Interventional Bronchoscopy Under Noninvasive Ventilation

Study Overview
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Brief Summary
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To evaluate the effect and safety of noninvasive ventilation assisted interventional bronchoscopy for hypoxemia patients with central airway stenosis. With the sedation and analgesia, noninvasive ventilation assisted interventional bronchoscopy for hypoxemia patients with central airway stenosis is safe and effective, carries high satisfaction rate.

Official Title
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Interventional Bronchoscopy Under Noninvasive Ventilation for Central Airway Stenosis

Conditions
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Noninvasive Positive Pressure Ventilation;, Sedation;, Bronchoscopy；, Interventional；, Central Airway Stenosis

Intervention / Treatment
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* Procedure: invasive ventilation
* Procedure: interventional bronchoscopy
* Device: noninvasive ventilation
* Drug: sedation(dezocine and midazolam)
* Drug: general anesthesia(midazolam, fentanyl，rocuronium，propofol and Remifentanil）


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (a)patients with central airway stenosis need interventional bronchoscopy. (b) partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 300; Exclusion Criteria: (a) facial deformity sufficient to preclude mask fitting; (b) upper gastrointestinal bleeding; (c) upper airway obstruction; (d) acute coronary syndromes; (e) tracheostomy or endotracheal intubation(ETI) before admission; (f) need for urgent ETI due to cardiac or respiratory arrest.
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: hypoxemia, central airway stenosis.<br>Inclusion Criteria: (a)patients with central airway stenosis need interventional bronchoscopy (b) partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 300; Exclusion Criteria: (a) facial deformity sufficient to preclude mask fitting; (b) upper gastrointestinal bleeding; (c) upper airway obstruction; (d) acute coronary syndromes; (e) tracheostomy or endotracheal intubation(ETI) before admission; (f) need for urgent ETI due to cardiac or respiratory arrest. | Procedure: invasive ventilation<br> <br> Procedure: interventional bronchoscopy<br> <br> Drug: general anesthesia(midazolam, fentanyl，rocuronium，propofol and Remifentanil）<br> <br> |
| Experimental: hypoxemia, central airway stenosis<br>Inclusion Criteria: (a)patients with central airway stenosis need interventional bronchoscopy (b) partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 300; Exclusion Criteria: (a) facial deformity sufficient to preclude mask fitting; (b) upper gastrointestinal bleeding; (c) upper airway obstruction; (d) acute coronary syndromes; (e) tracheostomy or endotracheal intubation(ETI) before admission; (f) need for urgent ETI due to cardiac or respiratory arrest. | Procedure: interventional bronchoscopy<br> <br> Device: noninvasive ventilation<br> <br> Drug: sedation(dezocine and midazolam)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The improvement of airway stenosis after the operation |  | 1 day | 
| The improvement of partial pressure of arterial oxygen (PaO2) after the operation |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospitalization expenses |  | During the period of hospitalization，an expected average of 4 weeks | 
| hypoxemia during the operation |  | 1 day |