7):716-20. doi: 10.1111/j.1365-2044.2010.06388.x. Epub 2010 Jun 7.
PubMed 20528841Kaplan A, Goksu E, Yildiz G, Kilic T. Comparison of the C-MAC Videolaryngoscope and Rigid Fiberscope with Direct Laryngoscopy in Easy and Difficult Airway Scenarios: A Manikin Study. J Emerg Med. 2016 Mar;50(3):e107-14. doi: 10.1016/j.jemermed.2015.06.070. Epub 2015 Dec 22.
PubMed 26725922Savoldelli GL, Schiffer E, Abegg C, Baeriswyl V, Clergue F, Waeber JL. Learning curves of the Glidescope, the McGrath and the Airtraq laryngoscopes: a manikin study. Eur J Anaesthesiol. 2009 Jul;26(7):554-8. doi: 10.1097/eja.0b013e3283269ff4.
PubMed 19522050Sakles JC, Javedani PP, Chase E, Garst-Orozco J, Guillen-Rodriguez JM, Stolz U. The use of a video laryngoscope by emergency medicine residents is associated with a reduction in esophageal intubations in the emergency department. Acad Emerg Med. 2015 Jun;22(6):700-7. doi: 10.1111/acem.12674. Epub 2015 May 20.
PubMed 25996773Hasegawa K, Shigemitsu K, Hagiwara Y, Chiba T, Watase H, Brown CA 3rd, Brown DF; Japanese Emergency Medicine Research Alliance Investigators. Association between repeated intubation attempts and adverse events in emergency departments: an analysis of a multicenter prospective observational study. Ann Emerg Med. 2012 Dec;60(6):749-754.e2. doi: 10.1016/j.annemergmed.2012.04.005. Epub 2012 Apr 28.
PubMed 22542734Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents. doi: 10.1213/01.ANE.0000122825.04923.15.
PubMed 15271750Law JA, Duggan LV, Asselin M, Baker P, Crosby E, Downey A, Hung OR, Jones PM, Lemay F, Noppens R, Parotto M, Preston R, Sowers N, Sparrow K, Turkstra TP, Wong DT, Kovacs G; Canadian Airway Focus Group. Canadian Airway Focus Group updated consensus-based recommendations for management of the difficult airway: part 1. Difficult airway management encountered in an unconscious patient. Can J Anaesth. 2021 Sep;68(9):1373-1404. doi: 10.1007/s12630-021-02007-0. Epub 2021 Jun 18.
PubMed 34143394Law JA, Duggan LV, Asselin M, Baker P, Crosby E, Downey A, Hung OR, Kovacs G, Lemay F, Noppens R, Parotto M, Preston R, Sowers N, Sparrow K, Turkstra TP, Wong DT, Jones PM; Canadian Airway Focus Group. Canadian Airway Focus Group updated consensus-based recommendations for management of the difficult airway: part 2. Planning and implementing safe management of the patient with an anticipated difficult airway. Can J Anaesth. 2021 Sep;68(9):1405-1436. doi: 10.1007/s12630-021-02008-z. Epub 2021 Jun 8.
PubMed 34105065Hansel J, Rogers AM, Lewis SR, Cook TM, Smith AF. Videolaryngoscopy versus direct laryngoscopy for adults undergoing tracheal intubation. Cochrane Database Syst Rev. 2022 Apr 4;4(4):CD011136. doi: 10.1002/14651858.CD011136.pub3.
PubMed 35373840Hansel J, Rogers AM. Mirror, mirror, on the wall, which is the best videolaryngoscope of them all? Anaesthesia. 2022 Apr;77(4):493. doi: 10.1111/anae.15654. Epub 2021 Dec 26. No abstract available.
PubMed 34957546de Carvalho CC, da Silva DM, Lemos VM, Dos Santos TGB, Agra IC, Pinto GM, Ramos IB, Costa YSC, Santos Neto JM. Videolaryngoscopy vs. direct Macintosh laryngoscopy in tracheal intubation in adults: a ranking systematic review and network meta-analysis. Anaesthesia. 2022 Mar;77(3):326-338. doi: 10.1111/anae.15626. Epub 2021 Dec 1.
PubMed 34855986
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Comparing the HEINE visionPRO HyMac 3 and the GlideScope Hyperangulated S3 Laryngoscope Blade on Time to Intubation
- ClinicalTrials.gov ID
- NCT06676462
- Acronym / sponsor ID
- visionPRO vs. Glidescope
- Conditions
- Intubation; Difficult or Failed, Intubation Complication, Video Laryngoscopy, Airway Management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 6 Nov 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.
Indirect video laryngoscope tracheal intubation with the GlideScope (Verathon Inc., Bothell, USA) has become a well-established technique in emergency and clinical anaesthesia, offering first-pass intubation success rates comparable to those achieved with direct laryngoscopy. Different video laryngoscopes vary significantly in design, including blade shape, mobility, and camera operation, which can affect patient outcomes. Two video laryngoscopes with hyperangulated blades include the GlideScope (Verathon Inc., Bothell, USA) and the visionPRO (HEINE® Optotechnick, Gilching, Germany). The Glidescope comprises an external monitor connected to a medical-grade plastic handle which is compatible with reusable and disposable blades. The newer visionPro comprises a reusable anodized aluminum integrated monitor that is attached to the camera/handle which is compatible with disposable blades. The hyperangulated blade of the VisionPro is a unique combination of previously designed laryngoscope blades meant to increase performance. The introduction of this new hyperangulated blade design in the VisionPro raises the need to compare its performance against the established GlideScope.
The aim of this pilot study is to generate initial data to evaluate whether the use of the visionPRO (HEINE® Optotechnick, Gilching, Germany) provides a non-inferior first-pass success rate compared with the GlideScope (Verathon Inc., Bothell, USA) in surgical patients with an expected normal airway undergoing general anaesthesia The investigators hypothesize that tracheal intubation using the HEINE visionPRO will achieve a similar frequency of failed intubation and airway complications. This study plans to recruit 100 patients.
Detailed description
This trial is a single-centre, pilot, patient-blinded, randomized controlled non-inferiority trial.
Patients who decide to participate in this study will have their surgery and follow up care proceed according to standard of care. Video laryngoscopy is standard of care for this patient population at LHSC. Once eligibility is confirmed and informed, written consent has been obtained, participants be randomized to one of two study groups:
- Laryngoscopy performed using the Glidescope device (Verathon Inc., Bothell, USA)
- Laryngoscopy performed using the visionPRO device (HEINE® Optotechnick, Gilching, Germany)
Surgery, anesthetic management, and intubation protocol will proceed according to standard of care.
(A) All patients are observed for ECG, oxygen saturation (SpO2), and non-invasive blood pressure. Pre-oxygenation is carried out by the provider based on patient characteristics and standard clinical procedures (EtO2 > 80%).
(B) After adequate pre-oxygenation, anaesthesia is initiated using a combination of fentanyl (0.1 - 0.15 µg.kg-1) / sufentanil (0.2 - 0.5 µg.kg-1), and propofol (2 - 3 mg.kg-1), with the choice of drugs and dosages tailored to the specific needs of the patient. Maintenance is achieved either through propofol infusion (TIVA) or inhaled anaesthetics. The selection of a neuromuscular blocking agent is based on the surgery's duration, the need for perioperative neurological monitoring, and the absence of allergies and organ failures. The agents and their dosages used are:
- Rocuronium (0.5 - 1.2 mg.kg-1); and
- Succinylcholine (1 - 2 mg.kg-1).
The train-of-four (TOF) method is employed by the study nurse for continuous quantitative monitoring of neuromuscular transmission. Complete muscle relaxation is confirmed by the absence of tactile and measured twitches in response to maximal TOF stimulation of the ulnar nerve at the adductor pollicis. Study personnel were instructed on the importance of achieving adequate neuromuscular blockade.
(C) The laryngoscopy attempt starts with a TOF count of 0/4, using the device specified by randomization:
- visionPRO (HEINE® Optotechnick, Gilching, Germany) or
- GlideScope (Verathon Inc., Bothell, USA)
The provider aims to achieve the clearest view of the laryngeal structures. External laryngeal manipulations (ELM) may be employed to enhance the view of the glottis, aiming for a Cormack and Lehane grade I or II. The endotracheal tube size and blade size are chosen according to the hospital's standard operating procedures (blade size: #3 for average patients, #4 for taller patients; standard ET sizes: 7.0-7.5 ID for female patients and 7.5-8.0 ID for male patients). The method of glottic visualization and the size of the ET and blade are documented in the case report form (CRF).
(D) An intubation attempt is defined as the insertion and removal of the laryngoscope blade from the mouth, regardless of ET insertion success. A laryngoscopy attempt is considered successful if the tracheal tube is placed with a single blade insertion within 120 seconds and without manipulation of the laryngoscope by another provider. The following times periods until final ET placement are measured by a study nurse via a timer:
- "Time to intubation": duration from the opening of the patient's mouth to the passage of the ET through the vocal cords.
- "Time to view": the time from device insertion to visualization of the glottis;
- "Time to ventilation": the time from device insertion into the mouth until confirmation of the first CO2 wave on the anaesthesia respirator.
If the first attempt fails, the provider makes a second attempt with the same device, with mask ventilation recommended between attempts. A maximum of two laryngoscopy attempts are allowed. After two attempts the clinician switches to a preferred technique and records the direct and/or screen view. If this preferred technique fails after two attempts, the clinician proceeds with a preferred rescue technique. The study protocol recommends this limit of two intubation attempts and alternative technique selection in line with clinical standards. If ELM techniques, such as BURP (specific pressure applied to the cricoid cartilage), are needed during laryngoscopy, they are documented in the CRF. Throughout the induction of anaesthesia, a study nurse not involved in patient care records the study parameters.
24 hours following surgery, the patient will be assessed for presence and severity of sore throat rated on a scale of 0-3 (0 meaning no sore throat and 3 meaning severe sore throat), hoarseness rated on a scale of 0-3 (0 meaning no complaint and 3 meaning severe hoarseness), and cough rated on a scale of 0-3 (0 meaning no cough and 3 meaning severe cough).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video laryngoscopy with visionPRO | Experimental | Device: Video laryngoscopy with visionPROVideo laryngoscopy will be performed with the visionPRO (HEINE® Optotechnick, Gilching, Germany) |
| Video laryngoscopy with Glidescope | Active comparator | Device: Video laryngoscopy with GlidescopeVideo laryngoscopy will be performed with the GlideScope (Verathon Inc., Bothell, USA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having elective surgery with general anesthesia
- At least 18 years of age
- requiring mechanical ventilation via an oral endotracheal tube
Key exclusion criteria (8 listed)
- More than one predictor of an anticipated difficult airway (eg, body mass index (BMI) >40 kg/m2, unanticipated difficult airway in the medical history (eg, Cormack \& Lehane (C\&L) ≥III), reduction of the atlanto-occipital joint extension <35°, reduced thyromental distance <6 cm or Mallampati class ≥III)
- Age <18 years
- ASA class IV-VI
- Pregnant or breastfeeding
- Unable to provide informed written consent or under guardianship
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 |
|---|---|---|
| Video laryngoscopy with visionPROVideo laryngoscopy to be performed using the visionPRO (HEINE® Optotechnick, Gilching, Germany) during intubation. | Device | Video laryngoscopy with visionPRO |
| Video laryngoscopy with GlidescopeVideo laryngoscopy to be performed using theGlideScope (Verathon Inc., Bothell, USA) during intubation. | Device | Video laryngoscopy with Glidescope |
Primary outcome
Initial or first-pass success rate of indirect video laryngoscope endotracheal intubation (ET)
Time frame: 0-120 seconds for first pass intubation attempt.
The primary outcome compares the initial or first-pass success rate of indirect video laryngoscope endotracheal intubation (ET) with the HyMac blade of the visionPRO (HEINE® Optotechnick, Gilching, Germany) to the hyperangulated blade of the GlideScope (Verathon Inc., Bothell, USA) in patients undergoing elective surgery and requiring tracheal intubation. This will be measured by recording how long it takes for successful intubation to take place using the above-mentioned devices, and any complications that may have arisen during the intubation procedure.
1 secondary outcome
Incidence and severity of patient-reported postoperative sore throat (POST) during the first 24 hours
Time frame: 24 hours following surgery
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 6 Nov 2024.
- Background: PubMed 36928625Kriege M, Noppens RR, Turkstra T, Payne S, Kunitz O, Tzanova I, Schmidtmann I; EMMA Trial Investigators Group. A multicentre randomised controlled trial of the McGrath Mac videolaryngoscope versus conventional laryngoscopy. Anaesthesia. 2023 Jun;78(6):722-729. doi: 10.1111/anae.15985. Epub 2023 Mar 16.
- Background: PubMed 23823612Yeatts DJ, Dutton RP, Hu PF, Chang YW, Brown CH, Chen H, Grissom TE, Kufera JA, Scalea TM. Effect of video laryngoscopy on trauma patient survival: a randomized controlled trial. J Trauma Acute Care Surg. 2013 Aug;75(2):212-9. doi: 10.1097/TA.0b013e318293103d.
- Background: PubMed 21150569Aziz MF, Healy D, Kheterpal S, Fu RF, Dillman D, Brambrink AM. Routine clinical practice effectiveness of the Glidescope in difficult airway management: an analysis of 2,004 Glidescope intubations, complications, and failures from two institutions. Anesthesiology. 2011 Jan;114(1):34-41. doi: 10.1097/ALN.0b013e3182023eb7.
- Background: PubMed 38497992Ruetzler K, Bustamante S, Schmidt MT, Almonacid-Cardenas F, Duncan A, Bauer A, Turan A, Skubas NJ, Sessler DI; Collaborative VLS Trial Group. Video Laryngoscopy vs Direct Laryngoscopy for Endotracheal Intubation in the Operating Room: A Cluster Randomized Clinical Trial. JAMA. 2024 Apr 16;331(15):1279-1286. doi: 10.1001/jama.2024.0762.
- Background: PubMed 20528841Noppens RR, Mobus S, Heid F, Schmidtmann I, Werner C, Piepho T. Evaluation of the McGrath Series 5 videolaryngoscope after failed direct laryngoscopy. Anaesthesia. 2010 Jul;65(7):716-20. doi: 10.1111/j.1365-2044.2010.06388.x. Epub 2010 Jun 7.
- Background: PubMed 26725922Kaplan A, Goksu E, Yildiz G, Kilic T. Comparison of the C-MAC Videolaryngoscope and Rigid Fiberscope with Direct Laryngoscopy in Easy and Difficult Airway Scenarios: A Manikin Study. J Emerg Med. 2016 Mar;50(3):e107-14. doi: 10.1016/j.jemermed.2015.06.070. Epub 2015 Dec 22.
- Background: PubMed 19522050Savoldelli GL, Schiffer E, Abegg C, Baeriswyl V, Clergue F, Waeber JL. Learning curves of the Glidescope, the McGrath and the Airtraq laryngoscopes: a manikin study. Eur J Anaesthesiol. 2009 Jul;26(7):554-8. doi: 10.1097/eja.0b013e3283269ff4.
- Background: PubMed 25996773Sakles JC, Javedani PP, Chase E, Garst-Orozco J, Guillen-Rodriguez JM, Stolz U. The use of a video laryngoscope by emergency medicine residents is associated with a reduction in esophageal intubations in the emergency department. Acad Emerg Med. 2015 Jun;22(6):700-7. doi: 10.1111/acem.12674. Epub 2015 May 20.
- Background: PubMed 22542734Hasegawa K, Shigemitsu K, Hagiwara Y, Chiba T, Watase H, Brown CA 3rd, Brown DF; Japanese Emergency Medicine Research Alliance Investigators. Association between repeated intubation attempts and adverse events in emergency departments: an analysis of a multicenter prospective observational study. Ann Emerg Med. 2012 Dec;60(6):749-754.e2. doi: 10.1016/j.annemergmed.2012.04.005. Epub 2012 Apr 28.
- Background: PubMed 15271750Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents. doi: 10.1213/01.ANE.0000122825.04923.15.
- Background: PubMed 34143394Law JA, Duggan LV, Asselin M, Baker P, Crosby E, Downey A, Hung OR, Jones PM, Lemay F, Noppens R, Parotto M, Preston R, Sowers N, Sparrow K, Turkstra TP, Wong DT, Kovacs G; Canadian Airway Focus Group. Canadian Airway Focus Group updated consensus-based recommendations for management of the difficult airway: part 1. Difficult airway management encountered in an unconscious patient. Can J Anaesth. 2021 Sep;68(9):1373-1404. doi: 10.1007/s12630-021-02007-0. Epub 2021 Jun 18.
- Background: PubMed 34105065Law JA, Duggan LV, Asselin M, Baker P, Crosby E, Downey A, Hung OR, Kovacs G, Lemay F, Noppens R, Parotto M, Preston R, Sowers N, Sparrow K, Turkstra TP, Wong DT, Jones PM; Canadian Airway Focus Group. Canadian Airway Focus Group updated consensus-based recommendations for management of the difficult airway: part 2. Planning and implementing safe management of the patient with an anticipated difficult airway. Can J Anaesth. 2021 Sep;68(9):1405-1436. doi: 10.1007/s12630-021-02008-z. Epub 2021 Jun 8.
- 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.
Ruediger Noppens principal investigator
Western University
Questions about this trial
What is this clinical trial studying?
A study testing Video laryngoscopy with visionPRO and Video laryngoscopy with Glidescope in people with Intubation; Difficult or Failed and Intubation Complication, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Ruediger Noppens, MD (5196858500 ext. 13707, ruediger.noppens@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial or first-pass success rate of indirect video laryngoscope endotracheal intubation (ET) (time frame: 0-120 seconds for first pass intubation attempt.). 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 NCT06676462, which also lists 33 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 6 Nov 2024; AzTrials last refreshed its copy on 26 Oct 2026.