Comparison of the Effects of High-flow Nasal Cannula Oxygen and Jet Ventilation Techniques

Study Overview
=================
Brief Summary
-----------------
Endoscopic microsurgical procedures of the larynx (direct examination-bx, microlaryngeal resection) require the anesthesiologist and surgeon to work in the same area throughout the procedure, and while ventilation is provided during the procedure, small diameter endotracheal tubes are preferred to see the surgical area as easily as possible. However, it is sometimes observed that even conventional endotracheal tubes of this diameter make surgery difficult by obstructing the view. On the other hand, apneic laryngoscopy techniques used in upper airway surgeries, such as microlaryngoscopy and laryngotracheal surgery, where the airway is shared by the anesthesiologist and surgeon, have been replaced by safer and controlled high-frequency jet ventilation applications due to the risk of hypoxemia and hypercapnia. In recent years, oxygenation has come to the fore with Transnasal High Flow Insufflation (OptiflowTM - Fischer &amp; Paykel Healthcare, Auckland, New Zealand), an apneic oxygenation method. This randomized study aimed to compare the effects of high-flow nasal oxygen and jet ventilation on oxygenation in patients receiving general anaesthesia for endolaryngeal surgery.

Detailed Description
-----------------
Endoscopic microsurgical procedures of the larynx (direct examination- bx, microlaryngeal resection) require the anesthesiologist and surgeon to work in the same area throughout the procedure, and while ventilation is provided during the procedure, small diameter endotracheal tubes are preferred to see the surgical area as easily as possible. However, it is sometimes observed that even conventional endotracheal tubes of this diameter make surgery difficult by obstructing the view. On the other hand, apneic laryngoscopy techniques used in upper airway surgeries, such as microlaryngoscopy and laryngotracheal surgery, where the airway is shared by the anesthesiologist and surgeon, have been replaced by safer and controlled high-frequency jet ventilation applications due to the risk of hypoxemia and hypercapnia. In recent years, oxygenation has come to the fore with Transnasal High Flow Insufflation (OptiflowTM - Fischer &amp; Paykel Healthcare, Auckland, New Zealand), an apneic oxygenation method. High-flow nasal cannula has been used, especially in critically ill patients. It is a system that delivers oxygen with high flow (up to 70 L/min) consisting of an air-oxygen mixer, an active heated humidifier, a single heated circuit and a nasal cannula. Heated and humidified high-flow oxygen prolongs the time of preoxygenation and apneic oxygenation. In both jet ventilation and optiflow ventilation, gas exchange parameters of the patient can be measured by pulse oximetry, capnography, arterial blood gas or transcutaneous blood gas measurements. Determining the CO2 status (end-tidal CO2-ETCO2) in both techniques is quite difficult due to large leaks in the exhaled gas. Determining the patient's CO2 level is valuable as it shows the gas exchange. Ventilation settings are made according to this parameter. Arterial blood gas measurements can be performed for this purpose, but their invasiveness is limiting. An alternative method for assessing CO2 status is the nasal ETCO2 measurement. Evaluation of ventilation and oxygenation with nasally applied ETCO2 monitoring is a simple application that will bring patient safety to higher levels. In evaluating the adequacy of ventilation, basal ETCO2 values should be taken during the patient&#39;s spontaneous breathing. This value should be compared with the values obtained during jet ventilation and transnasal high-flow oxygenation. This randomized clinical study aims to compare the effects of high-flow nasal oxygen and jet ventilation on oxygenation in patients receiving general anaesthesia for endolaryngeal surgery. Within the scope of this purpose, we determined to evaluate PaCO2, PaCO2 and Ph changes (before preoxygenation, before induction, and every 5 minutes after induction) with arterial blood gas analysis as the primary purpose.As a secondary aim, we will review that arterial blood gas analysis is used to determine PaO2 and pH changes (pre-induction, preoxygenation, every 5 minutes after induction), duration of apnea, arterial and nasal ETCO2 values, anesthesia duration, operation time, surgical satisfaction, respiratory and hemodynamic complications. After the approval of the Academic Ethics Committee, patients aged>18 years and ASA I-II,who are scheduled for endolaryngeal surgery under general anesthesia, will be included in the randomized study. The patients will be randomized by the closed envelope method and divided into the jet ventilation group and the optiflow group. After premedication with midazolam 2mg IV, all patients will be taken to the operating room and monitored with standard monitoring methods (SPO2, KTA, SAB, DAB, OAB). In addition to standard monitoring, invasive arterial and nasal ETCO2 monitoring will be applied to all patients after general anesthesia induction. The patients in the first group will be ventilated with jet ventilation after induction, and the patients in the second group will be oxygenated with optiflow (OptiflowTM - Fischer &amp; Paykel Healthcare, Auckland, New Zealand). Anesthesia will be maintained with remifentanil+propofol infusion in both groups. Anesthesia depth BIS (BIS PECTORAL INDEX) monitoring will be provided. At the end of the operation, all patients will be placed on conventional ventilation by placing a supraglottic airway, and decurarization will be provided with sugammadex. Arterial blood gas analysis will be recorded in all patients by measuring PaCO2, PaCO2 and pH changes (before preoxygenation, before induction, and every 5 minutes after induction). In addition, as a secondary output of the study, arterial blood gas analysis and PaO2 and pH changes (pre-induction, pre-oxygenation, every 5 minutes after induction), time to stay in apnea, arterial PaCO2 (spontaneous breathing, 5th min, 15th min, 20th min, 30 min, at the end of the operation, at mechanical ventilation) and nasal ETCO2 (pre-induction, during the first spontaneous breathing during awakening, during mechanical ventilation), anesthesia duration, operation time, surgical satisfaction, respiratory and hemodynamic complications will be recorded. This randomized study aimed to compare the effects of high-flow nasal oxygen and jet ventilation on oxygenation in patients who will receive general anesthesia for endolaryngeal surgery.

Official Title
-----------------
Comparison of the Effects of High Flow Nasal Cannula Oxygen and Jet Ventilation Techniques on Oxygenation in Endolaryngeal Surgery

Conditions
-----------------
pH, Oxygen, End-tidal Carbon Dioxide

Intervention / Treatment
-----------------
* Procedure: oxygenization techniques


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ASA I-II status Patients who will receive general anesthesia for endolaryngeal surgery >18 years old Volunteer to participate in the study Exclusion Criteria: <18 years old MI (EF<%50) Arrhythmia Peripheral vascular disease Cerebrovascular disease Electrolyte disorder Severe COPD Chronic hypoxia (baseline SPO2<95%) BMI>35 kg/m2 Refusal to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: jet ventilation group<br>Jet ventilation | |
| Experimental: Optiflow group<br>High flow nasal oxygen | Procedure: oxygenization techniques<br>* to compare the effects of high-flow nasal oxygen and jet ventilation on oxygenation in patients who will receive general anesthesia for endolaryngeal surgery.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaCO2 change | PaCO2 change (before preoxygenation, before induction, every 5 minutes after induction) was recorded by arterial blood gas analysis. | Intraoperative | 
| Ph change | Ph changes (before preoxygenation, before induction, every 5 minutes after induction) were recorded by arterial blood gas analysis | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial ETCO2 values | Arteryal ETCO2 values were evaluated with arterial blood gas and recorded. | Intraoperative | 
| Nasal ETCO2 values | Nasal ETCO2 values were evaluated with arterial blood gas and recorded. | Intraoperative | 
| Anesthesia duration | Anesthesia time was recorded | Intraoperative | 
| Surgery time | Surgery time was recorded | Intraoperative | 
| Surgical satisfaction questionnaire | Surgical satisfaction was evaluated and recorded | Intraoperative | 
| Respiratory complications | Possible respiratory complications were recorded | Intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
high-frequency jet ventilation, high flow nasal oxygenation