Bronchodilator Test in Mechanical Ventilated Chronic Obstructive Pulmonary Disease Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Bronchodilator Test in Mechanical Ventilated Chronic Obstructive Pulmonary Disease Patients, a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02218398
• Other study ID #: BJCYRT-002
• Status: Recruiting
• Phase: N/A
• First received: February 6, 2014
• Last updated: August 15, 2014
• Start date: May 2013
• Est. completion date: December 2015

Study information

• Verified date: August 2014
• Source: Beijing Chao Yang Hospital
• Contact: Jie Li, Master
• Phone: 86-13552976483
• Email: lijie8497[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

should meet all the criteria:

1. Acute exacerbated chronic obstructive pulmonary disease

2. Invasive mechanical ventilation with intubation outside ICU no more than 48 hours

Exclusion Criteria:

Meet any of the criteria:

1. Asthma

2. Tracheotomy

3. Prolonged Mechanical Ventilation (Have been mechanical ventilated for more than 21 days)

4. Unstable hemodynamic status

5. Severe pneumonia

6. Contraindication for bronchodilator

7. Contraindication for sedation

8. Refusal to participate in study

9. Re-intubation in 48 hours

10. Mental disorder, could not understand and accomplish pulmonary function test

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Albuterol

Locations

Country	Name	City	State
China	Respiratory Intensive Care Unit, Beijing Chaoyang Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital	First Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of 12% Decrease in airway resistance		30 minutes	No
Secondary	Duration of mechanical ventilation		participants will be followed for the duration of ICU stay, an expected average of 28 days	No