Bronchodilator Test in Mechanical Ventilated Chronic Obstructive Pulmonary Disease Patients
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Albuterol
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring airway resistance, lung compliance, Duration of mechanical ventilation
Eligibility Criteria
Inclusion Criteria:
should meet all the criteria:
- Acute exacerbated chronic obstructive pulmonary disease
- Invasive mechanical ventilation with intubation outside ICU no more than 48 hours
Exclusion Criteria:
Meet any of the criteria:
- Asthma
- Tracheotomy
- Prolonged Mechanical Ventilation (Have been mechanical ventilated for more than 21 days)
- Unstable hemodynamic status
- Severe pneumonia
- Contraindication for bronchodilator
- Contraindication for sedation
- Refusal to participate in study
- Re-intubation in 48 hours
- Mental disorder, could not understand and accomplish pulmonary function test
Sites / Locations
- Respiratory Intensive Care Unit, Beijing Chaoyang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Bronchodilator
No drug
Arm Description
Albuterol 3-4 times per day, steroids when necessary.
No drug
Outcomes
Primary Outcome Measures
Percentage of 12% Decrease in airway resistance
Secondary Outcome Measures
Duration of mechanical ventilation
Full Information
NCT ID
NCT02218398
First Posted
February 6, 2014
Last Updated
August 15, 2014
Sponsor
Beijing Chao Yang Hospital
Collaborators
First Affiliated Hospital of Chongqing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02218398
Brief Title
Bronchodilator Test in Mechanical Ventilated Chronic Obstructive Pulmonary Disease Patients
Official Title
Bronchodilator Test in Mechanical Ventilated Chronic Obstructive Pulmonary Disease Patients, a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital
Collaborators
First Affiliated Hospital of Chongqing Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Investigators developed a test to assess the bronchodilator effects in mechanically ventilated chronic obstructive pulmonary disease patients by comparing the change of airway resistance. No matter whether patients respond to bronchodilator or not, they are randomized assigned to bronchodilator 3-4 times per day group and no bronchodilator group. Then investigators could objectively decide whether individual patients need or benefit from bronchodilator administration.
Detailed Description
Bronchodilator is commonly used in mechanical ventilated chronic obstructive pulmonary disease patients. It is assumed that patient's response to bronchodilator is the same during acute exacerbation or when stable whether on mechanical ventilation or not. Decision to treat is often independent of response and the patient's response to the medicine is not precisely evaluated. Investigators developed a test to assess the bronchodilator effects in mechanically ventilated chronic obstructive pulmonary disease patients by comparing the change of airway resistance. No matter whether patients respond to bronchodilator or not, they are randomized assigned to bronchodilator 3-4 times per day group and no bronchodilator group. Then investigators could objectively decide whether individual patients need or benefit from bronchodilator administration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
airway resistance, lung compliance, Duration of mechanical ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bronchodilator
Arm Type
Experimental
Arm Description
Albuterol 3-4 times per day, steroids when necessary.
Arm Title
No drug
Arm Type
No Intervention
Arm Description
No drug
Intervention Type
Drug
Intervention Name(s)
Albuterol
Primary Outcome Measure Information:
Title
Percentage of 12% Decrease in airway resistance
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Duration of mechanical ventilation
Time Frame
participants will be followed for the duration of ICU stay, an expected average of 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
should meet all the criteria:
Acute exacerbated chronic obstructive pulmonary disease
Invasive mechanical ventilation with intubation outside ICU no more than 48 hours
Exclusion Criteria:
Meet any of the criteria:
Asthma
Tracheotomy
Prolonged Mechanical Ventilation (Have been mechanical ventilated for more than 21 days)
Unstable hemodynamic status
Severe pneumonia
Contraindication for bronchodilator
Contraindication for sedation
Refusal to participate in study
Re-intubation in 48 hours
Mental disorder, could not understand and accomplish pulmonary function test
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Li, Master
Phone
86-13552976483
Email
lijie8497@hotmail.com
Facility Information:
Facility Name
Respiratory Intensive Care Unit, Beijing Chaoyang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101100
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Li, Master
Phone
86-13552976483
Email
lijie8497@hotmail.com
First Name & Middle Initial & Last Name & Degree
Bing Sun, Master
Phone
86-13911151075
Email
ricusunbing@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Bronchodilator Test in Mechanical Ventilated Chronic Obstructive Pulmonary Disease Patients
We'll reach out to this number within 24 hrs