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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02592122
Other study ID # 2013-10-COPD
Secondary ID
Status Recruiting
Phase N/A
First received October 11, 2015
Last updated October 29, 2015
Start date October 2013

Study information

Verified date October 2015
Source Beijing Chao Yang Hospital
Contact Xue Wang, MB
Phone 0086-10-85231543
Email rtxue2013@sina.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

In the patients with COPD mechanical ventilation, the bronchial dilatation is very common. However, the evaluation of the efficacy of the medical examination and other subjective indicators, such as doctors, depends on the doctor's experience; at present, there is no objective evaluation index. For patients with mechanical ventilation, the risk of cross infection can not only increase the risk of cross infection, but also increase the workload of clinical doctors and nurses. Therefore, this study proposes an objective evaluation method to evaluate the response of COPD patients to bronchial dilation. The hypothesis of this study can be used to guide the clinical medication through the test of the bronchus. If the patients with bronchial dilation test positive were used in the test, the patients were not used. In this evaluation method, the changes of airway resistance were measured by the accurate measurement of the patients with inhaled bronchial dilatation.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Acute exacerbation of chronic obstructive pulmonary disease

- The mechanical ventilation time of the outdoor endotracheal intubation in the intensive care unit was less than 48 hours

Exclusion Criteria:

- asthma

- has received tracheotomy

- long term mechanical ventilation (which has been accepted for more than 21 days).

- severe pneumonia

- Patients who cannot use a patient with bronchial dilation

- there's a taboo on the use of a sedative.

- refusal to participate in the study

- 48 hours to pull out the tube

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Salbutamol Aerosol

No drugs


Locations

Country Name City State
China Department of respiratory and critical care medicine,Beijing Chao-yang Hospital Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
snow Primary-investigator,Bing Sun

Country where clinical trial is conducted

China, 

References & Publications (1)

Li Y, Chen Y, Wang P. Application of impulse oscillometry and bronchial dilation test for analysis in patients with asthma and chronic obstructive pulmonary disease. Int J Clin Exp Med. 2015 Jan 15;8(1):1271-5. eCollection 2015. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary airway resistance The first test of bronchial dilatation 1 day No
Primary Respiratory mechanics index:PEEPi 1 day No
Secondary Mechanical ventilation time 28 days Yes
Secondary length of hospital stay 30 days Yes
Secondary Costs of hospitalization expenses 30 days No
Secondary Routine blood test:Eosinophilic cells 7days No