Intubation Clinical Trial
Official title:
Comparison of Flex-It Stylet to Malleable Stylet for GlideScope Intubation: A Randomized Controlled Trial
Patients presenting for elective surgery requiring tracheal intubation will be randomized to
one of two different ETT stylets. The primary outcome is time to intubation.
The null hypothesis is that there will be no difference.
The GlideScope video laryngoscope (Verathon) is a widely used intubating device that uses a
high-resolution camera embedded into a plastic laryngoscope blade. An LED provides
illumination. The GlideScope often provides a good laryngoscopic view, but passing the
endotracheal tube (ETT) through the vocal cords is sometimes difficult. Because of the 60
degree anterior curvature of the GlideScope's blade, ETT's must have stylets inserted so
that the ETT distal tip can be positioned anteriorly. Various authors have recommended
different angles of the ETT to optimally place it into the trachea, including matching the
GlideScope's 60 degree angle, or configuring the ETT with a 90 degree bend. Previous studies
demonstrated that 90 degree sharp bend was both faster and subjectively easier in a
heterogeneous group of intubators. With the introduction of the Flex-It stylet by Parker
Medical, the question arises as to the the best configuration of stylet for the ETT.
Therefore, this prospective, randomized, single-blinded trial is proposed.
Written informed consent will be obtained by one of the study investigators, and a copy will
be given to each participant. Written informed consent will also be obtained from the
operator of the GlideScope. Envelopes with computer-generated randomized group assignments
will be present at each site. The envelopes will be consecutively numbered (i.e. "U1", "U2"
for University Hospital, "S1", "S2" for St Joseph's Health Care, etc.). After consent,
randomization will occur by selecting the next consecutive envelope. The envelope will
contain the data collection form as well as a piece of paper that has the following
information:
- at the top will be the randomization group (A, B) and a text description of the
endotracheal tube angle and stylet (i.e. "90 degrees - malleable stylet")
- in the body of the piece of paper will be a template that shows the exact shape into
which the tube must be bent, including where the distal and proximal ends are, the
angle of curvature that must be followed, and the location along the length of the tube
at which to create this angle. The angle and location will be the same for both males
and females.
There are three distinct anesthesia providers involved in the conduct of this study, as
follows:
1. "operator" - person performing the intubation
2. "timer" - person timing the outcome (one of the co-investigators)
3. "shaper" - person who ensures that the angle and stylet of the tube matches the group
to which the patient was allocated
Because the person intubating must be blind up until the time at which the tube is to be
used, the unopened envelope will be taken to a third anesthesia provider, who will prepare
the ETT with stylet in an area that is not visible to the person performing the intubation
or to the person timing the intubation. The person performing the intubation will specify
what size of tube to be prepared. This will most commonly be 7.5 mm internal diameter (ID)
for a female and 8.0 ID for males, but the operator is free to use whatever size they feel
is appropriate. The tube size selection will take place before unblinding so the group
allocation cannot affect the decision of tube size.
The tubes will all be cut at the 27 cm marking. "Group A" ETT's will be shaped with the aid
of a standard malleable stylet (Rusch 14 Fr) that has been lubricated with single-use
water-soluble lubricant. "Group B" ETT's will be instrumented with the Flex-It Stylet, with
identical lubricant. The prepared tube will then be concealed under a standard green OR
towel and brought to the operating room (OR). This tube will be placed close to the
patient's head so that it is readily accessible.
Data Collection
In the OR, the GlideScope will be turned on at least 60 seconds before use so that the lens
can warm-up to prevent fogging. The patient will be cared for in the usual fashion with
respect to monitoring and induction of general anesthesia. To ensure adequate
pre-oxygenation, the patient's end-tidal oxygen must be ≥ 70%. Muscle relaxation will be
used, and the agent used is at the discretion of the operator. After induction of
anesthesia, bag-mask ventilation will be used in the usual fashion until the operator
decides to proceed to laryngoscopy with the GlideScope. The operator will remain blinded to
the group allocation until after the laryngoscopic view has been obtained with the
GlideScope, where upon he will be handed the endotracheal tube.
The timer (who cannot see the tube under the green towel) will watch the operator until the
GlideScope is inserted into the patient's mouth, start the timer, and then turn 180º to face
the anesthetic monitor. The timer will not be able to see the ETT, stylet, or curvature
because he will be facing the monitor screen.
Timing will continue until end-tidal CO2 of at least 30 mmHg is seen on the anesthesia
monitor, at which point the data collection form will be filled out, and the study protocol
will be finished. (The time to intubation will be recorded to the nearest tenth of a
second.) If the operator fails to intubate within 3 attempts or 150 seconds, the intubation
will be noted as a failure, and the ultimately successful means of securing the airway will
be recorded.
The definition of an "attempt" for the purposes of this clinical trial are as follows:
1. anytime the GlideScope blade is removed from the patients mouth and then re-inserted
2. anytime the endotracheal tube is re-shaped (regardless of whether or not the GlideScope
is actually removed from the patient's mouth
3. if substantial adjustments are made to the patient's position (such as head position,
neck flexion, or neck extension). Small movements that would occur in the normal
process of intubation would not count as "substantial".
If oxygen desaturation (as recorded by pulse oximetry) below 95% occurs, then the patient
will be ventilated in the usual fashion to ensure oxygenation, and re-attempting intubation
using the GlideScope may proceed, but the timing will continue, and the same limits to
successful intubation (within 3 attempts or total of 150s) will apply. Between attempts, the
tube may be re-shaped by the operator if the operator feels that another curvature would be
preferred.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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