search
Back to results

Interventional Bronchoscopy Under Noninvasive Ventilation

Primary Purpose

Noninvasive Positive Pressure Ventilation;, Sedation;, Bronchoscopy；

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
invasive ventilation
interventional bronchoscopy
noninvasive ventilation
sedation(dezocine and midazolam)
general anesthesia(midazolam, fentanyl，rocuronium，propofol and Remifentanil）
Sponsored by
Futian People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Noninvasive Positive Pressure Ventilation;

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Futian People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

hypoxemia, central airway stenosis.

hypoxemia, central airway stenosis

Arm 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.

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.

Outcomes

Primary Outcome Measures

The improvement of airway stenosis after the operation
The improvement of partial pressure of arterial oxygen (PaO2) after the operation

Secondary Outcome Measures

hospitalization expenses
hypoxemia during the operation

Full Information

First Posted
August 4, 2014
Last Updated
November 12, 2014
Sponsor
Futian People's Hospital
Collaborators
Science and Technology Innovation Commission of Shenzhen Municipality
search

1. Study Identification

Unique Protocol Identification Number
NCT02289586
Brief Title
Interventional Bronchoscopy Under Noninvasive Ventilation
Official Title
Interventional Bronchoscopy Under Noninvasive Ventilation for Central Airway Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Futian People's Hospital
Collaborators
Science and Technology Innovation Commission of Shenzhen Municipality

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Noninvasive Positive Pressure Ventilation;, Sedation;, Bronchoscopy；, Interventional；, Central Airway Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hypoxemia, central airway stenosis.
Arm Type
Active Comparator
Arm 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.
Arm Title
hypoxemia, central airway stenosis
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
invasive ventilation
Intervention Type
Procedure
Intervention Name(s)
interventional bronchoscopy
Intervention Type
Device
Intervention Name(s)
noninvasive ventilation
Intervention Type
Drug
Intervention Name(s)
sedation(dezocine and midazolam)
Intervention Type
Drug
Intervention Name(s)
general anesthesia(midazolam, fentanyl，rocuronium，propofol and Remifentanil）
Primary Outcome Measure Information:
Title
The improvement of airway stenosis after the operation
Time Frame
1 day
Title
The improvement of partial pressure of arterial oxygen (PaO2) after the operation
Time Frame
1 day
Secondary Outcome Measure Information:
Title
hospitalization expenses
Time Frame
During the period of hospitalization，an expected average of 4 weeks
Title
hypoxemia during the operation
Time Frame
1 day

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao-ke Chen, Master
Phone
+86-755-83982222
Ext
32070
Email
007cxk@163.com
Facility Information:
Facility Name
Futian People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518033
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao-ke Chen, master
Phone
+86-755-83982222
Ext
32070
Email
007cxk@163.com

12. IPD Sharing Statement

Learn more about this trial

Interventional Bronchoscopy Under Noninvasive Ventilation

We'll reach out to this number within 24 hrs