An interventional study of control group (Group C) and The continuous laryngeal oxygen supply group (Group B) in Apneic Oxygenation, sponsored by Affiliated Hospital of Jiaxing University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by Affiliated Hospital of Jiaxing University · Not applicable, Interventional, and Prevention
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.
Affiliated Hospital of Jiaxing University is the lead sponsor of 17 studies on the registry; 10 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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) 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)
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) 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.
arterial partial pressure of oxygen (PaO2) at 3 min
arterial partial pressure of oxygen (PaO2) at 3 min when intubation criteria are met
Time frame: 3 minutes after intubation
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
No study locations are listed for this record.
Plan to share: Yes
Supporting information: Study protocol
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Jun 2026, 0 months later.
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Affiliated Hospital of Jiaxing University