Clinical trial NCT02218398: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: airway resistance
lung compliance
Duration of mechanical ventilation
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Chongqing Medical University
First posted: 2014-08-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of 12% Decrease in airway resistance
timeFrame: 30 minutes
Secondary outcomes:
measure: Duration of mechanical ventilation
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 28 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Respiratory Intensive Care Unit, Beijing Chaoyang Hospital
state: Beijing
Study officials:
References: