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Airway Responsiveness in Patients With AECOPD Mechanical Ventilation by Inspiratory and Bronchial Dilation Testchronic Obstructive Pulmonary Disease

Primary Purpose

Lung Disease,Obstructive

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Salbutamol Aerosol
No drugs
Sponsored by
snow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Disease,Obstructive focused on measuring Mechanical ventilation, Chronic obstructive pulmonary disease, Airway resistance, Bronchial dilation test

Eligibility Criteria

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

Inclusion Criteria:

  • Acute exacerbation of chronic obstructive pulmonary disease
  • The mechanical ventilation time of the outdoor endotracheal intubation in the intensive care unit was less than 48 hours

Exclusion Criteria:

  • asthma
  • has received tracheotomy
  • long term mechanical ventilation (which has been accepted for more than 21 days).
  • severe pneumonia
  • Patients who cannot use a patient with bronchial dilation
  • there's a taboo on the use of a sedative.
  • refusal to participate in the study
  • 48 hours to pull out the tube

Sites / Locations

  • Department of respiratory and critical care medicine,Beijing Chao-yang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Atomization inhalation

Without atomization inhalation

Arm Description

First of all, investigators need to give patients to do the test, the result is more than 12% is positive group, less than 12% is negative group.Second, randomly selected into the atomization group

First of all, investigators need to give patients to do the test, the result is more than 12% is positive group, less than 12% is negative group.Secondly, the random selection is not the atomization group

Outcomes

Primary Outcome Measures

airway resistance
The first test of bronchial dilatation
Respiratory mechanics index:PEEPi

Secondary Outcome Measures

Mechanical ventilation time
length of hospital stay
Costs of hospitalization expenses
Routine blood test:Eosinophilic cells

Full Information

First Posted
October 11, 2015
Last Updated
October 29, 2015
Sponsor
snow
Collaborators
Primary-investigator,Bing Sun
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1. Study Identification

Unique Protocol Identification Number
NCT02592122
Brief Title
Airway Responsiveness in Patients With AECOPD Mechanical Ventilation by Inspiratory and Bronchial Dilation Testchronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
snow
Collaborators
Primary-investigator,Bing Sun

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In the patients with COPD mechanical ventilation, the bronchial dilatation is very common. However, the evaluation of the efficacy of the medical examination and other subjective indicators, such as doctors, depends on the doctor's experience; at present, there is no objective evaluation index. For patients with mechanical ventilation, the risk of cross infection can not only increase the risk of cross infection, but also increase the workload of clinical doctors and nurses. Therefore, this study proposes an objective evaluation method to evaluate the response of COPD patients to bronchial dilation. The hypothesis of this study can be used to guide the clinical medication through the test of the bronchus. If the patients with bronchial dilation test positive were used in the test, the patients were not used. In this evaluation method, the changes of airway resistance were measured by the accurate measurement of the patients with inhaled bronchial dilatation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Disease,Obstructive
Keywords
Mechanical ventilation, Chronic obstructive pulmonary disease, Airway resistance, Bronchial dilation test

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Atomization inhalation
Arm Type
Active Comparator
Arm Description
First of all, investigators need to give patients to do the test, the result is more than 12% is positive group, less than 12% is negative group.Second, randomly selected into the atomization group
Arm Title
Without atomization inhalation
Arm Type
Active Comparator
Arm Description
First of all, investigators need to give patients to do the test, the result is more than 12% is positive group, less than 12% is negative group.Secondly, the random selection is not the atomization group
Intervention Type
Drug
Intervention Name(s)
Salbutamol Aerosol
Other Intervention Name(s)
Ammonium bromide bromide aerosol
Intervention Type
Drug
Intervention Name(s)
No drugs
Primary Outcome Measure Information:
Title
airway resistance
Description
The first test of bronchial dilatation
Time Frame
1 day
Title
Respiratory mechanics index:PEEPi
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Mechanical ventilation time
Time Frame
28 days
Title
length of hospital stay
Time Frame
30 days
Title
Costs of hospitalization expenses
Time Frame
30 days
Title
Routine blood test:Eosinophilic cells
Time Frame
7days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute exacerbation of chronic obstructive pulmonary disease The mechanical ventilation time of the outdoor endotracheal intubation in the intensive care unit was less than 48 hours Exclusion Criteria: asthma has received tracheotomy long term mechanical ventilation (which has been accepted for more than 21 days). severe pneumonia Patients who cannot use a patient with bronchial dilation there's a taboo on the use of a sedative. refusal to participate in the study 48 hours to pull out the tube
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xue Wang, MB
Phone
0086-10-85231543
Email
rtxue2013@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sun Bing, MD
Phone
86013911151075
Email
ricusunbing@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bing Sun
Organizational Affiliation
Beijing Chao Yang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of respiratory and critical care medicine,Beijing Chao-yang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xue Wang, MB
Phone
0086-10-85231543
Email
rtxue2013@sina.com
First Name & Middle Initial & Last Name & Degree
Bing Sun, MD
Phone
86013911151075
Email
ricusunbing@126.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
25785124
Citation
Li Y, Chen Y, Wang P. Application of impulse oscillometry and bronchial dilation test for analysis in patients with asthma and chronic obstructive pulmonary disease. Int J Clin Exp Med. 2015 Jan 15;8(1):1271-5. eCollection 2015.
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Airway Responsiveness in Patients With AECOPD Mechanical Ventilation by Inspiratory and Bronchial Dilation Testchronic Obstructive Pulmonary Disease

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