Apneic OxygenationNCT07662304
Effect of Continuous Supraglottic Oxygen Insufflation Via Video Laryngoscope Blade on Apneic Oxygenation During Tracheal Intubation Under General Anesthesia
A study testing The continuous laryngeal oxygen supply group (Group B) in people with Apneic Oxygenation, run by Affiliated Hospital of Jiaxing University.
Trial summary
This study is a prospective, randomized controlled clinical trial aimed at investigating the efficacy and safety of a novel oxygenating video laryngoscope blade during apneic oxygenation for intubation under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Apneic Oxygenation
- What is being tested?
- The continuous laryngeal oxygen supply group (Group B)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 22 Jun 2026to 22 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 75 years, with ASA physical status I to III, and scheduled for surgery with general anaesthesia and orotracheal intubation
Who cannot join
- cardiac disease (ischaemic heart disease, heart failure [NYHA ≥2 ],current arrhythmias, pulmonary hypertension)
- severe asthma, moderate to severe chronic obstructive pulmonary disease
- pregnancy
- baseline oxygen saturation <95%
- not capable of understanding study information and signing a written consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study is a prospective, randomized controlled clinical trial aimed at investigating the efficacy and safety of a novel oxygenating video laryngoscope blade during apneic oxygenation for intubation under general anesthesia. Hypoxemia is prone to occur during anesthesia induction, which can lead to severe complications. Apneic oxygenation is an important method to prolong the safe apnea time, but existing oxygen delivery modalities have limitations in applicability. Although the laryngeal oxygen delivery approach combined with video laryngoscopy has theoretical advantages, clinical evidence is insufficient. Therefore, this study was conducted.
- Conditions
- Apneic Oxygenation
- Being tested
- control group (Group C), The continuous laryngeal oxygen supply group (Group B)
- Keywords
- video laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control group (Group C)Procedure or surgery
Before surgery, all participants received a radial arterial line. At arrival to the operating theatre, ECG, invasive arterial blood pressure, pulse oximetry, and train-of-four monitoring were applied. An i.v. line was secured, and a standard infusion of electrolyte solution was started. Participants were then placed supine, in a 10 degrees reverse Trendelenburg position. Preoxygenation was then perform using atight fitting face mask and having each subject breathe 100% O2 at 15 L/min.Tracheal intubation was thereafter performed using a video laryngoscope when the anaesthetist assessed the conditions as appropriate in the control group (Group C).The correct placement of the tracheal tube was confirmed visually by the anaesthetist in charge and a member of the study team. The tracheal tube was secured, and the participant was left apnoeic with the tracheal tube open to the atmosphere until the peripheral oxygen saturation declined to 93% or apnoea is sustained for 5 minutes.
The continuous laryngeal oxygen supply group (Group B)Device
The continuous laryngeal oxygen supply group (Group B) used the same preoxygenation and anesthesia induction methods as the control group. When intubation conditions were assessed to be met, laryngoscopy was performed to evaluate the airway. If the laryngoscopic view was Cormack and Lehane grade 3 or grade 4, the subject was excluded from the study and tracheal intubation was performed. Otherwise, continuous laryngeal oxygen supply was initiated through a modified disposable video laryngoscope blade, which has an internal lumen. The distal end of the blade is connected to an oxygen delivery tube, and the other end of the oxygen delivery tube is connected to a flowmeter, with an oxygen flow rate of 10 L/min to maintain a continuous oxygen supply to the larynx. Upon reaching an SpO2 of 93% or apnoea is sustained for 5 minutes, tracheal intubation and mechanical ventilation was commenced, and the protocol was terminated.
| Study group | Role | What they receive |
|---|---|---|
| control group (Group C) | Active comparator | Before surgery, all participants received a radial arterial line. Participants were then placed supine, in a 10 degrees reverse Trendelenburg position. Preoxygenation was then performed using atight fitting face mask and having Tracheal intubation was thereafter performed using a video laryngoscopewhen the anaesthetist assessed the conditions as appropriate in the control group (Group C).The correct placement of the tracheal tube was confirmed visually by the anaesthetist in charge and a member of the study team. The tracheal tube was secured, and the participant was left apnoeic with the tracheal tube open to the atmosphere until the peripheral oxygen saturation declined to 93% or apnoea is sustained for 5 minutes. Receives: Procedure: control group (Group C) |
| The continuous laryngeal oxygen supply group (Group B) | Experimental | The continuous laryngeal oxygen supply group (Group B) used the same preoxygenation and anesthesia induction methods as the control group. When intubation conditions were assessed to be met, laryngoscopy was performed to evaluate the airway. If the laryngoscopic view was Cormack and Lehane grade 3 or grade 4, the subject was excluded from the study and tracheal intubation was performed. Otherwise, continuous laryngeal oxygen supply was initiated through a modified disposable video laryngoscope blade, which has an internal lumen. The distal end of the blade is connected to an oxygen delivery tube, and the other end of the oxygen delivery tube is connected to a flowmeter, with an oxygen flow rate of 10 L/min to maintain a continuous oxygen supply to the larynx. During apnoea, anaesthesia was maintained with intermittent boluses of propofol and, if necessary, either infusion of remifentanil. Upon reaching an SpO2 of 93% or apnoea is sustained for 5 minutes, tracheal intubation and mechan Receives: Device: The continuous laryngeal oxygen supply group (Group B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial partial pressure of oxygen (PaO2) at 3 min
arterial partial pressure of oxygen (PaO2) at 3 min when intubation criteria are met
Measured: 3 minutes after intubation
Secondary outcomes (6)
PaO2 at before preoxygenation
Measured: Baseline (before preoxygenation)
PaO2 at 1 minutes when intubation criteria are met
Measured: 1 minute after intubation
PaO2 at 2 minute when intubation criteria are met
Measured: 2 minute after intubation
PaO2 at 5 minutes when intubation criteria are met
Measured: 5 minute after intubation
PaCO2 changes during apnoea
Measured: up to 24 hours (during apnoea)
all complicatios at 24 hours postoperatively.
Measured: at 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start22 Jun 2026 (estimated)
- Primary completion22 Jun 2026 (estimated)
- Study completion22 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apneic OxygenationStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Jiaxing University
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Jiaxing University
- Responsible party
- Principal investigator, Qing-he Zhou, The Second Affiliated Hospital of Jiaxing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662304
- Sponsor's protocol ID
- 2026-073-02
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Supraglottic Oxygen Insufflation Via Video Laryngoscope Blade on Apneic Oxygenation During Tracheal Intubation Under General Anesthesia
- ClinicalTrials.gov ID
- NCT07662304
- Acronym / sponsor ID
- 2026-073-02
- Conditions
- Apneic Oxygenation
- Keywords
- video laryngoscope
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Jiaxing UniversityUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Jiaxing University
- Study start
- 22 Jun 2026 (estimated)
- Primary completion
- 22 Jun 2026 (estimated)
- Study completion
- 22 Jun 2029 (estimated)
- First posted
- 23 Jun 2026 (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.
This study is a prospective, randomized controlled clinical trial aimed at investigating the efficacy and safety of a novel oxygenating video laryngoscope blade during apneic oxygenation for intubation under general anesthesia. Hypoxemia is prone to occur during anesthesia induction, which can lead to severe complications. Apneic oxygenation is an important method to prolong the safe apnea time, but existing oxygen delivery modalities have limitations in applicability. Although the laryngeal oxygen delivery approach combined with video laryngoscopy has theoretical advantages, clinical evidence is insufficient. Therefore, this study was conducted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group (Group C) | Active comparator | Procedure: control group (Group C)Before surgery, all participants received a radial arterial line. Participants were then placed supine, in a 10 degrees reverse Trendelenburg position. Preoxygenation was then performed using atight fitting face mask and having Tracheal intubation was thereafter performed using a video laryngoscopewhen the anaesthetist assessed the conditions as appropriate in the control group (Group C).The correct placement of the tracheal tube was confirmed visually by the anaesthetist in charge and a member of the study team. The tracheal tube was secured, and the participant was left apnoeic with the tracheal tube open to the atmosphere until the peripheral oxygen saturation declined to 93% or apnoea is sustained for 5 minutes. |
| The continuous laryngeal oxygen supply group (Group B) | Experimental | Device: The continuous laryngeal oxygen supply group (Group B)The continuous laryngeal oxygen supply group (Group B) used the same preoxygenation and anesthesia induction methods as the control group. When intubation conditions were assessed to be met, laryngoscopy was performed to evaluate the airway. If the laryngoscopic view was Cormack and Lehane grade 3 or grade 4, the subject was excluded from the study and tracheal intubation was performed. Otherwise, continuous laryngeal oxygen supply was initiated through a modified disposable video laryngoscope blade, which has an internal lumen. The distal end of the blade is connected to an oxygen delivery tube, and the other end of the oxygen delivery tube is connected to a flowmeter, with an oxygen flow rate of 10 L/min to maintain a continuous oxygen supply to the larynx. During apnoea, anaesthesia was maintained with intermittent boluses of propofol and, if necessary, either infusion of remifentanil. Upon reaching an SpO2 of 93% or apnoea is sustained for 5 minutes, tracheal intubation and mechan |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged between 18 and 75 years, with ASA physical status I to III, and scheduled for surgery with general anaesthesia and orotracheal intubation
Key exclusion criteria (5 listed)
- cardiac disease (ischaemic heart disease, heart failure [NYHA ≥2 ],current arrhythmias, pulmonary hypertension)
- severe asthma, moderate to severe chronic obstructive pulmonary disease
- pregnancy
- baseline oxygen saturation <95%
- not capable of understanding study information and signing a written consent
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 |
|---|---|---|
| control group (Group C)Before surgery, all participants received a radial arterial line. At arrival to the operating theatre, ECG, invasive arterial blood pressure, pulse oximetry, and train-of-four monitoring were applied. An i.v. line was secured, and a standard infusion of electrolyte solution was started. Participants were then placed supine, in a 10 degrees reverse Trendelenburg position. Preoxygenation was then perform using atight fitting face mask and having each subject breathe 100% O2 at 15 L/min.Tracheal intubation was thereafter performed using a video laryngoscope when the anaesthetist assessed the conditions as appropriate in the control group (Group C).The correct placement of the tracheal tube was confirmed visually by the anaesthetist in charge and a member of the study team. The tracheal tube was secured, and the participant was left apnoeic with the tracheal tube open to the atmosphere until the peripheral oxygen saturation declined to 93% or apnoea is sustained for 5 minutes. | Procedure or surgery | control group (Group C) |
| The continuous laryngeal oxygen supply group (Group B)The continuous laryngeal oxygen supply group (Group B) used the same preoxygenation and anesthesia induction methods as the control group. When intubation conditions were assessed to be met, laryngoscopy was performed to evaluate the airway. If the laryngoscopic view was Cormack and Lehane grade 3 or grade 4, the subject was excluded from the study and tracheal intubation was performed. Otherwise, continuous laryngeal oxygen supply was initiated through a modified disposable video laryngoscope blade, which has an internal lumen. The distal end of the blade is connected to an oxygen delivery tube, and the other end of the oxygen delivery tube is connected to a flowmeter, with an oxygen flow rate of 10 L/min to maintain a continuous oxygen supply to the larynx. Upon reaching an SpO2 of 93% or apnoea is sustained for 5 minutes, tracheal intubation and mechanical ventilation was commenced, and the protocol was terminated. | Device | The continuous laryngeal oxygen supply group (Group B) |
Primary outcome
arterial partial pressure of oxygen (PaO2) at 3 min
Time frame: 3 minutes after intubation
arterial partial pressure of oxygen (PaO2) at 3 min when intubation criteria are met
6 secondary outcomes
PaO2 at before preoxygenation
Time frame: Baseline (before preoxygenation)
PaO2 at 1 minutes when intubation criteria are met
Time frame: 1 minute after intubation
PaO2 at 2 minute when intubation criteria are met
Time frame: 2 minute after intubation
PaO2 at 5 minutes when intubation criteria are met
Time frame: 5 minute after intubation
PaCO2 changes during apnoea
Time frame: up to 24 hours (during apnoea)
all complicatios at 24 hours postoperatively.
Time frame: at 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing The continuous laryngeal oxygen supply group (Group B) in people with Apneic Oxygenation, run by Affiliated Hospital of Jiaxing University.
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 1 inclusion and 5 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: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daqing Pei (+8615068353937, ph287594683@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arterial partial pressure of oxygen (PaO2) at 3 min (time frame: 3 minutes after intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2026.