Decongestants for dilating the nasal cavity, a randomised, blinded, prospective study to prevent iatrogenic epistaxis during nasotracheal intubation

Nasotracheal intubation is a frequently employed intubation technique for
dental and ear nose and throat surgical procedures, but bears the risk for
damage to nasal and pharyngeal mucosa. Passage of the tube through the nasal
cavity may lacerate of the mucosa, dislocate conchae and even create a fausse
route. The most common complication after nasotracheal intubation is epistaxis,
which complicates intubation as well as the operation itself because of loss of
visability. Importantly, nasal trauma may also lead to considerable patient
discomfort.

During the past 15 years, various methods, such as different tubes, guidewires
or decongestiva and lubricants have been suggested in order to prevent trauma.
Various studies assessed these methods to prove their efficacy. Many kinds of
tubes have been evaluated: a more flexible tube, side-beveled tubes and warming
the tube. The silicone tipped endotracheal tube seemed to be better in terms of
navigability and less peri-operative nasal injury. Intranasal xylomethazoline
0,1% drops and lidocaine 2% jelly has been proved to reduce the incidence and
severity of epistaxis after nasotracheal intubation in preschool children.
Others found that the use of esophageal stethoscope-obturated ETT*s was
effective, and comparable to thermosoftening, in preventing epistaxis
associated with nasotracheal intubation. Despite all the above-mentioned
preventive measures, trauma to the nasopharyngeal mucosa during nasal
intubation is still common and in particular epistaxis is estimated to occur in
17-80% of the nasal intubations.

Primary Objective:

The purpose of this study is to investigate the clinical efficacy of
xylomethazoline, combined with dilating the nasal passage way with a
polyvinyl-alcohol nasal dilator in the prevention of iatrogenic epistaxis
during nasotracheal intubation.

Secondary Objective:

To investigate the clinical efficacy of xylomethazoline with a
polyvinyl-alcohol nasal dilator to facilitate the nasal passage way of the
nasotracheal tube during nasal intubation.

This study is a randomized controlled trial with non-invasive measurements. The
study will be performed in the Catharina Hospital Eindhoven. Adult patients
requiring nasal intubation are eligible and will be asked to participate in
this study.
Patients will receive either a nasal decongestant (xylomethazoline) combined
with a polyvinyl-alcohol nasal dilator 60 minutes before nasal intubation and
xylomethazoline 5 minutes before the intubation (intervention group), or only a
nasal decongestant xylomethazoline 5 minutes before the intubation (control
group). The intubator will score the intubation characteristics and the
severity of an eventual epistaxis and eventual nasal complications will be
graded. The study will end after discharge from the postoperative anesthesia
care unit.

Patients will receive either a nasal decongestant (xylomethazoline) combined
with a polyvinyl-alcohol nasal dilator 60 minutes before nasal intubation and
xylomethazoline 5 minutes before the intubation(intervention group)

Nasotracheal intubation is a frequently employed intubation technique, but
passage of the tube through the nasal cavity may cause iatrogenic trauma. This
iatrogenic trauma may complicate airway management as well as the operation
itself. Furthermore, the procedure the patient may experience discomfort,
epistaxis and nasal pain.
Patients in the intervention group will receive 60 minutes before the planned
surgery xylomethazoline intranasally followed by a polyvinyl-alcohol (PVA)
nasal dressing (Merocel®) in both nostrils. Anesthesia will be induced
according to current standard of care. Xylomethazoline is current standard of
care during nasotracheal intubation, and discomfort due to the nasal dilator
will be minimal. The burden for the subject is very low and is in proportion,
and justifies the proposed study. The intervention is possibly beneficial for
the subject by reducing the risk for epistaxis and mucosal trauma.