NCT02592122

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Last Updated

October 30, 2015

Status Verified

October 1, 2015

Enrollment Period

3 years

First QC Date

October 11, 2015

Last Update Submit

October 29, 2015

Conditions

Lung Disease,Obstructive

Keywords

Mechanical ventilationChronic obstructive pulmonary diseaseAirway resistanceBronchial dilation test

Outcome Measures

Primary Outcomes (2)

  • airway resistance

    The first test of bronchial dilatation

    1 day

  • Respiratory mechanics index:PEEPi

    1 day

Secondary Outcomes (4)

  • Mechanical ventilation time

    28 days

  • length of hospital stay

    30 days

  • Costs of hospitalization expenses

    30 days

  • Routine blood test:Eosinophilic cells

    7days

Study Arms (2)

Atomization inhalation

ACTIVE COMPARATOR

First of all, investigators need to give patients to do the test, the result is more than 12% is positive group, less than 12% is negative group.Second, randomly selected into the atomization group

Drug: Salbutamol Aerosol

Without atomization inhalation

ACTIVE COMPARATOR

First of all, investigators need to give patients to do the test, the result is more than 12% is positive group, less than 12% is negative group.Secondly, the random selection is not the atomization group

Drug: No drugs

Interventions

Salbutamol AerosolDRUG
Also known as: Ammonium bromide bromide aerosol
Atomization inhalation
No drugsDRUG
Without atomization inhalation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • hours to pull out the tube

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of respiratory and critical care medicine,Beijing Chao-yang Hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

Related 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.

    PMID: 25785124BACKGROUND

MeSH Terms

Conditions

Lung Diseases, ObstructivePulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bing Sun

    Beijing Chao Yang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xue Wang, MB

CONTACT

0086-10-85231543rtxue2013@sina.com

Sun Bing, MD

CONTACT

86013911151075ricusunbing@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR

Study Record Dates

First Submitted

October 11, 2015

First Posted

October 30, 2015

Study Start

October 1, 2013

Primary Completion

October 1, 2016

Last Updated

October 30, 2015

Record last verified: 2015-10

Locations

CN(1)