Is Endotracheal Tube Use Mandatory in Patients Undergoing Nasal Septum Surgery? Randomized, Controlled, Prospective Clinical Trial
Phase: NA
Conditions: Airway Aspiration, Airway Complication of Anesthesia
Sponsor: Inonu University

28.11.2018 
Title page 
 
Is Endotracheal Tube Use Mandatory in Patients Undergoing Nasal Septum Surgery? 
Randomized, Controlled, Prospective Clinical Trial   
 
Erol Karaaslan, Asst. Prof. Department of Anesthesiology and Reanimation, Inonu University Medical 
Faculty, Malatya, Turkey 
Sedat Akbas, Asst. Prof. Department of Anesthesiology and Reanimation, Inonu University Medical 
Faculty, Malatya, Turkey 
Ahmet Selim Ozkan, Asst. Prof. Department of Anesthesiology and Reanimation, Inonu University 
Medical Faculty, Malatya, Turkey 
Zekine Begec, Prof. Department of Anesthesiology and Reanimation, Inonu University Medical 
Faculty, Malatya, Turkey 
 
 
Address all correspondence to: 
Erol Karaaslan, Asst. Prof. Department of Anesthesiology and Reanimation, Inonu University Medical 
Faculty, Malatya, Turkey 
Mail: erkara44@hotmail.com 
Phone Number: +905322034830 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

28.11.2018 
Protocol 
This study is approved in Malatya Clinical Research Ethics Committee with the protocol code of 2018-
165 and carried out at Department of Anesthesiology, Inonu University Medical Faculty in accordance 
with the criteria of Helsinki Agreement.  
 
The study is planned as a prospective, randomized clinical trial. For randomization, the patients will be 
assigned to the study groups entirely by chance, and selection bias was prevented. MedCalc for 
Windows, version-16 statistical software (medcalc.com.tr.) will be used. A total of 80 patients with 
elective nasal septum surgery will be randomly assigned to the groups of Supreme LMA (Group L, n = 
40) and ETT (Group E, n = 40). 
 
Patients who agreed to participate voluntarily were informed about the potential risks and predictable 
outcomes of the study. The study will be performed on 80 patients between 18-65 years old, American 
Society of Anesthesiologists (ASA) I-II group planned for effective nasal septum surgery. Preoperative 
anesthesia evaluation (I) higher than ASA II (II) Patients with severe respiratory, hepatic or renal 
dysfunction (IV) Patients with history of allergy to anesthesia medications (V) of neurology and 
psychiatry patients (VI) Body mass index (BMI) of 30 Patients with obstructive airway history (cervical 
spine pathology, modified Mallampati grade 4 or thyromental distance <65 mm, VIII) will be excluded 
from the study who had a high risk of regurgitation or aspiration.  
 
General anesthesia will be standardized for all patients. Patients who were taken to the operation room 
will be routinely given 3 minutes preoperative oxygenation. Vital finding parameters in supine position; 
Noninvasive blood pressure (NIBP), pulse oximetry (SpO2), heart rate (HR), monitoring will be 
performed. 
 
Anesthesia induction of both groups; remifentanil 3 μg.kg-1 IV will be performed with propofol 2.5 
mg.kg-1 IV and muscle relaxant will not be used. Intubation will be performed by the same 
anesthesiologist who experienced at least 5 years success rate of over 90% in orotracheal intubation and 
laryngeal mask placement after the patients had lost consciousness and chin looseness was formed 
sufficiently. 
After the third attempt, the cases in which endotracheal tube and Supreme LMA could not be placed 
correctly will be excluded from the study and airway safety will be ensured.  
In the maintenance of anesthesia, 1 MAC value will be used in desflurane 50% O2 / air mixture and 
remifentanil infusion (0.1 mcg / kg / min IV). In both groups, mechanical ventilation will be achieved 
with volume controlled ventilator mode (Dräger Primus ventilator, Dräger AG, Lübeck, Germany). 
Intraoperatively, 4 L / min of fresh gas flow will be adjusted to be 8 mL / kg tidal volume, and respiratory 
rate of 35-45 mm Hg EtCO2. 

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In Group L, LMA will be guided by the guideline: <50 kg, size 3; 50-70 kg, size 4; 70-100 kg, size5. In 
Group E; 8 male and 8 female patients will have endotracheal tube. In Group L, the intracuff pressure 
will be adjusted to 60 cm H2O and in Group E the cuff pressure will be adjusted to 20 H2O using a 
manometer (Portex Cufator Endotracheal Tube Manometer, Portex® Limited, Hythe, Kent, UK). The 
airway device will be then connected to the anesthetic circuit. The correct position of the tubes in both 
groups; the absence of leakage sound from the mouth, chest expansion during ventilation, capnography 
and auscultation will be confirmed. A nasogastric tube will be inserted into the LMA drainage tube. 
Air leakage to the stomach will be controlled by checking for bubbles (foam) at the proximal end of the 
nasogastric tube. Depth of anesthesia will be monitored with the bispectral index (BIS; VISTA 
Monitoring System, Massachusetts, USA) monitoring. Two cerebral NIRS and BIS sensors will be 
placed in the right and left frontal areas under the hairline and covered with tape to prevent exposure to 
light. 
 
Patients who opened their eyes with eye, breathing regularly, respiratory rate was 12-20 / min, oxygen 
saturation greater than 95% will be extubated and taken to the recovery room (PACU).  
 
Outcome Measures 
In Group L and E, oropharyngeal leak pressures will be measured while the head will be in neutral 
position. The flowmeter O2 current will be set at 3 L / min and the expiratory valve will be closed. When 
an investigator who did not know which type of airway device was placed, another researcher looked at 
the current pressure value from the aneroid manometer and confirmed that the pressure remained 
constant (pressure gauge stability test). This value was recorded as the value of oropharyngeal leakage 
pressure. To prevent lung exposure to barotrauma, the expiratory valve was opened when the peak 
inspiratory pressure reached 40 cmH2O, and the test will be terminated. 
 
At the end of the surgery, in Group L and E, the presence of blood will be observed through a tubular 
fiberoptic bronchoscope. Posterior oropharynx will be carefully aspirated at the end of surgery in 
patients with endotracheal tube. After extubation, presence of blood around ETT cuff and distal blood 
will be examined. In the presence of blood, a four-scale scale will be used at the level of glottis-trachea 
and distal trachea. (1 = no, 2 = mild, 3 = moderate, 4 = severe). Mean arterial pressure (MAP), heart rate 
(HR), and peripheral oxygen saturation (SpO2) immediately prior to anesthesia induction, 5, 15, 30, 45, 
60 after confirmation of airway placement 75. EtCO2 will be recorded per minute and every 15 minutes 
during the operation. Demographic data, duration of surgery and total anesthesia duration will be 
recorded. 
Orogastric tube placement; very easy, easy, difficult, very difficult in the form of a 4-point scale will be 
used. 

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Pharyngolaryngeal adverse events (laryngospasm, bronchospasm, nausea, vomiting, coughing, 
desaturation (SpO2 <94) and re-intubation need will be observed in the operation room and PACU at 5, 
15, 25 and 45 min. Sore throat, nausea, vomiting, dysphonia and dysphagia will be evaluated and 
recorded at 2, 4, 6, 12 and 24 hours postoperatively. Postoperative adverse effects will be evaluated as 
follows: laryngospasm; airway obstruction due to muscle rigidity in the chest and abdomen, 
Bronchospasm; especially during expiration, increased respiratory effort and wheezing. Dysphonia; 
difficulty in speech because of difficult speech or pain. Difficulty in swallowing; difficulty in 
swallowing or painful swallowing.  
Sore-throat; it was defined as constant pain felt independently of swallowing. The evaluation was made 
with 0 ile10 numerical pain rating scale (NRS: Numeric Rating Scala). According to NRS, sore throat 
score will be evaluated as; 0-1: none, 2-4: mild, 5-7: intermediate and 8-10: severe.  
5 point scale was used to determine the severity of nausea / vomiting. (0 = no nausea, 1 = mild nausea, 
2 = moderate nausea, 3 = vomiting less than 2 times per hour, 4 = vomiting more than 2 times per hour). 
Cough; cough in the postoperative period (less than 5 coughs will be ignored within the first minute 
after removal of the mask or tube, more than 5 coughs will be counted), 
Statistical Analyzes 
Type I error (alpha) 0.05, the power of the test (1-beta) 0.9, the primary output variable in the air (glottis 
/ trachea) for the amount of blood effect of 0.71 and the alternative hypothesis (H1) is two-way to be 
found a significant difference using this test A total of 80 patients were required, with a minimum sample 
size of 40 in each group (Kaplan A, Crosby GJ, Bhattacharyya N. Airway Protection and the Laryngeal Mask 
Airway in Sinus and Nasal Surgery. Laryngoscope 114: April 2004.)