Non-inferiority Trial Comparing visionPRO to Glidescope Video Laryngoscopes

Официальное название

Pilot Study Comparing the HEINE visionPRO HyMac 3 and the GlideScope Hyperangulated S3 Laryngoscope Blade on Time to Intubation

Обзор

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.

Подробное описание

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:

1. Laryngoscopy performed using the Glidescope device (Verathon Inc., Bothell, USA) 2. 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:

1. Rocuronium (0.5 - 1.2 mg.kg-1); and 2. 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:

1. visionPRO (HEINE® Optotechnick, Gilching, Germany) or 2. 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:

1. "Time to intubation": duration from the opening of the patient's mouth to the passage of the ET through the vocal cords. 2. "Time to view": the time from device insertion to visualization of the glottis; 3. "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).

Вмешательства

• Устройство Video laryngoscopy with visionPRO
  Video laryngoscopy to be performed using the visionPRO (HEINE® Optotechnick, Gilching, Germany) during intubation.
• Устройство Video laryngoscopy with Glidescope
  Video laryngoscopy to be performed using theGlideScope (Verathon Inc., Bothell, USA) during intubation.

Первичные конечные точки

• Initial or first-pass success rate of indirect video laryngoscope endotracheal intubation (ET) [Срок оценки: 0-120 seconds for first pass intubation attempt.]

Вторичные конечные точки (1)

• Incidence and severity of patient-reported postoperative sore throat (POST) during the first 24 hours [Срок оценки: 24 hours following surgery]

Критерии участия

Критерии включения

• Having elective surgery with general anesthesia
• At least 18 years of age
• requiring mechanical ventilation via an oral endotracheal tube

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 36928625
• Yeatts 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. PMID 23823612
• Aziz 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. PMID 21150569
• Ruetzler 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. PMID 38497992
• Noppens 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. PMID 20528841
• Kaplan 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. PMID 26725922
• Savoldelli 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. PMID 19522050
• Sakles 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. PMID 25996773

Идентификаторы

NCT: NCT06676462 · visionPRO vs. Glidescope

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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