Bronchodilator Test in Mechanical Ventilated Chronic Obstructive Pulmonary Disease Patients

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Albuterol

• Registration Number: NCT02218398
• Lead Sponsor: Beijing Chao Yang Hospital

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2014-02-06
• Status Verified: 2014-08
• Study First Submitted QC: 2014-08-15
• Last Update Submitted: 2014-08-15
• Study First Posted: 2014-08-18
• Last Update Posted: 2014-08-18
• Primary Completion: 2015-06
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bronchodilator	Albuterol	Albuterol 3-4 times per day, steroids when necessary.

Primary Outcome Measures

Name	Time	Method
Percentage of 12% Decrease in airway resistance	30 minutes

Secondary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation	participants will be followed for the duration of ICU stay, an expected average of 28 days

Trial Locations

Locations (1)

Respiratory Intensive Care Unit, Beijing Chaoyang Hospital; 🇨🇳 Beijing, Beijing, China