Hyperangulated versus Macintosh blades for intubation with videolaryngoscopy in ICU: the randomised multicentre INVIBLADE-ICU trial study protocol.
Compared with the operating room, tracheal intubations in the intensive care unit (ICU) are associated with worsened glottic view, decreased first-time success rate and increase in the technical difficulty of intubation and incidence of complications. Videolaryngoscopes (VLs) have been proposed to improve airway management, and while recent studies have confirmed that VLs improve intubation conditions in this patient population, there remains a lack of clarity regarding the selection between a standard Macintosh blade or a hyperangulated one, to determine which yields the best outcomes. The purpose of this study was to compare successful intubation on the first attempt with the Macintosh VL versus the hyperangulated VL during tracheal intubation in ICU patients. We hypothesise that tracheal intubation using the hyperangulated VL will improve the frequency of successful intubation on the first attempt.
The INtubation VIdeolaryngoscopy BLADE-ICU trial is a prospective, multicentre, open-label, interventional, randomised, controlled superiority study conducted in 29 ICUs in Spain. Patients will be randomly assigned in a 1:1 ratio to undergo intubation using a Macintosh VL (control group) or a hyperangulated VL (experimental group) for the first intubation attempt. The primary outcome is successful intubation on the first attempt. The secondary outcomes include the time to intubation, attempts for successful intubation, laryngoscopic vision assessed with the modified Cormack-Lehane scale, the need for adjuvant airway devices for intubation, difficulty assessed by the anaesthesiologist and complications during tracheal intubation. Enrolment began on 1 May 2024 and is expected to be completed in 2025.
The study protocol was approved on 29 February 2024, by the Ethics Committee of Galicia (CEImG, code No. 2024-031).The results will be submitted for publication in a peer-reviewed journal.
NCT06322719.
Taboada M
,Estany-Gestal A
,Fernández J
,Vazquez O
,Pajares A
,Ramasco F
,Martínez S
,Vallejo I
,Pérez A
,Rama-Maceiras P
,Bermúdez M
,Power M
,García-Álvarez R
,Fernández-Villa I
,Aguilera JL
,Carrió M
,Cabadas R
,Rubín A
,Williams MM
,Fernández-García R
,Becerra A
,Giné M
,García FJ
,Iglesias MC
,Santamarina RM
,Del Valle S
,Charco LM
,Alonso MC
,Rodríguez IM
,Varela M
,Hermoso JI
,Vives M
,Cabaleiro T
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《BMJ Open》
Videolaryngoscopy versus direct laryngoscopy for adults undergoing tracheal intubation.
Tracheal intubation is a common procedure performed to secure the airway in adults undergoing surgery or those who are critically ill. Intubation is sometimes associated with difficulties and complications that may result in patient harm. While it is traditionally achieved by performing direct laryngoscopy, the past three decades have seen the advent of rigid indirect videolaryngoscopes (VLs). A mounting body of evidence comparing the two approaches to tracheal intubation has been acquired over this period of time. This is an update of a Cochrane Review first published in 2016.
To assess whether use of different designs of VLs in adults requiring tracheal intubation reduces the failure rate compared with direct laryngoscopy, and assess the benefits and risks of these devices in selected population groups, users and settings.
We searched MEDLINE, Embase, CENTRAL and Web of Science on 27 February 2021. We also searched clinical trials databases, conference proceedings and conducted forward and backward citation searches.
We included randomized controlled trials (RCTs) and quasi-RCTs with adults undergoing laryngoscopy performed with either a VL or a Macintosh direct laryngoscope (DL) in any clinical setting. We included parallel and cross-over study designs.
We used standard methodological procedures expected by Cochrane. We collected data for the following outcomes: failed intubation, hypoxaemia, successful first attempt at tracheal intubation, oesophageal intubation, dental trauma, Cormack-Lehane grade, and time for tracheal intubation.
We included 222 studies (219 RCTs, three quasi-RCTs) with 26,149 participants undergoing tracheal intubation. Most studies recruited adults undergoing elective surgery requiring tracheal intubation. Twenty-one studies recruited participants with a known or predicted difficult airway, and an additional 25 studies simulated a difficult airway. Twenty-one studies were conducted outside the operating theatre environment; of these, six were in the prehospital setting, seven in the emergency department and eight in the intensive care unit. We report here the findings of the three main comparisons according to videolaryngoscopy device type. We downgraded the certainty of the outcomes for imprecision, study limitations (e.g. high or unclear risks of bias), inconsistency when we noted substantial levels of statistical heterogeneity and publication bias. Macintosh-style videolaryngoscopy versus direct laryngoscopy (61 studies, 9883 participants) We found moderate-certainty evidence that a Macintosh-style VL probably reduces rates of failed intubation (risk ratio (RR) 0.41, 95% confidence interval (CI) 0.26 to 0.65; 41 studies, 4615 participants) and hypoxaemia (RR 0.72, 95% CI 0.52 to 0.99; 16 studies, 2127 participants). These devices may also increase rates of success on the first intubation attempt (RR 1.05, 95% CI 1.02 to 1.09; 42 studies, 7311 participants; low-certainty evidence) and probably improve glottic view when assessed as Cormack-Lehane grade 3 and 4 (RR 0.38, 95% CI 0.29 to 0.48; 38 studies, 4368 participants; moderate-certainty evidence). We found little or no clear difference in rates of oesophageal intubation (RR 0.51, 95% CI 0.22 to 1.21; 14 studies, 2404 participants) but this finding was supported by low-certainty evidence. We were unsure of the findings for dental trauma because the certainty of this evidence was very low (RR 0.68, 95% CI 0.16 to 2.89; 18 studies, 2297 participants). We were not able to pool data for time required for tracheal intubation owing to considerable heterogeneity (I2 = 96%). Hyperangulated videolaryngoscopy versus direct laryngoscopy (96 studies, 11,438 participants) We found moderate-certainty evidence that hyperangulated VLs probably reduce rates of failed intubation (RR 0.51, 95% CI 0.34 to 0.76; 63 studies, 7146 participants) and oesophageal intubation (RR 0.39, 95% CI 0.18 to 0.81; 14 studies, 1968 participants). In subgroup analysis, we noted that hyperangulated VLs were more likely to reduce failed intubation when used on known or predicted difficult airways (RR 0.29, 95% CI 0.17 to 0.48; P = 0.03 for subgroup differences; 15 studies, 1520 participants). We also found that these devices may increase rates of success on the first intubation attempt (RR 1.03, 95% CI 1.00 to 1.05; 66 studies, 8086 participants; low-certainty evidence) and the glottic view is probably also improved (RR 0.15, 95% CI 0.10 to 0.24; 54 studies, 6058 participants; data for Cormack-Lehane grade 3/4 views; moderate-certainty evidence). However, we found low-certainty evidence of little or no clear difference in rates of hypoxaemia (RR 0.49, 95% CI 0.22 to 1.11; 15 studies, 1691 participants), and the findings for dental trauma were unclear because the certainty of this evidence was very low (RR 0.51, 95% CI 0.16 to 1.59; 30 studies, 3497 participants). We were not able to pool data for time required for tracheal intubation owing to considerable heterogeneity (I2 = 99%). Channelled videolaryngoscopy versus direct laryngoscopy (73 studies, 7165 participants) We found moderate-certainty evidence that channelled VLs probably reduce rates of failed intubation (RR 0.43, 95% CI 0.30 to 0.61; 53 studies, 5367 participants) and hypoxaemia (RR 0.25, 95% CI 0.12 to 0.50; 15 studies, 1966 participants). They may also increase rates of success on the first intubation attempt (RR 1.10, 95% CI 1.05 to 1.15; 47 studies, 5210 participants; very low-certainty evidence) and probably improve glottic view (RR 0.14, 95% CI 0.09 to 0.21; 40 studies, 3955 participants; data for Cormack-Lehane grade 3/4 views; moderate-certainty evidence). We found little or no clear difference in rates of oesophageal intubation (RR 0.54, 95% CI 0.17 to 1.75; 16 studies, 1756 participants) but this was supported by low-certainty evidence. We were unsure of the findings for dental trauma because the certainty of the evidence was very low (RR 0.52, 95% CI 0.13 to 2.12; 29 studies, 2375 participants). We were not able to pool data for time required for tracheal intubation owing to considerable heterogeneity (I2 = 98%).
VLs of all designs likely reduce rates of failed intubation and result in higher rates of successful intubation on the first attempt with improved glottic views. Macintosh-style and channelled VLs likely reduce rates of hypoxaemic events, while hyperangulated VLs probably reduce rates of oesophageal intubation. We conclude that videolaryngoscopy likely provides a safer risk profile compared to direct laryngoscopy for all adults undergoing tracheal intubation.
Hansel J
,Rogers AM
,Lewis SR
,Cook TM
,Smith AF
... -
《Cochrane Database of Systematic Reviews》
Hyperangulated vs. Macintosh videolaryngoscopy in adults with anticipated difficult airway management: a randomised controlled trial.
It is not certain whether the blade geometry of videolaryngoscopes, either a hyperangulated or Macintosh shape, affects glottic view, success rate and/or tracheal intubation time in patients with expected difficult airways. We hypothesised that using a hyperangulated videolaryngoscope blade would visualise a higher percentage of glottic opening compared with a Macintosh videolaryngoscope blade in patients with expected difficult airways.
We conducted an open-label, patient-blinded, randomised controlled trial in adult patients scheduled to undergo elective ear, nose and throat or oral and maxillofacial surgery, who were anticipated to have a difficult airway. All airway operators were consultant anaesthetists. Patients were allocated randomly to tracheal intubation with either hyperangulated (C-MAC D-BLADE™) or Macintosh videolaryngoscope blades (C-MAC™). The primary outcome was the percentage of glottic opening. First attempt success was designated a key secondary outcome.
We assessed 2540 adults scheduled for elective head and neck surgery for eligibility and included 182 patients with expected difficult airways undergoing orotracheal intubation. The percentage of glottic opening visualised, expressed as median (IQR [range]), was 89 (69-99 [0-100])% with hyperangulated videolaryngoscope blades and 54 (9-90 [0-100])% with Macintosh videolaryngoscope blades (p < 0.001). First-line hyperangulated videolaryngoscopy failed in one patient and Macintosh videolaryngoscopy in 12 patients (13%, p = 0.002). First attempt success rate was 97% with hyperangulated videolaryngoscope blades and 67% with Macintosh videolaryngoscope blades (p < 0.001).
Glottic view and first attempt success rate were superior with hyperangulated videolaryngoscope blades compared with Macintosh videolaryngoscope blades when used by experienced anaesthetists in patients with difficult airways.
Köhl V
,Wünsch VA
,Müller MC
,Sasu PB
,Dohrmann T
,Peters T
,Tolkmitt J
,Dankert A
,Krause L
,Zöllner C
,Petzoldt M
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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.
Standard tracheal intubation performed in the operating room is based on direct laryngoscopy using a standard Macintosh laryngoscope. Several authors recommend the universal use of a video laryngoscope as the first option for all intubations, regardless of whether the patient has predictors of a difficult airway or not. We hypothesize that using the McGrath video laryngoscope as the first intubation option increases the frequency of patients with easy intubation, and decreases intubation-related complications.
The VIDEOLAR-SURGERY trial is a prospective, multicentre, open-label, interventional, before-after study. In the pre-implementation period (non-interventional phase, 6-9 months [2600 intubations]), 35 anaesthesiologists from 8 hospitals perform all tracheal intubations for an elective or urgent surgical procedure using the standard Macintosh direct laryngoscope as the first intubation option. During the implementation period (2 months), each anaesthesiologist is given a McGrath Mac video laryngoscope and trained in its use. During the post-implementation period (interventional-phase, 6-9 months [2600 intubations]), the 35 anaesthesiologists perform all tracheal intubations using a McGrath Mac video laryngoscope as the first intubation option. The main objective of this study is to evaluate whether the use of a McGrath Mac video laryngoscope as the first intubation option increases the percentage of patients with easy intubation compared with the standard Macintosh laryngoscope.
The study protocol was approved on 2 May 2023 by the Ethics Committee of Galicia, Spain (CEI-SL, code No. 2023-177), and was registered on the Clinicaltrials.gov clinical trials registry under No. NCT NCT05850260. Informed consent is required. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences. If video laryngoscopy improves easy intubation compared with Macintosh direct laryngoscopy in all operating room intubations, its use may well become standard practice, thereby decreasing the risks of intubation-related complications.
Taboada M
,Estany-Gestal A
,Rama-Maceiras P
,Orallo MA
,Bermúdez M
,Barreiro C
,Gómez L
,Amor M
,Otero F
,Fernández 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
,Martín L
,Campaña D
,Mosquera E
,Novoa C
,Varela S
,da Silva L
,Domínguez E
,Bedoya A
,Gómez AI
,Estévez M
,Martínez P
,Sotojove R
,Naveiro A
,Díaz C
,Ruido R
,Mirón P
,González M
,Francisco C
,Regueira J
,Peiteado M
,Eiras M
,Paz E
... -
《-》
Channelled versus nonchannelled Macintosh videolaryngoscope blades in patients with a cervical collar: a randomized controlled noninferiority trial.
Channelled blades have the advantage of avoiding stylet use and potential airway injury during videolaryngoscopic intubation. Nevertheless, the effectiveness of channelled Macintosh-type blades has not yet been fully established. We sought to assess the utility of channelled Macintosh-type blades for videolaryngoscopic intubation under cervical spine immobilization.
We conducted a randomized controlled noninferiority trial in neurosurgical patients with a difficult airway simulated by a cervical collar. Videolaryngoscopic intubation with a reinforced tracheal tube was performed using a channelled Macintosh-type blade without a stylet (channelled group, n = 130) or a nonchannelled Macintosh-type blade with a stylet (nonchannelled group, n = 131). The primary outcome was intubation success rate. Secondary outcomes included time to intubation and incidence or severity of intubation-related complications (subglottic, lingual, and dental injuries; bleeding; sore throat; and hoarseness).
The initial intubation success rate was 98% and 99% in the channelled and nonchannelled groups, respectively, showing the noninferiority of the channelled group (difference in proportions -0.8%; 95% confidence interval [CI], -4.8% to 2.9%; predefined noninferiority margin, -5%; P = 0.62). Fewer participants in the channelled group had subglottic injuries than in the nonchannelled group (32% [32/100] vs 57% [54/95]; difference in proportions, -25%; 95% CI, -39% to -11%; P < 0.001). There were no significant differences between the two groups in the overall intubation success rate, time to intubation, and incidence or severity of other intubation-related complications.
For videolaryngoscopic intubation in patients with a cervical collar, channelled Macintosh-type blades are an alternative to nonchannelled Macintosh-type blades, with a noninferior initial intubation success rate and a lower incidence of subglottic injury.
CRIS.nih.go.kr ( KCT0005186 ); first submitted 29 June 2020.
Shin KW
,Lee SP
,Kim T
,Choi S
,Kim YJ
,Park HP
,Oh H
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