Nasal Ventilation vs Face Mask

Study Overview
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Brief Summary
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Nasotracheal intubation(NTI) is commonly used in operations of the mouth, pharynx, larynx and also the neck. While these patients showed higher rates of difficult laryngoscopy. Therefore, duration of apnoea is prolonged and re-oxygenation is inevitable.Mask ventilation is the most fundamental technique in maintaining oxygenation, even when endotracheal intubation is failed. However, the most common complication of NTI is epistaxis, removing the nasotracheal tube could make mask ventilation extremely difficult.So the investigatorsbelieve the ideal approach is ventilation through original nasotracheal tube.Several techniques of supraglottic ventilations through endotracheal tubes have been reported.It remains uncertain whether supraglottic ventilation through inflated nasal RAE endotracheal tube has similar efficiency as mask ventilation after general anesthesia induction. Based on previous clinical experience, the investigators hypothesised that ventilations through inflated nasal RAE endotracheal tube and through facemask were comparable in terms of tidal volume and airway pressure in anesthetized, apnoeic adults. Forty patients were randomly assigned (sealed envelope method) to face mask（Group A，n=20）or nasal ventilation(Group B，n=20), For A: face mask ventilation followed by nasal ventilation and for B:nasal ventilation followed by face mask ventilation.Measure the tidal volume and air leakage of face mask and nasal ventilation during pressure-controlled ventilation mode and volume-controlled mode, respectively.

Official Title
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A Randomised, Crossover Comparison of Nasal Ventilation vs Face Mask in Anesthetised Adults

Conditions
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Nasotracheal Intubation

Intervention / Treatment
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* Procedure: face mask ventilation crossover nasal ventilation
* Procedure: nasal ventilation crossover face mask ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18-55 years old ASA physical status I and II Requiring general anesthesia with nasal intubation Exclusion Criteria: Respiratory disease，cardiovascular disease, cerebral vascular disease Anticipated Difficult Mask Ventilation(Age>55 years old, obesity,bearded,edentulous,a history of snoring) The need for emergency surgery Contraindications to nasal intubation Pregnancy Gastric-esophageal reflex or a full stomach

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: face mask crossover nasal ventilation<br> | Procedure: face mask ventilation crossover nasal ventilation<br>* Group A was first ventilated through the face mask, and the tidal volume was measured under pressure-controlled mode (10, 15, 20 cm H2O) ;Switched to volume-controlled (6,8,10ml/kg predicted body weight)mode, the actual tidal volume was recorded, and the air leakage was calculated. Then, put a nasal RAE tube in one side of the nostril, inflate the cuff, make the catheter in a natural position after inflation, clip the other side of the nostril, close the lip with tape, connect the breathing circuit, record the actual tidal volume; measure the expired tidal volume during pressure-controlled ventilation (10, 15, 20 cm H2O).Subject will start with one technique and then cross over to the other technique.<br>|
| Active Comparator: nasal ventilation crossover face mask<br> | Procedure: nasal ventilation crossover face mask ventilation<br>* Group B first placed a nasal RAE tube in one side of the nostril, the cuff was inflated, the catheter was in a natural position after inflation, the other side of the nostril was clamped, the lip was closed with tape, the breathing circuit was connected, and the amount of tidal volume was measured under pressure-controlled mode ( 10,15,20cm H2O) ; switch to volume-controlled ventilation mode (6,8,10ml/kg predicted body weight), record the actual tidal volume; pull out the tracheal tube, perform mask ventilation, record the actual tidal volume and tidal volume under volume-controlled mode(6,8,10ml/kg predicted body weight) and pressure-controlled mode (10, 15, 20 cm H2O) , respectively.Subject will start with one technique and then cross over to the other technique.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in expired tidal volume of each technique under pressure-controlled mode |  | 3 breaths of expired tidal volume for each technique | 
| Difference in air leakage of each technique under volume-controlled mode |  | 3 breaths of air leakage for each technique | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with Oxygen Saturation- Reading Below 95% |  | intraoperative duration of each ventilation technique | 
| peak inspiratory pressure |  | intraoperative duration of each ventilation technique | 
| end tidal CO2 partial pressure Reading- Median |  | intraoperative duration of each ventilation technique | 
| hemodynamic changes |  | intraoperative duration of each ventilation technique | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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face mask, nasal ventilation