Usage of a semi-rigid intubation endoscope is not superior to a video laryngoscope. A prospective, randomised, controlled trial comparing the SensaScope vs. the McGrath Series 5 in surgical patients

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Highlights

  • The Success rates using a video laryngoscopy vary considerably, and there is a high Proportion of patients in whom the glottic opening can be visualised but the endotracheal tube cannot be inserted into the trachea. The SensaScope enable better manoeuvrability, a superior view of the glottis and a shorter intubation time compared with a rigid video stylet.

  • This trial aims to determine whether a semi-rigid Intubation endoscope (SensaScope™) with a steerable flexible tip and an S-formed shaft was superior to the video laryngoscopy (McGrath™ Series 5) in elective surgery patients.

  • The study was to include 76 patients in this monocentre, open-label, randomised controlled superiority study.

  • Time to place was significantly shorter and the first-pass intubation success rate was higher when using the video laryngoscope.

Abstract

Introduction

Numerous guidelines and techniques have been developed to manage difficult airways and to prevent problems in airway management. To achieve an optimal view of the glottis, various video laryngoscopes and video stylets have been developed and introduced in clinical anaesthesia. The aim of this study was to compare the time to place the tracheal tube (TT) with the McGrath™ Series 5 (McG; Medtronic Dublin, Ireland) and the semi-rigid intubation endoscope SensaScope™ (Sc; Acutronic Medical Systems AG, Hirzel, Switzerland) in elective surgery patients.

Methods

With the approval of the local ethics committee, patients were recruited for this prospective, randomised clinical study. Exclusion criteria were age <18 years, emergency surgery and the presence of defined predictors for an expected difficult airway. Time to place the TT was the primary endpoint. Secondary endpoints were time to glottis view, time to first ventilation and the first-pass intubation success rate. Data are shown as medians and interquartile ranges [IQRs].

Results

In this study, we compared the McG and the Sc in 76 patients (McG n = 38; Sc n = 38). Time to place was shorter when using the McG, 14 s [12–22 s], than when using the Sc, 22 s [16–32 s] (p = .003). Time to glottis view was likewise shorter with the McG, 3 s [2–4 s], than with the Sc, 10 s [7–23 s] (p < .001). Time to first ventilation was longer with the Sc, 32.6 s [26–41 s], than with the McG, 25 s [19–29 s] (p < .001). Tracheal intubation was more successful with the McG, with success in 38/38 patients (100%) compared to 33/38 (86%) patients with the Sc on the first attempt (p = .02).

Conclusion

The tracheal intubation was significantly shorter using the video laryngoscope McG. The reasons for these results could be the presence of a large tissue mass at the level of the tongue base that interferes with the exposure of the glottis and the insertion of the TT using the Sc such that getting into the glottic aperture is aggravated.

Clinical trial registration

NCT02348736.

Section snippets

Background

Patient safety has improved through the development of airway management devices and techniques in the last recent years [[1], [2], [3], [4]]. Recognition of the limitations of direct laryngoscopy has led to the development of intubating devices that do not require a aligning of the oral, pharyngeal and laryngeal axes.

We studied two such non-traditional laryngoscopy techniques: The McGrath Series 5™ (McG; Medtronic®, Dublin, Ireland) is one of the first fully transportable video laryngoscopes

Research ethics approval

The ethics committee of the Medical Association of the State of Rhineland Palatine (Germany) approved this trial (Registration Nr.: 837.330.14 (9569)). This study is registered with ClinicalTrial.gov register number NCT02348736. Written informed consent was obtained from all patients at least one day before randomisation. Patients were randomised to a treatment group using the GraphPad QuickCalcs Web site: http://www.graphpad.com/quickcalcs/randmenu (accessed January 2015). After sample size

Results

From March to May 2015, a total of 76 (McG n = 38; Sc n = 38) adult patients eligible to participate in this study were included (Fig. 2). Intubations with the McG and the Sc were similarly distributed among the patients (p = .9). The patients in the McG group were younger, 34 years [27–56 y], than those in the Sc group, 53.5 years [33.5–63 y] (p = .01). All other patient characteristics were similar (Table 1; p > .05). The distribution of the applications were equal in both groups (McG;

Discussion

In the present study, a faster overall intubation time and a higher first-pass intubation success rate using a video laryngoscope blade (McG) were found in a group of 76 patients. The semi-rigid fibre-optic scope (Sc) did not have any advantages compared to the video laryngoscope (McG). In this trial, visualisation of the glottis and subjective assessment were comparable between the groups. Thus far, this study is one of the first studies comparing the video laryngoscopy with the semi-rigid

Conclusion

To conclude, use of the McG resulted in a significantly faster intubation time and fewer intubation attempts than use of the Sc. Video laryngoscopes in general may offer promise for intubation of the expected normal airway. The use of a semi-rigid fibre-optic does not optimise the tube advancement of anaesthesiologists in a controlled environment. Further studies to compare different video-based laryngoscope blade designs used in patients with different types of airway problems will be useful

Ethical approval and consent to participate

The local Ethical Committee of the Medical Association of the Rhineland Palatine State (Germany, Chairperson: Andrea Wagner, MD; 837.330.14 (9569)) approved this prospective, randomised clinical study (Clinical Trial Register Nr.: NCT02348736). Each patient was given detailed information and provided written informed consent before being included in the study.

Consent to publish

Not applicable. This manuscript does not contain any data on individuals.

Availability of data and materials

The dataset (Microsoft Excel Table; Additional file 1) that

Acknowledgements

The authors wish to thank Irene Schmidtman (Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Centre of the Johannes Gutenberg-University, Mainz, Germany). The manuscript contains parts of the doctoral dissertation of Johanna Strauβ, University Medical Centre of the Johannes Gutenberg-University, Mainz, Germany.

References (40)

  • G.N. Peterson et al.

    Management of the difficult airway: a closed claims analysis

    Anesthesiology

    (2005)
  • J.T. Mulcaster et al.

    Laryngoscopic intubation: learning and performance

    Anesthesiology

    (2003)
  • K. Ruetzler et al.

    Comparison of five video laryngoscopes and conventional direct laryngoscopy : investigations on simple and simulated difficult airways on the intubation trainer

    Anaesthesist

    (2015)
  • R.R. Noppens et al.

    Evaluation of the McGrath Series 5 videolaryngoscope after failed direct laryngoscopy

    Anaesthesia

    (2010)
  • B. Shippey et al.

    Case series: the McGrath videolaryngoscope–an initial clinical evaluation

    Can. J. Anesth.

    (2007)
  • M. Sargin et al.

    Comparison of McGrath Series 5 video laryngoscope with Macintosh laryngoscope: a prospective, randomised trial in patients with normal airways

    Pak. J. Med. Sci.

    (2016)
  • R. Maassen et al.

    The videolaryngoscope is less traumatic than the classic laryngoscope for a difficult airway in an obese patient

    J. Anesth.

    (2009)
  • A. van Zundert et al.

    A Macintosh laryngoscope blade for videolaryngoscopy reduces stylet use in patients with normal airways

    Anesth. Analg.

    (2009)
  • A.I. Levine et al.

    Flexible bronchoscopy still the definitive standard for airway management

    Anesthesiology

    (2013)
  • J. Redmond et al.

    Rigid bronchoscopic management of complications related to endobronchial stents after lung transplantation

    Ann. Otol. Rhinol. Laryngol.

    (2013)
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