Nasal Septum Deviation Clinical Trial
Official title:
A Comparison of the Face Mask and Oral Mask Ventilation After Nasal Surgery.
Difficult mask ventilation is usually studied in relation to airway management and difficult
intubation and mostly during the induction period of anesthesia.
According to the closed claim reports tracheal extubation and recovery of anesthesia is
associated with brain damage or death.
Difficult mask ventilation can also be a problem during the emergence phase of anesthesia
after extubation. Especially after nasal surgery the use of nasal tampon and casts can
resemble upper airway obstruction and facial deformity and cause difficult mask ventilation.
The effectiveness of ventilation is affected by the design of the mask. Leaks may develop
due to the inability to obtain a tight seal.
The use of an oral mask for ventilation in patients with nasal tumors and after rhinoplasty
for patients with a nasal cast has been reported. This suggests that oral mask ventilation,
rather than face mask ventilation, should be considered after nasal surgery.
The aim of this prospective randomized study is to compare the face mask and oral mask
ventilation after nasal surgery in terms of the mask ventilation classification, airway
pressure, minute ventilation and tidal volume.
Our hypothesis is that ventilation with oral mask would provide better airway pressures,
superior mask-ventilation classification and higher tidal volumes compared to face mask
ventilation in patients with obstructed nasal pasage (nasal packing and/or cast) after nasal
surgery'.
American Society of Anesthesiologists (ASA) physical class I or II, adult patients aging
19-45 yr, scheduled for nasal surgery will be recruited.
Patient characteristics will be recorded; age, gender ASA physical status, height, weight.
Simple randomization will be accomplished with a computer-generated sequence of numbers and
sealed envelopes will be used to allocate patients into 2 treatment sequences, Sequence O:
oral mask ventilation followed by face mask ventilation and Sequence FM: face mask
ventilation followed by oral mask ventilation.
Patients will be premedicated with midazolam. Ringer's lactate infusion at 15 mL•kg-1•h-1
will be initiated. Standard monitors will be established including neuromuscular
monitorization and the Bispectral index monitor (BIS).
The patients head will be placed in the neutral position on a positioning pad Anesthesia
will be induced with propofol 2 ml kg and fentanyl 50 mcg. Anesthesia will be maintained
with oxygen in nitrous oxide and sevoflurane. The patient was ventilated trough an face
mask. The appropriate size mask with the best fit will be selected and the mask size will be
noted. Gas flow will be 4 L min. During the induction period the mask ventilation grade of
the patients will be determined (Grade 0: ventilation by mask not attempted, Grade 1:
ventilated by mask, Grade 2: ventilated by mask with oral airway or other adjuvant, Grade 3:
difficult mask ventilation (inadequate, unstable, or requiring two practitioners), Grade 4:
unable to mask ventilate (Han's grading scale)) and patients with Grade ≥ 2 will be excluded
from the study. Muscle relaxation and intubation will be facilitated with rocuronium 0.6 mg
kg-1. At the end of surgery trachea will be extubated when TOF 0.9 is obtained and the
patient is spontaneous breathing, meanwhile inhalation anesthesia will be continued (BIS
50-70). After extubation, spontaneous ventilation will be assisted with mask ventilation.
Mask ventilation will be applied according to sequence allocation and the mask ventilation
grades with each mask technique will be determined with the same grading system. Spontaneous
ventilation will be assisted with mask ventilation.
The face mask will be applied with the one handed EC-clamp technique. The mask will be
placed over the bridge of the nose and mouth and a chin-lift, head tilt maneuver will be
used. The oral mask; size 1 or 2 child's mask will be placed only over the mouth and the one
handed EC-clamp technique with the chin-lift, head tilt maneuver will be used again. The
masks will be changed after three consecutive measurements for each mask technique and the
crossover time will be short.
The respiratory parameters will be measured with the monitor contained in the Drager Primus
anesthesia machine. The observer providing mask ventilation is experienced in mask
ventilation and will be blinded to the monitor display. All patients will be ventilated by
the same observer. Data will be recorded by independent residents. The mask ventilation
classification will be recorded. mean airway pressure (Pmean), maximum airway pressure
(Ppeak) , tidal volume (TV), expired tidal volume (TVe) minute volume leak (MVleak) and
minute volume (MV) will be recorded during spontaneous ventilation. Volatile anesthesia will
be ceased after observing that the patients are calm and not coughing and the respiratory
measures will be evaluated thereafter. The APL (airway pressure release) valve will be
closed during the evaluation of mask ventilation. Sufficient chest movement, mask leak,
gastric insufflations will be assessed. Indicators for difficult mask ventilation are
defined as; TV< 4 ml kg, inadequate chest movements, the need for an oropharyngeal airway,
two handed mask ventilation, need to increase the gas flow, gastric insufflations, need to
ventilate with two operators.
It was planned to enroll 30 patients in this study. After performing a pilot study we
calculated that 10 patients in each group was sufficient to detect a difference between
groups concerning tidal volume with 0.95 power and 0.05 alfa error. We decided to enroll 24
patients in the study due to possible drop outs.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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