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Prospective Trial to Compare Direct and Indirect Laryngoscopy Using C-MAC PM® with Macintosh Blade and D-Blade® in a Simulated Difficult Airway
1Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Theodor-Stern Kai 7, 60590 Frankfurt, Germany
2Main-Kinzig-Clinic, Department of Anesthesia, Intensive Care Medicine and Pain Therapy, Herzbachweg 14, 63571 Gelnhausen, Germany
3Clinic of Anesthesiology, Intensive Care and Pain Therapy, Orthopedic Clinic Friedrichsheim, Marienburgstraße 2, 60528 Frankfurt am Main, Germany
4Evangelical Hospital Oldenburg, Department of Anesthesia, Intensive Care Medicine and Pain Therapy, Steinweg 13-17, 26122 Oldenburg, GermanyCorrespondence should be addressed to ; ed.ugk@nnamiar.nairolf
Received 3 November 2018; Revised 25 January 2019; Accepted 6 March 2019; Published 1 April 2019
Academic Editor: Selim Suner
Copyright © 2019 Florian Jürgen Raimann et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
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Objective. Evaluation of C-MAC PM® in combination with a standard Macintosh blade size 3 in direct and indirect laryngoscopy and D-Blade® in indirect laryngoscopy in a simulated difficult airway. Primary outcome was defined as the best view of the glottic structures. Secondary endpoints were subjective evaluation and assessment of the intubation process. Methods. Prospective monocentric, observational study on 48 adult patients without predictors for difficult laryngoscopy/tracheal intubation undergoing orthopedic surgery. Every participant preoperatively received a cervical collar to simulate a difficult airway. Direct and indirect laryngoscopy w/o the BURP maneuver with a standard Macintosh blade and indirect laryngoscopy w/o the BURP maneuver using D-Blade® were performed to evaluate if blade geometry and the BURP maneuver improve the glottic view as measured by the Cormack-Lehane score. Results. Using a C-MAC PM® laryngoscope, D-Blade® yielded improved glottic views compared with the Macintosh blade used with either the direct or indirect technique. Changing from direct laryngoscopy using a Macintosh blade to indirect videolaryngoscopy using C-MAC PM® with D-Blade® improved the Cormack-Lehane score from IIb, III, or IV to I or II in 31 cases. Conclusion. The combination of C-MAC PM® and D-Blade® significantly enhances the view of the glottis compared to direct laryngoscopy with a Macintosh blade in patients with a simulated difficult airway. Trial Registration Number. This trial is registered under number NCT03403946.
1. Introduction
Patients with an unexpectedly difficult airway requiring endotracheal intubation (ETI) remain extremely challenging for emergency physicians, and intubation failure with subsequent hypoxic complications still represents the majority of cases in a closed claim analysis [1].
The incidence of major complications in airway management of 1 in 5,500 was estimated in the Fourth National Audit Project in the UK [2].
Particularly in the prehospital setting, an increased incidence of a difficult airway up to 14.8% is described [3]. Cervical spine immobilization in trauma patients with a collar is common. Cervical collars lead to a reduced reclination of the head and in a reduced interincisor distance. This can make direct visualization of the glottis challenging and the incidence of a difficult airway increases up to 64% [4].
In the last decade, the use of videolaryngoscopes for endotracheal intubation has become routine in the clinical setting, especially in (unexpected) difficult airway management [5–7]. Videolaryngoscopy (VL) eliminates the need for a direct line of sight between the operator and glottis. The potential benefit of VL in difficult airway management is highlighted in different international guidelines [8, 9] and is the subject of a Cochrane analysis [10].
Many different types of VL have been developed in the last years [11] and their application in the clinical setting has been published [12, 13]. In particular, hyperangulated blades have been developed for visibility improvement, although good visibility is not automatically associated with an easy intubation process [14]. For example, D-Blade® with its hyperangulated tip allows a good visualization of the glottis structures in patients with normal and difficult airways [13]. Therefore, only indirect laryngoscopy is possible, requiring an external monitor like C-MAC® or C-MAC PM® [15, 16]. One benefit of the C-MAC PM® system is its compact design. By plugging the monitor directly onto the handle, no additional cables or external power supply is required. This has potential advantages especially in the prehospital setting.
We hypothesize that using C-MAC PM® in combination with D-Blade® improves the view of glottic structures in patients with a simulated difficult airway. Our aim was to compare intubation conditions regarding the modified Cormack-Lehane score (CL) [17] between D-Blade® in indirect laryngoscopy or a Macintosh blade in direct and indirect laryngoscopy with C-MAC PM® in a simulated setting of a difficult airway in human subjects. To obtain optimal comparability of the visualization three laryngoscopies with different approaches were performed in one patient.
2. Materials and Methods
2.1. Study Design
This prospective, single-center study was conducted at the University Hospital Frankfurt, Germany. After approval of the study protocol by the Institutional Ethical Review Board (reference number: E 126/11) the study was carried out in accordance with the Declaration of Helsinki. This study is registered at clinicaltrials.gov (NCT03403946).
2.2. Population
Patients requiring general anesthesia for orthopedic surgery were included. Written informed consent was obtained from all participants.
Patients aged <18 or >80 years with a known or expected difficult airway, undergoing urgent or emergent surgery, nonfasted, of American Society of Anesthesiology (ASA) Classes IV-VI, or without consent to participation were excluded from the study.
Preoperative airway evaluation was carried out by assessing the Mallampati score, thyromental distance, cervical spine clearance, and interincisor distance. Difficulty was defined as a Mallampati score III or IV, thyromental distance of <6.5 cm, reclination of <30°, an interincisor distance of <3 cm, presence of a full beard, toothlessness, or a known obstructive sleep apnea syndrome.
2.3. Setting
In the operating room, routine monitoring was applied (noninvasive blood pressure, heart rate, and pulse oximetry). Prior to the induction of anesthesia, all patients received a size-adapted cervical collar (Stifneck-Regular®, Laerdal Medical GmbH, Puchheim, Germany) fitted according to the manufacturer’s instructions. Interincisor distance, cervical reclination, and the Mallampati score were obtained after collar placement (Table 2).
The cervical collar was then removed, and the patient was then preoxygenated (FiO2 = 1.0) for three minutes. Induction of anesthesia was performed intravenously with 2 mg/kg propofol (Fresenius Kabi, Bad Homburg, Germany) and 2 μg/kg fentanyl (Rotexmedica, Luitré, France) in all patients. Neuromuscular blockade was achieved with intravenous 0.6 mg/kg rocuronium (Inresa, Freiburg, Germany). After two to three minutes and absence of spontaneous breathing, the cervical collar was placed again, and laryngoscopy was performed in all participants in the following manner (Figure 2, supplementary online material).
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First, direct laryngoscopy was performed using a Macintosh blade size 3 with an attached C-MAC PM® monitor (Karl Storz GmbH & Co. KG, Tuttlingen, Germany) with and without applying external laryngeal pressure (the BURP (Backward, Upward, Rightward Pressure) maneuver). To perform direct laryngoscopy, the attached monitor was flipped over. In a second step, view on the monitor for indirect laryngoscopy was allowed and evaluation was performed with and without BURP using the same blade size (Figure 1). The same procedure for indirect laryngoscopy was repeated using an adult D-Blade® (Karl Storz GmbH & Co. KG, Tuttlingen, Germany) and the patient’s trachea was finally intubated. We used a size 7.0 tube to intubate the trachea of female patients and a size 8.0 one to intubate the trachea of male patients. The allowed time for the entire examination was limited to 120 seconds. In the case of desaturation (SpO2 < 92%), the examination was interrupted and reoxygenation with bag-mask ventilation was performed until SpO2 ≥ 98% was achieved. In case of insufficient bag-mask ventilation, the cervical collar was removed. After reoxygenation, the collar was placed again, and the procedure was continued.
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