This is to document the harm endotracheal tubes and endotracheal tube (ETT) pilot balloons can cause patients, even after short surgeries, and the need for new standards of care in anesthesia. The new standards that are needed are:
1. Check and document cuff pressure with each and every intubation.
2. Base endotracheal tube sizing on the diameter of the patient’s trachea, not “routine” practice. This will result in the use of a size 6.0 or 6.5 for women.
Although marketed as “low”
pressure, the ETT is easily converted to a “high” pressure cuff if the pilot
balloon is over-inflated. This
manual over-inflation can generate pressures against the tracheal wall that
exceed 120 cm H2O pressure.
Since tracheal perfusion pressure is around 30 cm1, anything
above this places the patient at risk of tracheal ischemia, recurrent laryngeal
nerve damage and subglottic stenosis (SGS)2. Similarly, if an endotracheal tube that
is too large is used, the same complications are possible3.
Routine practice today is to
inflate the pilot balloon by the injection and palpation method. All research shows that this technique
is ineffective and results in the majority of pressures being too high. Currently, there are no standards in
anesthesia that regulate inflation technique of the pilot balloon. Without regulation, anesthesia
providers inject as much air as they want, resulting in pressures that can
exceed 120 cm H2O pressure. (A standard manometer only goes to 120 so it is impossible
to discern
the true pressures ― they could exceed
300!) Since tracheal perfusion
pressure is around 30 cm H2O, anything above this may cause tracheal
ischemia, tracheal necrosis, recurrent laryngeal damage, and, ultimately,
subglottic stenosis. All studies
show this damage may begin within 15 minutes of high pressure, and not only
with the prolonged intubation as historically thought4, 5, 6.
A second routine practice is
to use a size 7.0 ETT for women.
There is no research to support this practice. The true size of the 7.0 ETT is the outer diameter of 9.5
mm. Basic anatomy demonstrates the
diameter of some women’s tracheas could be as small as 6.6 mm to 8.0 mm7. Inserting a size 7 (inner diameter) ETT
in a small trachea and then using the injection and palpation technique of cuff
inflation could result in the damage to the trachea that leads to subglottic
stenosis.
Patients with post-intubation
SGS are usually misdiagnosed and incorrectly
treated for years prior to receiving the correct diagnosis. They are usually first diagnosed with
gastric reflux and then with asthma.
Some patients are even given the diagnosis of “panic attacks” when they
show up in emergency rooms struggling to breathe. When the correct diagnosis is finally made, a review of
their history is done, the intubation is dismissed as having been “too long ago”
to be the causative factor, and the patient is labeled idiopathic. All research, however, points to the
intubation as the most probable cause.
The symptoms were there for years; the patient was just
misdiagnosed. Dikkers correlated
the development of SGS to an intubation that occurred 20 years before12.
The accompanying letter is
from a patient who developed SGS post-intubation, and it is typical of the
timeline of this complication. She
says:
I am a 40 year old attorney, wife and mother from
Wausau, Wisconsin. I had a 35 minute intubation for a minor surgery in
2004. I was 5'5" and weighed 130 pounds. My anesthesia records
indicate that a size 7 tube was used and that cuff pressures were not
monitored. When I woke up I remember coughing very hard and I had a sore
throat.
I began having symptoms of wheezing and shortness of
breath with exertion in 2008. I
was misdiagnosed as having asthma for several years. I was short of breath
walking up stairs and had an audible wheeze during conversation. By the time I was finally diagnosed in
February, 2011, my airway was reduced to the size of a McDonald’s straw. In the
two years since my diagnosis I underwent three dilatation surgeries to open my
airway. I was told that I would
continue to need these dilatations every 6-12 months for the rest of my life and
that I had a 50% likelihood of needing a tracheostomy during my lifetime. I underwent a tracheal resection
surgery in March 2013 at which time three tracheal rings including my cricoid
were removed
The cost of this condition is tremendous. My
medical expenses were approximately $215,000. In addition, I had to pay
for the travel expenses of traveling from Wisconsin to Boston three times. I missed 13 weeks of work. This does not include the emotional
toll this condition has had on me13. This could have been prevented by simply checking the pressure
and using a smaller tube.
Every day that routine
practices are allowed to continue is another day patients are exposed to harm
from high cuff pressures and large ETTs.
If you care to read about the real damage that has been done to these
patients’ lives, you can read the communications from the online SGS support
groups. I cannot imagine how any
organization could ignore the suffering documented there. The financial, emotional and physical
toll on patients from the stenosis and its treatment is unimaginable.
Again, to protect patients
from harm, two new standards need to be adopted:
1. Check and document cuff pressure with each and every intubation.
2. Base endotracheal tube
sizing on the diameter of the trachea, not “routine” practice. This will result
in the use of a size 6.0 or 6.5 for women.
Just as we pad and protect the extremities and
nerves with each and every surgery, we must also protect the trachea. Please help keep patients safe and free
of preventable harm from routine endotracheal intubations.
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