Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bronchodilator Test in Mechanical Ventilated Chronic Obstructive Pulmonary Disease Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02218398
Recruitment Status : Unknown
Verified August 2014 by Jie Li, Beijing Chao Yang Hospital.
Recruitment status was:  Recruiting
First Posted : August 18, 2014
Last Update Posted : August 18, 2014
Sponsor:
Collaborator:
First Affiliated Hospital of Chongqing Medical University
Information provided by (Responsible Party):
Jie Li, 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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Albuterol Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Bronchodilator Test in Mechanical Ventilated Chronic Obstructive Pulmonary Disease Patients, a Randomized Controlled Trial
Study Start Date : May 2013
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Bronchodilator
Albuterol 3-4 times per day, steroids when necessary.
Drug: Albuterol
No Intervention: No drug
No drug



Primary Outcome Measures :
  1. Percentage of 12% Decrease in airway resistance [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. Duration of mechanical ventilation [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 28 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02218398


Contacts
Layout table for location contacts
Contact: Jie Li, Master 86-13552976483 lijie8497@hotmail.com

Locations
Layout table for location information
China, Beijing
Respiratory Intensive Care Unit, Beijing Chaoyang Hospital Recruiting
Beijing, Beijing, China, 101100
Contact: Jie Li, Master    86-13552976483    lijie8497@hotmail.com   
Contact: Bing Sun, Master    86-13911151075    ricusunbing@gmail.com   
Sponsors and Collaborators
Beijing Chao Yang Hospital
First Affiliated Hospital of Chongqing Medical University
Layout table for additonal information
Responsible Party: Jie Li, RRT-NPS, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT02218398    
Other Study ID Numbers: BJCYRT-002
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: August 18, 2014
Last Verified: August 2014
Keywords provided by Jie Li, Beijing Chao Yang Hospital:
airway resistance
lung compliance
Duration of mechanical ventilation
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action