Menu
Not yet recruiting NCT07662304

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

No phase Interventional Apneic Oxygenation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: control group (Group C), The continuous laryngeal oxygen supply group (Group B).
Who it may be relevant to
Registry conditions: Apneic Oxygenation. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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 in
  • 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 b

Primary outcome measures

  • arterial partial pressure of oxygen (PaO2) at 3 min [Time frame: 3 minutes after intubation]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07662304 · 2026-073-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗