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NCT Number: NCT07662304

Effect of Continuous Supraglottic Oxygen Insufflation Via Video Laryngoscope Blade on Apneic Oxygenation During Tracheal Intubation Under General Anesthesia

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged between 18 and 75 years, with ASA physical status I to III, and scheduled for surgery with general anaesthesia and orotracheal intubation

Exclusion criteria

  • 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

Treatment and study plan

control group (Group C)

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. PaO2 at before preoxygenation

    Time frame: Baseline (before preoxygenation)

  2. PaO2 at 1 minutes when intubation criteria are met

    Time frame: 1 minute after intubation

  3. PaO2 at 2 minute when intubation criteria are met

    Time frame: 2 minute after intubation

  4. PaO2 at 5 minutes when intubation criteria are met

    Time frame: 5 minute after intubation

  5. PaCO2 changes during apnoea

    Time frame: up to 24 hours (during apnoea)

  6. all complicatios at 24 hours postoperatively.

    Time frame: at 24 hours postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Daqing Pei

CONTACT

[email protected]

+8615068353937

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Jiaxing University

Other

Collaborators

  • The Second Affiliated Hospital of Jiaxing University

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2029
First posted
Jun 23, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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