Bronchodilator Test in Mechanical Ventilated Chronic Obstructive Pulmonary Disease Patients

Capital Medical University

Status: Unknown

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Albuterol

Study type: Interventional

Funder types: Other

Identifiers

NCT02218398

BJCYRT-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Bronchodilator

Experimental group

Description:

Albuterol 3-4 times per day, steroids when necessary.

Treatment:

Drug: Albuterol

No drug

No Intervention group

Description:

No drug