Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Individualized Dosing Schedule of Inhaled Bronchodilator for Endotracheally Intubated Chronic Obstructive Pulmonary Disease Patients
Verified date | July 2020 |
Source | Changhua Christian Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates whether individualized dosing schedule of inhaled bronchodilator is more effective than fixed dosing in reducing airway resistance of intubated COPD patients.
Status | Completed |
Enrollment | 51 |
Est. completion date | January 31, 2019 |
Est. primary completion date | January 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - chronic obstructive pulmonary disease - acute respiratory failure under ventilator support for less than 72 hours - endotracheal tube inserted Exclusion Criteria: - confirmed asthma - Acute Physiology and Chronic Health Evaluation II score over 35 - a co-morbidity of septic shock |
Country | Name | City | State |
---|---|---|---|
China | Changhua Christian Hospital | Changhua | Taiwan |
Lead Sponsor | Collaborator |
---|---|
Shin-hwar Wu |
China,
Aerosol consensus statement. Consensus Conference on Aerosol Delivery. Chest. 1991 Oct;100(4):1106-9. Review. — View Citation
Dhand R, Duarte AG, Jubran A, Jenne JW, Fink JB, Fahey PJ, Tobin MJ. Dose-response to bronchodilator delivered by metered-dose inhaler in ventilator-supported patients. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):388-93. — View Citation
Fuller HD, Dolovich MB, Posmituck G, Pack WW, Newhouse MT. Pressurized aerosol versus jet aerosol delivery to mechanically ventilated patients. Comparison of dose to the lungs. Am Rev Respir Dis. 1990 Feb;141(2):440-4. — View Citation
Malliotakis P, Linardakis M, Gavriilidis G, Georgopoulos D. Duration of salmeterol-induced bronchodilation in mechanically ventilated chronic obstructive pulmonary disease patients: a prospective clinical study. Crit Care. 2008;12(6):R140. doi: 10.1186/cc7117. Epub 2008 Nov 14. — View Citation
Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, Janecek E, Domecq C, Greenblatt DJ. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981 Aug;30(2):239-45. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ?Raw (the Difference Between Measured and Target Airway Resistance) | The value can be expressed as relative deviation from target =(measured Raw - target Raw)/target Raw X100 | Airway resistance will be recorded everyday. If a patient's ventilator was liberated less than 28 days, the day of liberation was the reported time frame. If the day of ventilator liberation was over 28 days, the 28th day was the reported time frame. | |
Primary | Rapidity of ?Raw Change | The deviation of ?Raw from the personal target, which was calculated as (measured Raw-target Raw)/target Raw multiplied by 100. | Airway resistance will be recorded everyday. If a patient's ventilator was liberated less than 28 days, the day of liberation was the reported time frame. If the day of ventilator liberation was over 28 days, the 28th day was the reported time frame. | |
Secondary | Ventilator-free Days From Day 1 to 28 | Ventilator-free days from day 1 to 28 after enrollment | From day 1 to day 28 after enrollment | |
Secondary | The Participants of Breathing Without Assistance by Day 28 | The number of participants who breath without ventilator by day 28 | the 28th day after enrollment | |
Secondary | Number of Episode of Nosocomial Pneumonia | The number of episodes of nosocomial pneumonia happened by day 28. And nosocomial pneumonia is a lower respiratory infection that was not incubating at the time of hospital admission and that presents clinically 2 or more days after hospitalization. | the 28th day after enrollment | |
Secondary | Number of Total Puff of Rescue Short-acting Bronchodilator | The number of total puff of rescue short-acting bronchodilator. | the 28th day after enrollment | |
Secondary | Numbers of Episode of Drug-related Adverse Effect | The numbers of episode of drug-related adverse effect. Naranjo score should be over 4 to be considered drug-related adverse effect. Naranjo score range form 0 to 9, and the higher scores means a higher relationship with drug-related adverse effect. | From day 1 to day 28 after enrollment | |
Secondary | Mortality Rate | The percentage of participants died at day 180. | the 180th day after enrollment |
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