Interventional Bronchoscopy Under Noninvasive Ventilation

Not Applicable

• Conditions: Sedation; Bronchoscopy； Interventional； Noninvasive Positive Pressure Ventilation; Central Airway Stenosis
• Interventions: Procedure: invasive ventilation; Procedure: interventional bronchoscopy; Device: noninvasive ventilation; Drug: sedation(dezocine and midazolam); Drug: general anesthesia(midazolam, fentanyl，rocuronium，propofol and Remifentanil）

• Registration Number: NCT02289586
• Lead Sponsor: Futian People's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Status Verified: 2014-08
• Study First Submitted: 2014-08-04
• Study First Submitted QC: 2014-11-12
• Last Update Submitted: 2014-11-12
• Study First Posted: 2014-11-13
• Last Update Posted: 2014-11-13
• Primary Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hypoxemia, central airway stenosis.	invasive ventilation	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.
hypoxemia, central airway stenosis	interventional bronchoscopy	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.
hypoxemia, central airway stenosis.	interventional bronchoscopy	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.
hypoxemia, central airway stenosis	sedation(dezocine and midazolam)	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.
hypoxemia, central airway stenosis.	general anesthesia(midazolam, fentanyl，rocuronium，propofol and Remifentanil）	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.
hypoxemia, central airway stenosis	noninvasive ventilation	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.

Primary Outcome Measures

Name	Time	Method
The improvement of partial pressure of arterial oxygen (PaO2) after the operation	1 day
The improvement of airway stenosis after the operation	1 day

Secondary Outcome Measures

Name	Time	Method
hypoxemia during the operation	1 day
hospitalization expenses	During the period of hospitalization，an expected average of 4 weeks

Trial Locations

Locations (1)

Futian People's Hospital; 🇨🇳 Shenzhen, Guangdong, China