Interventional Bronchoscopy Under Noninvasive Ventilation

Interventional Bronchoscopy Under Noninvasive Ventilation for Central Airway Stenosis

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiao-ke Chen, master; Phone Number: 32070 +86-755-83982222; Email: 007cxk@163.com

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518033
      • Recruiting
      • Futian People's Hospital
      • Contact: Xiao-ke Chen, master; Phone Number: 32070 +86-755-83982222; Email: 007cxk@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Futian People's Hospital
• Collaborators: Science and Technology Innovation Commission of Shenzhen Municipality

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): February 1, 2016

Study Registration Dates

• First Submitted: August 4, 2014
• First Submitted That Met QC Criteria: November 12, 2014
• First Posted (Estimate): November 13, 2014

Study Record Updates

• Last Update Posted (Estimate): November 13, 2014
• Last Update Submitted That Met QC Criteria: November 12, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Remifentanil; Fentanyl; Midazolam; Propofol; Rocuronium; Dezocine
• Other Study ID Numbers: szkcw-2014-322