Thoracic Surgery Clinical Trial
Official title:
A Comparison of Three Videolaryngoscopes for Double-Lumen Tubes Intubation in Humans. A Randomized Controlled Study
Introduction: Compared with the Macintosh laryngoscopy (MAC), the videolaryngoscopes (VL)
provide superior glottis views and longer times to double-lumen tube (DLT) intubation. We
hypothesize that the use of the King Vision™ (KVL) and the Airtraq® VLs may reduce the time
for DLT intubation compared with the Glidescope® (GVL) and MAC in patients undergoing
thoracic procedures.
Methods: One hundred-forty patients who will be scheduled for elective thoracic procedures
using the DLT for one-lung ventilation will be randomly assigned to one of four groups (n=35
per group) to intubate using the MAC, GVL, Airtraq®, or KVL. Time to DLT intubation, glottis
view, ease of intubation, number of optimization maneuvers, and failure to intubation (>150
s.) will be recorded.
Several regional surveys among thoracic anesthesiologists showed that the double-lumen
endobronchial tubes (DLT) is still the first choice for lung separation.[1-3] The
introduction of videolaryngoscopes (VL) enables the use of the DLTs instead of a bronchial
blockers for lung separation in patients with difficult airway.[4-5]
There are numerous VLs, including, stylets, channeled and traditional VLs. The
GlideScope®-assisted DLT insertion (Verathon Inc., Bothell, WA, USA), has been associated
with variable intubation durations according to the experience of the intubating operators,
despite superior vocal cord views.[6-7] The channeled VL, like as the Airtraq® (Prodol
Limited, Viscaya, Spain) and the standard non-channeled blade of the King Vision™ (KVL™)
(King Systems, Indianapolis, IN, USA), may offer additional benefits for DLT intubation in
patients with limited mouth opening or restricted neck movement, [8-10] in whom the use of
traditional VL like as the Glidescope® could be difficult. This is because of the larger
outer diameter, the distal curvature and the increased rigidity of the DLT.[11]
Of note, the longer intubation durations with the use of different VL-assisted DLT insertion
could be shortened with building up the operator's experience.
Comparing the effects of the three studied VLs on the time to DLT intubation in humans has
not yet been studied.
We hypothesize that time to successful DLT intubation using the channeled VL, namely, the
Airtraq® and KVL™, will be shorter than with the Macintosh (MAC) laryngoscope and
GlideScope® VL when used by non-expert anesthesiologists. We will compare the effects of the
MAC, GlideScope®, Airtraq® and KVL™ on the time to DLT intubation, laryngoscopic view, ease
of intubation, number of intubation attempts, and number of optimization maneuvers in
patients undergoing thoracic procedures using DLTs for one-lung ventilation (OLV).
Standard monitoring, and bispectral index (BIS), or state and response entropy based depth
of anesthesia, (GE Healthcare, Helsinki, Finland) will be applied to all patients.
Neuromuscular blockade will be measured with a train of four stimulation (TOF) of the ulnar
nerve. Invasive blood pressure monitoring will be achieved by cannulation of the radial
artery. After preoxygenation, general anesthesia will be induced with propofol 1.5 to 3mg
kg-1 and fentanyl 2-3 µg kg-1 or remifentanil 0.05-0.2 ug Kg-1 min-1, titrated to achieve a
BIS value < 60 or a state entropy values of less than 50 and a difference between response
and state entropy of less than 10. Rocuronium (0.6 mg kg-1) will be given to facilitate
intubation with an appropriate sized left-sided DLT.
In all groups, during the insertion of the DLT, exercise caution to avoid damage to the
tracheal cuff by the upper teeth during its passage through the mouth opening. After DLT
intubation, the tracheal cuff will be inflated and ventilation of the lungs commenced. Then,
the correct position of its tip will be confirmed with a fiberoptic bronchoscope.
The first intubation attempt will be considered a failure if the trachea is not successfully
intubated within 150 s or if the peripheral oxygen saturation (SpO2) decreases by 5%.
Following an initial tracheal intubation failure, the participants will be allowed to use
any maneuver and device they would normally use to navigate the DLT into the trachea.
Demographic data will be recorded including grade, experience with the VLs, and previous DLT
intubation experience with the VLs.
All data, with the exception of the difficulty of device use score, will be recorded by
blinded investigators.
A pilot study showed that the mean time to DLT intubation using the GlideScope® VL was 72
seconds with a standard deviation of 45.2 seconds. An a priori power analysis indicated that
a sample size of 32 participants was sufficiently large to detect a 50% difference in the
time to DLT intubation, during the use of the channeled VL, a type-I error of 0.008 (0.05/6
possible comparisons) and a power of 90%. We will add more patients (10%) for a final sample
size of 35 participants to compensate dropping out during the study.
Data will be tested for normality using Kolmogorov-Smirnov test. Categorical data will be
analyzed using the Fisher's exact test. Repeated-measures analysis of variance (ANOVA) will
be used for continuous parametric variables, and the differences will be corrected by the
post hoc Bonferroni test. Kruskal-Wallis test will be used for nonparametric values, and
post hoc pairwise comparisons will be performed using the Wilcoxon rank-sum t test
Continuous data will be presented as mean (standard deviation, SD), ordinal data will be
presented as median (inter-quartile range), and categorical data will be presented as number
(%). A value of p< 0.05 will be considered to be statistically significant.
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