New guidelines for research in airway device evaluation: time for an updated approach (ADEPT-2) to the Difficult Airway Society’s ‘ADEPT’ strategy?

Athanassoglou, Vassilis; O’Sullivan, E.; Zundert, André van; Pandit, J. J.

doi:10.1007/s10877-022-00911-4

Cited by 5 publications

(5 citation statements)

References 29 publications

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“…Ours is not the first reported trial of the LMA Protector. Sng et al's description in 2017 [22] was in fact contemporaneous with the planning of our own trial, and the delays we then encountered are described in the accompanying article [9], and since then there exist over a dozen reports, including description of its use in different patient positions, emergency and elective settings, and for facilitating use of fibrescopy [13,23,24]. However, whereas most of these are individual case series or relatively small (but albeit appropriately statistically powered) randomised trials, ours is arguably the first study of a diverse patient cohort in real world settings.…”

Section: Discussionmentioning

confidence: 86%

“…This proliferation of SADs, coupled with a recognised lack of clinical evidence supporting use of the new devises before they were brought to market led the Difficult Airway Society (DAS) to develop guidance (termed ADEPT after the Airway Device Project Evaluation Team) as a framework under which clinical studies could be facilitated [8]. It was under this framework (described further in an accompanying article [9]) that we undertook a prospective observational cohort study of the LMA® Protector™ to investigate its clinical performance characteristics.…”

Section: Introductionmentioning

confidence: 99%

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Assessing a novel second generation laryngeal mask airway using the ‘ADEPT’ approach: results from the LMA® Protector™ observational study

Eochagáin

Athanassoglou

Cumberworth

et al. 2022

J Clin Monit Comput

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To address the problem of lack of clinical evidence for airway devices introduced to the market, the Difficult Airway Society (UK) developed an approach (termed ADEPT; Airway Device Evaluation Project Team) to standardise the model for device evaluation. Under this framework we assessed the LMA Protector, a second generation laryngeal mask airway. A total of 111 sequential adult patients were recruited and the LMA Protector inserted after induction of general anaesthesia. Effective insertion was confirmed by resistance to further distal movement, manual ventilation, and listening for gas leakage at the mouth. The breathing circuit was connected to the airway channel and airway patency confirmed with manual test ventilation at 20 cm H20 (water) pressure for 3 s. Data was collected in relation to the time for placement, intraoperative performance and postoperative performance of the airway device. Additionally, investigators rated the ease of insertion and adequacy of lung ventilation on a 5-point scale. The median (interquartile range [range]) time taken to insertion of the device was 31 (26–40[14–780]) s with the ability to ventilate after device insertion 100 (95% CI 96.7- 100)%. Secondary endpoints included one or more manoeuvres 60.3 (95% CI 50.6—69.5)% cases requiring to assist insertion; a median ease of insertion score of 4 (2–5[3–5]), and a median adequacy of ventilation score of 5 (5–5[4–5]). However, the first time insertion rate failure was 9.9% (95% CI 5.1—17.0%). There were no episodes of patient harm recorded, particularly desaturation. The LMA Protector appears suitable for clinical use, but an accompanying article discusses our reflections on the ADEPT approach to studying airway devices from a strategic perspective.

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Section: Discussionmentioning

confidence: 86%

Section: Introductionmentioning

confidence: 99%

Assessing a novel second generation laryngeal mask airway using the ‘ADEPT’ approach: results from the LMA® Protector™ observational study

Eochagáin

Athanassoglou

Cumberworth

et al. 2022

J Clin Monit Comput

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“…This study followed the recommendations suggested by ADEPT [9] and ADEPT-2 [10] initiatives and, in a large sample, focused on the clinically important primary outcome, the total success rate of the i-gel Plus insertion. The interim results of this trial showed that the total success rate of the device insertion is reasonably high in both males and females.…”

Section: Discussionmentioning

confidence: 99%

An evaluation of the i-gel Plus supraglottic airway device in elective patients: the interim results from a prospective international multicentre study

Werner,

Klementova,

Bruthans

et al. 2024

Preprint

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The i-gel Plus supraglottic airway represents the next generation of the i-gel device. The aim of this international multicentre prospective cohort study was to evaluate its performance in adult patients during elective procedures in various surgical disciplines under general anaesthesia. The primary outcome of the study was the overall success rate of insertion allowing effective airway management, ventilation, and oxygenation. The secondary outcomes included perioperative performance of the device and the incidence of postoperative adverse events. The data of the first 1000 patients from our study (455 males and 545 females) are presented. These patients were mostly operated on in the supine position (83.3%) with a minority of them being in the lateral or lithotomy positions. The overall success rate was 98.6%, with a first-attempt success rate of insertion of 88.1%. A significant difference between males and females was seen for the overall success rate, 97.4% vs. 99.6% (p=0.002) but not for the successful insertion on the first attempt (p=0.97) The mean oropharyngeal seal pressure was 32 (7) cmH2O. The only independent factor increasing the risk of first-attempt failure was low experience of the operator (p<0.001). The insertion of the device was rated by 80.3% as being either very easy or easy. Fibreoptic assessment through the i-gel Plus showed a full view of the vocal cords in 67.8% of patients, a partial view in 21.9% and a downfolded epiglottis in 9.4% of patients. A gastric tube was inserted in 11.2% of patients with a 99.1% success rate. Perioperative complications included desaturation below 85% in 0.6%, traces of blood on the device in 7.4%, laryngospasm in 0.5% and gastric contents inside the cuff in 0.2% of patients. There were no clinical signs of aspiration and a 0.1% incidence of bronchospasm. Severe postoperative sore throat was recorded in 1.4%, and long-term hoarse voice in 0.2% of patients. All patients with moderate and serious postoperative complaints are being followed up by phone at 3 and 6 months. The i-gel Plus seems to be an effective supraglottic airway device providing a high success rate of insertion, sufficient oropharyngeal seal pressure, and a reasonably low incidence of complications.

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“…9 The first formal trial under this program was recently published, 10 and moreover, updated recommendations (ADEPT-2) have been proposed. 11 The performance of SGDs, which can range from easy to problematic, depends on patient factors, the anesthetic plan (including urgency of any intervention) and the SGD design (including dimensions and material). Some SGDs are bulkier than others.…”

Section: Anesthesia and Analgesiamentioning

confidence: 99%

“…9 The first formal trial under this program was recently published, 10 and moreover, updated recommendations (ADEPT-2) have been proposed. 11…”

mentioning

confidence: 99%

Supraglottic Airway Devices: Present State and Outlook for 2050

van Zundert,

Gatt,

van Zundert

et al. 2024

Anesthesia &Amp; Analgesia

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Correct placement of supraglottic airway devices (SGDs) is crucial for patient safety and of prime concern of anesthesiologists who want to provide effective and efficient airway management to their patients undergoing surgery or procedures requiring anesthesia care. In the majority of cases, blind insertion of SGDs results in less-than-optimal anatomical and functional positioning of the airway devices. Malpositioning can cause clinical malfunction and result in interference with gas exchange, loss-of-airway, gastric inflation, and aspiration of gastric contents. A close match is needed between the shape and profile of SGDs and the laryngeal inlet. An adequate first seal (with the respiratory tract) and a good fit at the second seal of the distal cuff and the gastrointestinal tract are most desirable. Vision-guided insertion techniques are ideal and should be the way forward. This article recommends the use of third-generation vision-incorporated-video SGDs, which allow for direct visualization of the insertion process, corrective maneuvers, and, when necessary, insertion of a nasogastric tube (NGT) and/or endotracheal tube (ETT) intubation. A videoscope embedded within the SGD allows a visual check of the glottis opening and position of the epiglottis. This design affords the benefit of confirming and/or correcting a SGD’s position in the midline and rotation in the sagittal plane. The first clinically available video laryngeal mask airways (VLMAs) and multiple prototypes are being tested and used in anesthesia. Existing VLMAs are still not perfect, and further improvements are recommended. Additional modifications in multicamera technology, to obtain a panoramic view of the SGD sitting correctly in the hypopharynx and to prove that correct sizes have been used, are in the process of production. Ultimately, any device inserted orally—SGD, ETT, NGT, temperature probe, transesophageal scope, neural integrity monitor (NIM) tubes—could benefit from correct vision-guided positioning. VLMAs also allow for automatic recording, which can be documented in clinical records of patients, and could be valuable during teaching and research, with potential value in case of legal defence (with an airway incident). If difficulties occur with the airway, documentation in the patient’s file may help future anesthesiologists to better understand the real-time problems. Both manufacturers and designers of SGDs may learn from optimally positioned SGDs to improve the design of these airway devices.

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New guidelines for research in airway device evaluation: time for an updated approach (ADEPT-2) to the Difficult Airway Society’s ‘ADEPT’ strategy?

Cited by 5 publications

References 29 publications

Assessing a novel second generation laryngeal mask airway using the ‘ADEPT’ approach: results from the LMA® Protector™ observational study

Assessing a novel second generation laryngeal mask airway using the ‘ADEPT’ approach: results from the LMA® Protector™ observational study

An evaluation of the i-gel Plus supraglottic airway device in elective patients: the interim results from a prospective international multicentre study

Supraglottic Airway Devices: Present State and Outlook for 2050

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