Feasibility of Preoxygenation by Supraglottic Jet Ventilation Before Endotracheal Intubation

Study Overview
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Brief Summary
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The study assumed that supraglottic jet ventilation is an alternative solution as a safe way to do the preoxygenation before endotracheal intubation by contrasting it with mask pressurized ventilation. The investigators also expected that supraglottic jet ventilation won't increase the occurrence of esophageal reflux.

Detailed Description
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The study assumed that supraglottic jet ventilation is an alternative solution as a safe way to do the preoxygenation before endotracheal intubation by contrasting it with mask pressurized ventilation. The investigators also expected that supraglottic jet ventilation won't increase the occurrence of esophageal reflux. The investigators randomly divided the patients into 2 groups:Group C and Group S.Patients in Group C will be preoxygenation with mask pressurized ventilation while patients in Group S with supraglottic jet ventilation by Wei NASAL JET（WNJ）.The tracheal intubation will be done after the 3 minutes preoxygenation. The investigators will measure the PaCO2 before and after preoxygenation, and the investigators will take the stomach-ultrasonography to find if there are too much gas in the gastro. If pulse oximetry is lower than 95% during the preoxygenation, the investigators will adjust the position of the Wei NASAL JET（WNJ) or use the change the way that the investigators hold the mask or change the pressure of ventilation on the basis of the group.

Official Title
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Feasibility of Preoxygenation by Supraglottic Jet Ventilation Substituted for Mask Pressurized Ventilation Before Endotracheal Intubation:A Randomized Controlled Trail

Conditions
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Preoxygenation

Intervention / Treatment
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* Device: supraglottic jet ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: scheduled for any surgery under general anesthesia adults age range from 18-64 years old American Society of Anesthesiologists Physical Status Classification (ASA class) I-II voluntary participation in this clinical trail, signed informed consents Exclusion Criteria: patients with epistaxis, rhinostenosis, the episodes of rhinitis, severe gastroesophageal reflux disease, severe respiratory disease, severe cardiovascular and cerebrovascular disease long-term use if anticoagulant drugs can't cooperate with intervention pulse oximetry <95% with normal respiration

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: supraglottic jet ventilation group<br>Check blood gas before induction without preoxygen. Take stomach-ultrasound. Induction with Midazolam 0.02 mg/kg, sufentanil 0.3   0.5 ug/kg, propofol 2-2.5 mg/kg, rocuronium 0.6 mg/kg.After patients fall asleep and can't be woke up ,the investigators will put the Wei NASAL JET（WNJ）into one's nose to give the supraglottic jet ventilation with the driving pressure 0.01-0.03 megapascal (MPa), respiratory rate 15 beats per minute（BPM）, inspiratory/expiratory rate 1-1. 5.Check blood gas,stomach-ultrasound after 3 min, then do the tracheal intubation guided by visual laryngoscope.Stop jet ventilation during intubation. | Device: supraglottic jet ventilation<br>* patients who were randomized into supraglottic jet ventilation group would be placed Wei Nasal Jet Tube after conducted. Then they will get the supraglottic jet ventilation to make sure their pulse oximetry is over 95%. After 3 minutes, endotracheal intubation was performed via mouth approach.<br>|
| No Intervention: mask pressurized ventilation group<br>Check blood gas before induction without preoxygen. Take stomach-ultrasound. Induction with Midazolam 0.02 mg/kg, sufentanil 0.3   0.5 ug/kg, propofol 2-2.5 mg/kg, rocuronium 0.6 mg/kg.After patients fall asleep and can't be woke up ,the investigators will give them 1 min mask pressure respiration, by pressure control V - E technique after muscle relaxant. Check blood gas,stomach-ultrasound after 2 min, then do the tracheal intubation guided by visual laryngoscope. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| alveolar oxygen tension（PaO2） | The results comes from blood gas analysis | 3 minutes after preoxygenation | 
| alveolar oxygen tension（PaO2） | The results comes from blood gas analysis | baseline (before preoxygenation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaCO2 | The results comes from blood gas analysis | 3 minutes after preoxygenation | 
| PaCO2 | The results comes from blood gas analysis | baseline (before preoxygenation) | 
| gastric antrum cross section | The results comes from the ultrasound of gastric | 3 minutes after preoxygenation | 
| gastric antrum cross section | The results comes from the ultrasound of gastric | baseline (before preoxygenation) | 
| complications | such as nasal bleeding, dry throat itching, sore throat, nausea and vomiting, pressure and other adverse reactions | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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jet ventilation, supraglottic