OxygenNCT05746949
Comparison of the Effects of High-flow Nasal Cannula Oxygen and Jet Ventilation Techniques
A study testing oxygenization techniques in people with Oxygen and pH, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oxygen, pH, End-tidal Carbon Dioxide
- What is being tested?
- oxygenization techniques
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Feb 2023to 4 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with ASA I-II status
- Patients who will receive general anesthesia for endolaryngeal surgery
- >18 years old
- Volunteer to participate in the study
Who cannot join
- <18 years old
- MI (EF<%50)
- Arrhythmia
- Peripheral vascular disease
- Cerebrovascular disease
- Electrolyte disorder
Show all 10Show fewer
- Severe COPD
- Chronic hypoxia
- BMI>35 kg/m2
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Department of Anesthesiology
Istanbul, Fatih, 34093
About this study
Official title: Comparison of the Effects of High Flow Nasal Cannula Oxygen and Jet Ventilation Techniques on Oxygenation in Endolaryngeal Surgery: A Randomized Controlled Trial
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.
Read more
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.
Read the 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 patients 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.
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, PaO2 and pH changes ( before induction, every 10 minutes after induction and at the end of the operation). During the operation, arterial blood gas was used as the primary output to record PaCO2 levels at five different times for all patients: before induction (T0) as baseline values, 10 minutes after induction (T1), 20 minutes after induction (T2), 30 minutes after induction (T3), and at the end of the operation (T4). As secondary outputs, arterial blood gas analysis recorded the patients' PaO2, pH, HCO3, BE, Hb, and lactate values, as well as vital parameters such as MAP, HR, and SpO2, at five separate times: before induction (T0) as baseline values, 10 minutes after induction (T1), 20 minutes after induction (T2), 30 minutes after induction (T3), and at the end of the operation (T4). Additionally, the highest PaO2 and PaCO2 values and the lowest SpO2 values during the perioperative period were recorded. Furthermore, the duration of the operation and changes in respiratory and hemodynamic parameters during the operation were evaluated.
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.
- Conditions
- Oxygen, pH, End-tidal Carbon Dioxide
- Being tested
- oxygenization techniques
- Keywords
- high-frequency jet ventilation, high flow nasal oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxygenization techniquesProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| jet ventilation group | No intervention | Jet ventilation |
| Optiflow group | Experimental | High flow nasal oxygen Receives: Procedure: oxygenization techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaCO2 change
PaCO2 change (before preoxygenation, before induction, every 5 minutes after induction) was recorded by arterial blood gas analysis.
Measured: Intraoperative
Ph change
Ph changes (before preoxygenation, before induction, every 5 minutes after induction) were recorded by arterial blood gas analysis
Measured: Intraoperative
Secondary outcomes (6)
Arterial ETCO2 values
Arteryal ETCO2 values were evaluated with arterial blood gas and recorded.
Measured: Intraoperative
Nasal ETCO2 values
Nasal ETCO2 values were evaluated with arterial blood gas and recorded.
Measured: Intraoperative
Anesthesia duration
Anesthesia time was recorded
Measured: Intraoperative
Surgery time
Surgery time was recorded
Measured: Intraoperative
Surgical satisfaction questionnaire
Surgical satisfaction was evaluated and recorded
Measured: Intraoperative
Respiratory complications
Possible respiratory complications were recorded
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start18 Feb 2023
- Primary completion3 Jun 2024
- Study completion4 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OxygenStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet Altun, Istanbul University
- Investigators
- Seda Özdağlı, Resident, Principal investigator, Istanbul UniversityDemet Altun, Assoc. Prof., Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746949
- Sponsor's protocol ID
- 2018/43
- Status last verified
- Jun 2024
- First submitted
- 17 Feb 2023
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Patel A, Nouraei SA. Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): a physiological method of increasing apnoea time in patients with difficult airways. Anaesthesia. 2015 Mar;70(3):323-9. doi: 10.1111/anae.12923. Epub 2014 Nov 10.
PubMed 25388828Lyons C, Callaghan M. Apnoeic oxygenation with high-flow nasal oxygen for laryngeal surgery: a case series. Anaesthesia. 2017 Nov;72(11):1379-1387. doi: 10.1111/anae.14036.
PubMed 29047136Ozdagli S, Canbaz M, Camci E, Kirsan N, Akdogan B, Altun D, Celik M, Altun D. Comparison of the Effects of High-Flow Nasal Cannula Oxygen and Jet Ventilation Techniques. Laryngoscope. 2026 Oct 6. doi: 10.1002/lary.70970. Online ahead of print.
PubMed 42838698
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of High Flow Nasal Cannula Oxygen and Jet Ventilation Techniques on Oxygenation in Endolaryngeal Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05746949
- Acronym / sponsor ID
- 2018/43
- Conditions
- Oxygen, pH, End-tidal Carbon Dioxide
- Keywords
- high-frequency jet ventilation, high flow nasal oxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 18 Feb 2023 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 4 Jun 2024 (actual)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 patients 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.
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, PaO2 and pH changes ( before induction, every 10 minutes after induction and at the end of the operation). During the operation, arterial blood gas was used as the primary output to record PaCO2 levels at five different times for all patients: before induction (T0) as baseline values, 10 minutes after induction (T1), 20 minutes after induction (T2), 30 minutes after induction (T3), and at the end of the operation (T4). As secondary outputs, arterial blood gas analysis recorded the patients' PaO2, pH, HCO3, BE, Hb, and lactate values, as well as vital parameters such as MAP, HR, and SpO2, at five separate times: before induction (T0) as baseline values, 10 minutes after induction (T1), 20 minutes after induction (T2), 30 minutes after induction (T3), and at the end of the operation (T4). Additionally, the highest PaO2 and PaCO2 values and the lowest SpO2 values during the perioperative period were recorded. Furthermore, the duration of the operation and changes in respiratory and hemodynamic parameters during the operation were evaluated.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| jet ventilation group | No intervention | –Jet ventilation |
| Optiflow group | Experimental | Procedure: oxygenization techniquesHigh flow nasal oxygen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with ASA I-II status
- Patients who will receive general anesthesia for endolaryngeal surgery
- >18 years old
- Volunteer to participate in the study
Key exclusion criteria (10 listed)
- <18 years old
- MI (EF<%50)
- Arrhythmia
- Peripheral vascular disease
- Cerebrovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxygenization techniquesto compare the effects of high-flow nasal oxygen and jet ventilation on oxygenation in patients who will receive general anesthesia for endolaryngeal surgery. | Procedure or surgery | Optiflow group |
Primary outcome
PaCO2 change
Time frame: Intraoperative
PaCO2 change (before preoxygenation, before induction, every 5 minutes after induction) was recorded by arterial blood gas analysis.
Ph change
Time frame: Intraoperative
Ph changes (before preoxygenation, before induction, every 5 minutes after induction) were recorded by arterial blood gas analysis
6 secondary outcomes
Arterial ETCO2 values
Time frame: Intraoperative
Nasal ETCO2 values
Time frame: Intraoperative
Anesthesia duration
Time frame: Intraoperative
Surgery time
Time frame: Intraoperative
Surgical satisfaction questionnaire
Time frame: Intraoperative
Respiratory complications
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Background: PubMed 25388828Patel A, Nouraei SA. Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): a physiological method of increasing apnoea time in patients with difficult airways. Anaesthesia. 2015 Mar;70(3):323-9. doi: 10.1111/anae.12923. Epub 2014 Nov 10.
- Background: PubMed 29047136Lyons C, Callaghan M. Apnoeic oxygenation with high-flow nasal oxygen for laryngeal surgery: a case series. Anaesthesia. 2017 Nov;72(11):1379-1387. doi: 10.1111/anae.14036.
- Derived from this study: PubMed 42838698Ozdagli S, Canbaz M, Camci E, Kirsan N, Akdogan B, Altun D, Celik M, Altun D. Comparison of the Effects of High-Flow Nasal Cannula Oxygen and Jet Ventilation Techniques. Laryngoscope. 2026 Oct 6. doi: 10.1002/lary.70970. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seda Özdağlı, Resident principal investigator
Istanbul University
Demet Altun, Assoc. Prof. principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oxygenization techniques in people with Oxygen and pH, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PaCO2 change (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05746949, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.