Interventional Bronchoscopy Under Noninvasive Ventilation

Overview

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.

Full Title of Study: “Interventional Bronchoscopy Under Noninvasive Ventilation for Central Airway Stenosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2016

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: hypoxemia, central airway stenosis.
    • 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.
  • Experimental: hypoxemia, central airway stenosis
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • The improvement of airway stenosis after the operation
    • Time Frame: 1 day
  • The improvement of partial pressure of arterial oxygen (PaO2) after the operation
    • Time Frame: 1 day

Secondary Measures

  • hospitalization expenses
    • Time Frame: During the period of hospitalization,an expected average of 4 weeks
  • hypoxemia during the operation
    • Time Frame: 1 day

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Futian People’s Hospital
  • Collaborator
    • Science and Technology Innovation Commission of Shenzhen Municipality
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Xiao-ke Chen, Master, +86-755-83982222, 007cxk@163.com

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