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

February 27, 2023 updated by: Demet Altun, Istanbul University

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

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as microlaryngoscopy and laryngotracheal surgery, where the airway is shared by the anesthesiologist and surgeon, have been replaced by safer and controlled high-frequency jet ventilation applications due to the risk of hypoxemia and hypercapnia.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 & 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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as microlaryngoscopy and laryngotracheal surgery, where the airway is shared by the anesthesiologist and surgeon, have been replaced by safer and controlled high-frequency jet ventilation applications due to the risk of hypoxemia and hypercapnia.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 & 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'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 & 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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey, 34093
        • Recruiting
        • Istanbul University, Department of Anesthesiology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PaCO2 change
Time Frame: Intraoperative
PaCO2 change (before preoxygenation, before induction, every 5 minutes after induction) was recorded by arterial blood gas analysis.
Intraoperative
Ph change
Time Frame: Intraoperative
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
Time Frame: Intraoperative
Arteryal ETCO2 values were evaluated with arterial blood gas and recorded.
Intraoperative
Nasal ETCO2 values
Time Frame: Intraoperative
Nasal ETCO2 values were evaluated with arterial blood gas and recorded.
Intraoperative
Anesthesia duration
Time Frame: Intraoperative
Anesthesia time was recorded
Intraoperative
Surgery time
Time Frame: Intraoperative
Surgery time was recorded
Intraoperative
Surgical satisfaction questionnaire
Time Frame: Intraoperative
Surgical satisfaction was evaluated and recorded
Intraoperative
Respiratory complications
Time Frame: Intraoperative
Possible respiratory complications were recorded
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Principal Investigator: Demet Altun, Assoc. Prof., Istanbul University
  • Principal Investigator: Seda Özdağlı, Resident, Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2023

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 15, 2023

Study Registration Dates

First Submitted

February 17, 2023

First Submitted That Met QC Criteria

February 27, 2023

First Posted (Estimate)

February 28, 2023

Study Record Updates

Last Update Posted (Estimate)

February 28, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018/43

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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