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

NCT07662304 | Not Yet Recruiting DMC

• 1 other identifier: 2026-073-02
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Keywords

video laryngoscope

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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)

Study Arms (2)

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.

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

Device: The continuous laryngeal oxygen supply group (Group B)

Interventions

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.

control group (Group C)

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.

The continuous laryngeal oxygen supply group (Group B)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Affiliated Hospital of Jiaxing University: lead
• The Second Affiliated Hospital of Jiaxing University: collaborator

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Daqing Pei

CONTACT

+8615068353937; ph287594683@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: June 23, 2026
• Study Start: June 22, 2026
• Primary Completion: June 22, 2026
• Study Completion (Estimated): June 22, 2029
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL