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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07662304
Enrollment
150
Registered
2026-06-23
Start date
2026-06-22
Completion date
2029-06-22
Last updated
2026-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apneic Oxygenation

Keywords

video laryngoscope

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.

Interventions

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.

DEVICEThe 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.

Sponsors

Affiliated Hospital of Jiaxing University
Lead SponsorOTHER
The Second Affiliated Hospital of Jiaxing University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
arterial partial pressure of oxygen (PaO2) at 3 min3 minutes after intubationarterial partial pressure of oxygen (PaO2) at 3 min when intubation criteria are met

Secondary

MeasureTime frame
PaO2 at before preoxygenationBaseline (before preoxygenation)
PaO2 at 1 minutes when intubation criteria are met1 minute after intubation
PaO2 at 2 minute when intubation criteria are met2 minute after intubation
PaO2 at 5 minutes when intubation criteria are met5 minute after intubation
PaCO2 changes during apnoeaup to 24 hours (during apnoea)
all complicatios at 24 hours postoperatively.at 24 hours postoperatively

Contacts

CONTACTDaqing Pei
ph287594683@163.com+8615068353937

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 24, 2026