Using Positive Pressure Ventilation for Preoxygenation During Panendoscopy.

Study Overview
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Brief Summary
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the aim of the study is to determine if Spontaneous Ventilation with Positive Pressure Ventilation (PPV) preoxygenation allows a longer non hypoxemic apnea time during panendoscopy compared to spontaneous breathing preoxygenation. the hypothesis is PPV extends the residual functional capacity of lung so it provides more oxygen during apnea.

Official Title
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Non Invasive Ventilation (NIV) Versus Spontaneous Breathing for Preoxygenation During Ear, Nose, and Throat (ENT) Panendoscopy. A Controlled, Prospective, Randomized Study.

Conditions
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ENT Cancer Screening

Intervention / Treatment
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* Device: positive pressure ventilation
* Procedure: Oxygenation with simple breathing mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient going for scheduled panendoscopy under general anesthesia Exclusion Criteria: BMI upper to 35 kg/m2 pregnancy requirement of jet ventilation tracheostomy acute respiratory failure: pneumonia, pulmonary embolism health insurance careless

Ages Eligible for Study
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Minimum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: positive pressure ventilation<br>Positive Pressure Ventilation with a 4 cmH2O inhale pressure, a positive end-expiratory pressure of 4 cm H2O, a trigger 2, an inspiratory slope of 0, an inhaled oxygen fraction of 100% administered at a 10 L / min flow. | Device: positive pressure ventilation<br>* Positive Pressure Ventilation with a 4 cmH2O inhale pressure, a positive end-expiratory pressure of 4 cm H2O, a trigger 2, an inspiratory slope of 0, an inhaled oxygen fraction of 100% administered at a 10 L / min flow.<br>* Other names: non invasive ventilation (NIV);|
| Active Comparator: Oxygenation with simple breathing mask<br>spontaneously breathing preoxygenation with adapted face mask, to restrict leakage, at 10L/min oxygen, with inhaled fraction of 100% and a 2 L balloon volume. | Procedure: Oxygenation with simple breathing mask<br>* Spontaneously breathing preoxygenation with adapted face mask, to restrict leakage, at 10L/min oxygen, with inhaled fraction of 100% and a 2 L balloon volume.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| non hypoxemic apnea time | time the oxygen saturation is going down to 90% during apnea | up to 5 minutes after stopping oxygenation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical laryngoscopy frequency | number of stopped surgical laryngoscopy because of a low oxygen saturation under 90% with necessity to ventilate the patients during apnea | up to 15 minutes after stopping oxygenation | 
| preoxygenation time | time to reach expired oxygen fraction to 90% | up to 10 min after the start of oxygenation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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panendoscopy, preoxygenation, non invasive ventilation