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ORIGINAL ARTICLE
Ahead of print publication  

A randomised control study comparing C-MAC D-blade video laryngoscope (hyper angulated blade) and macintosh laryngoscope for insertion of a double-lumen tube in patients undergoing elective thoracotomy


1 Department of Anaesthesia, Christian Medical College, Vellore, Tamil Nadu, India
2 Department of Anaesthesia, Christian Fellowship Hospital, Oddanchatram, Tamil Nadu, India
3 Department of Biostatistics, Christian Medical College, Vellore, Tamil Nadu, India

Date of Submission03-May-2022
Date of Decision30-Jun-2022
Date of Acceptance04-Jul-2022
Date of Web Publication31-Oct-2022

Correspondence Address:
Raj Sahajanandan,
Department of Anaesthesia, Christian Medical College, Vellore - 632 004, Tamil Nadu
India
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/aer.aer_81_22

   Abstract 

Background: The use of a double-lumen endotracheal tube is one of the common anesthetic techniques for operations in the thoracic cavity. However, when compared to a single-lumen tube, placement of a double-lumen tube is technically more difficult as a result of which it takes more time to insert and is associated with more complications such as mucosal injury, hoarseness, and sore throat, even in patients with no anticipated airway difficulty. The CMAC D-blade that is usually used in patients with anticipated airway difficulty, could assist in smooth and quick placement of double-lumen tube (DLT) even in patients with no anticipated airway difficulty. Aim of the Study: This study aimed to evaluate the effectiveness of the C-MAC D-blade in reducing the time taken to visualize the glottis and intubate patients with normal airway with a double-lumen tube. Setting and Design: This was a prospective open-label randomized control trial in a tertiary hospital. Materials and Methods: Seventy-three consenting adult patients with physical status classes I and II, as determined by the American Society of Anesthesiologists, scheduled to undergo elective thoracotomy, were randomly allocated to receive either C-MAC D-blade (Group D) or Macintosh blade (Group M). The primary objective was to compare the time taken for visualization of the glottis and intubation. Statistical Analysis Used: Chi-square/Fisher's exact test and t-test were used for statistical analysis. Results: Seventy-three patients were randomized (Group D = 36; Group M = 37). Time to visualize the glottic structures (4.56 ± 2.396 s vs. 7.27 ± 4.891 s, P = 0.01) was significantly better in Group D; however, the mean intubation time was comparable (55.92 ± 18.749 s vs. 51.08 ± 15.269 s, P = 0.61). Conclusion: C-MAC D-blade videolaryngoscope offers a better glottic view and lesser time to visualize glottis when compared with the Macintosh laryngoscope. However, the time taken to insert the DLT after visualization was longer. We infer that there is no advantage in the routine use of C-MAC D-blade for DLT insertion in patients with no anticipated airway difficulty.

Keywords: Anesthesia, C-MAC D-blade videolaryngoscope, double-lumen tube, Macintos laryngoscope



How to cite this URL:
Mathew A, Mathai RR, Theodore B, Chandy J, Yadav B, Singh G, Sahajanandan R. A randomised control study comparing C-MAC D-blade video laryngoscope (hyper angulated blade) and macintosh laryngoscope for insertion of a double-lumen tube in patients undergoing elective thoracotomy. Anesth Essays Res [Epub ahead of print] [cited 2022 Dec 4]. Available from: https://www.aeronline.org/preprintarticle.asp?id=360090


   Introduction Top


Double-lumen tubes (DLTs) are the gold standard for lung isolation during operations in the thoracic cavity. However, they are longer and larger in diameter as compared to normal endotracheal tubes, which makes their insertion challenging. Complications such as mucosal injury, hoarseness, and sore throat are higher with DLT placement owing to decreased vision on insertion.[1] In the recent past, videolaryngoscopes have established their indisputable role either as a primary intubation device or as a rescue device in difficult airway algorithms.[2] Recent evidence, however, shows that it is not so with DLT placement and the results are conflicting. A study comparing conventional Macintosh versus C-MAC Macintosh (Mac 3) found that there was no significant difference in the time to intubate, but a reduced need for external laryngeal maneuvers (ELMs), better laryngoscopic grade, and less subjective force applied on the laryngoscope were the advantages seen with the C-MAC Macintosh blade.[3] The hyperangulated C-MAC® D-blade (Karl Storz, Tuttlingen, Germany), improves the ease of intubation owing to the increased field of vision in cases of extremely difficult airway.[4] The paucity of literature and inconsistency among the published studies using hyperangulated blades suggests that this area warrants more robust, well-conducted randomized controlled trials. We hypothesized that C-MAC D-blade videolaryngoscope would be superior to a conventional Macintosh laryngoscope for DLT placement in normal airway. The primary objective was to compare the time taken for visualization of the glottis and intubation. The secondary objectives were to compare the Intubation Difficulty Scale (IDS), first-attempt success, and complications associated with intubation.


   Materials and Methods Top


The study was conducted between May and August 2017 in the operating rooms of the department of thoracic surgery in a tertiary care teaching hospital on patients requiring lung isolation. The study was designed to be an open-label prospective randomized controlled clinical trial with block randomization. Recruitment commenced after institutional review board approval (IRB Min. No. 10550 dated February 15, 2017) and registration of the trial with the Clinical Trials Registry of India (CTRI) - REF/2017/08/015114. All eligible patients were recruited after obtaining written informed consent on the day prior to the operation. There were no changes made to the trial design or protocol during the course of the study.

Seventy-three consenting adults of American Society of Anesthesiologists (ASA) physical status (PS) classes I and II, between the ages of 18 and 70 years, with no anticipated difficult airway (El Ganzouri Risk Index ≤4), who were scheduled to receive left DLT, were recruited.[5] Pregnant patients, ASA PS classes III and IV patients, and patients with anticipated difficult airway (El Ganzouri Risk Index >4) were excluded.

Patients were randomly assigned to receive CMAC D-blade (Group D) or Macintosh (Group M). Permuted block randomization of size 2, 4, or 6 was used to generate the random sequence using SAS 9.1.3 software SAS (Statistical Analysis System),Cary, North Carolina, United States. This computer-generated randomization was placed in serially numbered, opaque, sealed envelopes in the operating theater. The sealed envelopes were opened, and the appropriate intervention was informed to the primary anesthesiologist before the induction of anesthesia by another anesthesiologist not involved in the study. The primary anesthesiologist could not be blinded to the laryngoscope used. Postoperative complications such as sore throat and hoarseness were evaluated by a staff nurse in the ward who was blinded to the primary intervention. The statistician analyzing the outcomes was blinded as well.

Interventions

A standardized anesthetic protocol was followed. All patients received ASA standard monitoring with invasive blood pressure monitoring. After preoxygenation (end-tidal EtO2 >90%), anesthesia was induced with intravenous (i.v.) injection of propofol (1.5 mg.kg−1) and fentanyl (2–3 μg.kg−1). Additional propofol boluses (maximum up to 3 mg.kg−1) were titrated to loss of verbal response. Tracheal intubation was facilitated by i.v. vecuronium (0.1 mg.kg−1). Intubation was carried out as per the randomization, either with the conventional Macintosh laryngoscope or with the CMAC D-blade laryngoscope using the appropriately sized DLT.

All participating anesthesiologists were trained for DLT insertion with both laryngoscopes, ten times each on TruCorp AirSim Bronchi mannequin (TruCorp© 2017, Ireland) and five times each in patients, prior to participation in the study. The selection of the DLT (Mallinckrodt Medical, Athlone, Ireland) was based on sex, height, and the left main bronchus diameter on computed tomography scan as per standard recommendations.[6]

The distal bronchial curve of the DLT was adjusted to match the shape of the laryngoscope with the stylet [Figure 1]. After laryngoscopy was performed with the allotted laryngoscope, and the glottis was visualized, the DLT with the stylet was introduced with the distal concavity facing anteriorly. Once the blue cuff was beyond the vocal cords, the stylet was removed, and the tube was rotated 90° counterclockwise and inserted until mild resistance was perceived.
Figure 1: Curvature of DLT obtained with the specified stylets of the different laryngoscopes (Macintosh, CMAC-Macintosh, and CMAC D-blade). DLT = Double-lumen tube

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It was stated in the study protocol that in the event of an unanticipated difficult airway, the patient would be excluded from the study and standard Difficult Airway Society guidelines would be followed.[2] In case of inability to intubate in the first attempt by the primary operator, another trained operator would perform the intubation.

Outcomes

The primary outcomes were the time taken for visualization of the glottis and the time for intubation. The time for visualization of the glottis was defined as the time from the introduction of the laryngoscope into the mouth until an optimal view of the glottis was obtained as decided by the intubating anesthesiologist. The time for intubation was defined as the time from the introduction of the laryngoscope into the mouth until three complete capnographic cycles were visualized on the monitor. This was measured by an independent observer, using the timer on the anesthesia monitor. The position of the DLT was confirmed with a fiber-optic bronchoscope for every case.

The subjective difficulty of intubation was measured using the IDS,[7] Cormack–Lehane (CL) grading, first-attempt success rate, the need for ELM, and other maneuvers as observed and documented by an independent observer.

Complications, such as esophageal intubation, airway trauma evidenced by blood on the laryngoscope blade, or obvious lacerations after intubation, were documented by the independent observer. Patients were also checked by the primary investigator for up to 3 postoperative days to assess for soreness of the throat and hoarseness of voice.

Sample size

The sample size was calculated to show a minimum difference of 10 s in the mean intubation time. This is considered clinically important when using CMAC D-blade as compared to Macintosh blade based on previous studies.[8] The calculated sample size was 40 in each group, with 80% power and 5% level of significance.

Statistical methods

Summary data were presented as mean (standard deviation) for continuous variables and as numbers and percentages for categorical variables. The characteristics of patients in Group D and Group M were compared using t-test for continuous data. Categorical data were compared using Chi-square/Fisher's exact test as appropriate. Statistical significance was defined as P < 0.05. All analyses were performed using SPSS version 25.


   Results Top


A total of 82 patients were screened, of which 9 patients were excluded as they did not meet the inclusion criteria or did not consent to participate in the study. Of the 73 consenting patients, 36 were assigned to Group D and 37 to Group M. The flow of participants is shown in the CONSORT diagram [Figure 2]. Four consultants and three trainees who were trained prior for the use of CMAC and DLT performed all the intubations. All patients received left DLT as part of the protocol. Both the groups were comparable in terms of demographic parameters such as age, sex, height, BMI, and baseline airway characteristics as classified by the El Ganzouri Index [Table 1].
Figure 2: CONSORT flow diagram

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Table 1: Baseline demographic parameters and El Ganzouri multivariate indicator for airway difficulty

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The outcome measures are summarized in [Table 2]. The mean time taken to visualize the glottis was significantly less in Group D as compared to Group M (4.56 ± 2.39 s vs. 7.27 ± 4.891 s, P = 0.01). However, the mean intubation time was comparable between Groups D and M (55.92 ± 18.749 s vs. 51.08 ± 15.269 s, P = 0.61).
Table 2: Comparison of outcome measures

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The first-attempt success rate was 83.3% (30/36 cases) in Group D, and 81.1% (30/37) in Group M, with no statistically significant difference (P = 0.689).

The use of the Macintosh blade was associated with a significantly higher incidence of poor laryngoscopic grade (64.9% vs. 94.4%, P = 0.007), the requirement of ELM (43.2% vs. 19.4%, P = 0.043), and difficulty of intubation as estimated by the IDS (3.39 vs. 2.86, P = 0.046) [Table 2].

The time taken to intubate can vary with the experience of the person who performs the intubation. The consultant anesthesiologists took less time to intubate, with either of the laryngoscopes than postgraduate trainees, but this difference was significant only with the CMAC D-blade. A subgroup analysis showed that the consultants took significantly less time to intubate with D-blade (41.6 ± 4.83 s vs. 48.36 ± , P = 0.047) compared to the trainees (61.42 ± 19.34 s vs. 52.23 ± 16.6 s, P = 0.043) [Table 3].
Table 3: Time to intubate and first-attempt success across operators of varied experience

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The incidence of soreness of throat and hoarseness was significantly less in Group D (11.1% vs. 27.9%, P = 0.045) as compared to Group M (5.6% vs. 21.6%, P = 0.047) [Table 4].
Table 4: Complications

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There was one case of esophageal intubation in Group M. None of the patients in either group had lacerations or blood on the laryngoscope blade. There were two instances of cuff tears in Group D. All the patients were intubated within two attempts.


   Discussion Top


The key findings of the study were that the time taken to visualize the glottis was less in patients who were intubated using the CMAC D-blade (Group D) compared to those intubated using a Macintosh blade (Group M). However, this did not eventually translate to a faster intubation time. There were fewer patients in Group D with poor laryngoscopic grade, high intubation difficulty scores, and requiring ELMs to assist in tube placement [Table 2].

Shah et al. compared the Macintosh and CMAC D-blade in the setting of onco-surgical patients and had similar intubation times (37.41 + 18.8 vs. 32.27 + 11.13).[9] However, all the intubations in their study were done by two experienced operators, whose intubation times were similar to the consultants in our study as per the subgroup analysis (CMAC D vs. Macintosh 41.6 ± 4.83 vs. 48.36 ± 11.75, P = 0.047). Shah et al. had significantly less first-attempt success (53% with Macintosh and 87% with CMAC D-blade) as compared to our study (81.1% with Macintosh and 83.3% with D-blade). Moreover, a majority of their failures requiring reintubation were associated with longer intubation times (more than 180 s) which can result in morbidity in this high-risk population. Unlike our study, they chose onco-surgical patients, where 20% of the patients were classified as having a difficult airway (5 patients in the Macintosh group and 6 patients in the D-blade group having El Ganzouri Index ≥4), accounting for a lower first-attempt success rate.

A similar observation in terms of time to intubate has been highlighted by Hsu et al. with the GlideScope as compared to the Macintosh, where two experienced consultants did all the intubations.[10]

Russell et al. compared the GlideScope and the Macintosh laryngoscope for DLT insertion with 30 anesthesiologists of varied experience, and observed that the time to intubate was longer with the GlideScope (70 s vs. 32 s). These observations are similar to those in our study where trainees took a significantly longer time to intubate with CMAC D-blade as compared to the Macintosh blade (61.42 ± 19.34 s vs. 52.23 ± 16.6 s, P = 0.043). It must be noted here that introduction and advancement of a DLT using an angulated blade is technically more difficult despite a better CL grade, especially for inexperienced operators.[11]

A recent meta-analysis by Liu et al.[12] showed that the first-attempt success rate was better with a videolaryngoscope compared to a Macintosh laryngoscope (92.6% vs. 82%, respectively). Subgroup analysis of their data revealed that this difference was more marked with experienced operators. However, for inexperienced operators, the first-attempt success was comparable between the two laryngoscope blades. These results are similar to our subgroup analysis, where the experienced operators had 100% success with the D-blade as compared to the Macintosh (90.9%), while the success rate was similar in the hands of trainees.

Both in the meta-analysis and in our study, the time taken to intubate was less with videolaryngoscopes where the operators had significant experience in the use of the videolaryngoscope for DLT insertion. This illustrates the importance of training in videolaryngoscopy to overcome the learning curve.[13] Studies have recommended that an anesthesiologist performs at least 5 intubations using a videolaryngoscope on a mannequin with DLT before participating in the study.[11] Sakles et al. observed progressive improvement in first-pass success of tracheal intubation with the GlideScope over a 7-year period.[13] Therefore, emphasis should be on simulated training of anesthesiologists in the use of videolaryngoscope for DLT intubation in both normal and difficult airways.

In their meta-analysis comparing different videolaryngoscopes for DLT insertion, Kim et al. found that the Macintosh laryngoscope was significantly better in terms of time to intubate.[14] Our study had similar results when trainees attempted intubations (61.42 ± 19.34 vs. 52.23 ± 16.6, P = 0.043), as once the three axes were aligned and the glottis visualized, the intubation with DLT was fast. However, the consultants who had significant experience with the use of D-blade, were able to perform DLT intubation significantly faster with it.

Videolaryngoscopes, theoretically, enable quick tube placement, as the wide viewing angle (80° in case of the CMAC D-blade) preempts the need to align the oral, laryngeal, pharyngeal axes of the airway.[15] Several review articles (El-Tahan and Liu et al.) have studied videolaryngoscopes as channeled, nonchanneled and video stylets, but none of the studies have focused on differences between the traditional Macintosh laryngoscope and hyperangulated blades.[16],[12] Different types of videolaryngoscope blades and hyperangulated blades have been combined together as standard videolaryngoscopes. We feel that while hyperangulated blades facilitate quick and easy visualization, introduction of the DLT into the trachea is difficult, as the hyperangulated DLT abuts the anterior tracheal wall [Figure 3]. The superior glottic view offered by the D-blade did not translate into faster intubation time. This is because the tip of the DLT is angulated to match the curve of the hyperangulated D-blade, which impinges in the subglottis, necessitating manipulations and resulting in increased intubation times. This is easily overcome by the withdrawal of the stylet by 0.5–1 cm behind the tip of DLT, which significantly reduces impingement in the subglottis. The removal of the hyperangulated stylet immediately after the blue cuff of the DLT passes the glottis, followed by a 90° counterclockwise rotation, facilitates smooth intubation [Figure 3]. Bustamante et al. described a successful maneuver of sequential rotation with the removal of the stylet after entering the glottis using a GlideScope.[17] We did not have any malposition which needed DLT repositioning. Our results are different from the meta-analysis by Kim et al. which showed significant malpositions with videolaryngoscopes. We did not do the 180° rotation as described by Bustamante et al., as a rotation of more than 90° increases the risk of intubation of the opposite side, necessitating repositioning under the guidance of a fiber-optic bronchoscope.[17]
Figure 3: X-ray showing the hyperangulated DLT abutting the anterior tracheal wall. DLT = Double-lumen tube

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Angadi and Frerk proposed that videolaryngoscopes and Macintosh laryngoscope should not be compared on the CL grade alone and the IDS should be used instead.[18] In our study, IDS was significantly less with the CMAC D-blade (2.86 vs. 3.59, P = 0.046) despite similar first-attempt success rate and intubation times. This is because the use of the D-blade resulted in better CL grades (94.4 vs. 64.9 CL1), with less lifting force, thus resulting in significantly less external laryngeal manipulations (19.4% vs. 43.2%). Our results were similar to Kim et al. who found that fewer external laryngeal manipulations were required when a videolaryngoscope was used.[14]

The incidence of sore throat and hoarseness was significantly less with the CMAC D-blade (11.1% vs. 27.9%). Our results are similar to those observed in the meta-analysis by Liu et al. and may be attributed to a magnified glottic view available on the monitor screen during intubation.[12] However, there is a subjective element to perception of sore throat and hoarseness, and the tube size is an important nonmodifiable factor.

Two cases in the CMAC D-blade had cuff tears. There are two possible explanations for this. First, the flange height of the CMAC D-blade is less (1.6 cm) as compared to the Macintosh laryngoscope (2.5 cm). Second, the anesthesiologist's attention may have been diverted away from the mouth to the screen during the initial manipulation of the tube, resulting in the cuff inadvertently impinging against the teeth. We corrected this immediately by re-emphasizing that the correct technique of video laryngoscopy which is described as (a) to look into the mouth during the introduction of the D-blade, (b) view the screen to obtain the desired view of the laryngeal inlet, (c) to look again into the mouth during initial introduction of the tube till the tracheal cuff passes the teeth, (d) to increase the lifting force to reoptimize the view and intubate. Adherence to this technique helped us to keep the incidence of airway injuries and DLT cuff damage to a minimum in our study.[19]

The limitations of our study were that first, it was impossible to blind the anesthesiologist to the type of laryngoscope being used, and this could have introduced bias.

Second, the level of difficulty of insertion of the DLT was assessed using the IDS, which included the subjective feel of lifting force required or the need for external laryngeal manipulations; all of these are operator dependent.

Third, we did not use Percentage of Glottic Opening Score to grade the laryngoscopic view, which is more relevant for videolaryngoscopes.[20]


   Conclusion Top


The CMAC D-blade videolaryngoscope resulted in a shorter time to visualize the glottis, with a significantly better glottic view, superior IDS score, and reduction in sore throat and hoarseness. However, this did not translate to a faster intubation time or a better first-attempt success rate in our study. We conclude that there is no advantage in the routine use of CMAC D-blade for DLT insertion in patients with no anticipated airway difficulty, especially in resource-poor settings.

Acknowledgment

We would like to thank all the supporting technical staff, the department of anesthesia, and our patients who made this study possible.

Financial support and sponsorship

This study was financially supported by the Research Fund of Christian Medical College, Vellore.

Conflicts of interest

There are no conflicts of interest.



 
   References Top

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    Figures

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