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.

Study Overview

• Status: Not yet recruiting
• Conditions: Apneic Oxygenation
• Intervention / Treatment: Procedure: control group (Group C); Device: The continuous laryngeal oxygen supply group (Group B)

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daqing Pei; Phone Number: +8615068353937; Email: ph287594683@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.
Experimental: 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	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. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
arterial partial pressure of oxygen (PaO2) at 3 min	arterial partial pressure of oxygen (PaO2) at 3 min when intubation criteria are met	3 minutes after intubation

Secondary Outcome Measures

Outcome Measure	Time Frame
PaO2 at before preoxygenation	Baseline (before preoxygenation)
PaO2 at 1 minutes when intubation criteria are met	1 minute after intubation
PaO2 at 2 minute when intubation criteria are met	2 minute after intubation
PaO2 at 5 minutes when intubation criteria are met	5 minute after intubation
PaCO2 changes during apnoea	up to 24 hours (during apnoea)
all complicatios at 24 hours postoperatively.	at 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Jiaxing University
• Collaborators: The Second Affiliated Hospital of Jiaxing University

Study record dates

Study Major Dates

• Study Start (Estimated): June 22, 2026
• Primary Completion (Estimated): June 22, 2026
• Study Completion (Estimated): June 22, 2029

Study Registration Dates

• First Submitted: June 14, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: video laryngoscope
• Additional Relevant MeSH Terms: Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: 2026-073-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No