Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Individualized Dosing Schedule of Inhaled Bronchodilator for Endotracheally Intubated Chronic Obstructive Pulmonary Disease Patients
This study evaluates whether individualized dosing schedule of inhaled bronchodilator is more effective than fixed dosing in reducing airway resistance of intubated COPD patients.
*Study Design
- This is an open-label, randomized controlled study comparing individualized versus fixed
bronchodilator dosing schedule for patients with COPD with acute respiratory failure.
*Patients Enrollment
- We will collect 100 patients just admitted to the intensive care unit of Changhua
Christian Hospital (Changhua, Taiwan) due to COPD with acute respiratory failure.All
participants will be randomly assigned to either group according to a computer-generated
allocation sequence in block size of 4 patients.
*Airway Resistance (Raw) Determination
- Enrolled patients will be ventilated by either AVEA (CareFusion, Yorba Linda, CA,
USA),e500 (Newport Medical Instrument Inc. CA, USA) or Eivta 4 (Drager) ventilator. When
evaluating Raw, the ventilator settings will be transiently switched to volume control
mode with fixed tidal volume (500 ml) and constant flow (with a rate of 60 L/min).
Plateau pressure is measured by manually controlled end-inspiratory pause12. Every
effort will be exercised to avoid excessive airway secretion or patient agitation during
measurement. Each measurement will be repeated three times with an interval of at lease
1 minute and calculate their average. Raw will be calculated by an equation of (peak
inspiratory pressure - plateau pressure)/flow. After each measurement, the ventilator
will soon be reverted to its usual settings. Raw will be routinely determined every 8
hours for 28 days if the ventilator is not discontinued.
*Technique of Metered Dose Inhaler (MDI) administration through endotracheal tube
- The technique basically follows the recommendation of Dhand and Guntur. Airway
secretions should be sucked out before drug administration. Heat moisture exchanger, but
not humidifier, is removed. After shaking and warming MDI to hand temperature, the
canister is connected to an AeroChamber HC MV spacer (Trudell Medical International,
London, Canada) placed in the inspiratory limb of ventilator circuit 15 cm away from the
endotracheal tube. Actuation is synchronized with the initiation of inspiration. Each
actuation is at least 15 second apart.
*Personal Target Raw Determination
- The target Raw of each patient should be determined within 72 hours after their
admission to intensive care unit. After confirming no inhaled bronchodilator given in
preceding 2 hours (for fenoterol) or 12 hours (for salmeterol/fluticasone), we will
deliver 3 consecutive doses of 4 puffs, 8 puffs and 16 puffs of fenoterol MDI (100
mcg/puff, Berotec;Boehringer Ingelheim, Ingelheim, Germany) inhalation with each dose 15
minutes apart. The Raw measured 15 minutes later is assigned as this patient's personal
target Raw.
*Bronchodilator Delivery Schedule
- Each patient will routinely receive 4 puffs of 25 mcg salmeterol /250 mcg fluticasone
(Seretide Evohaler 250; GlaxoSmithKline Inc. Evreux, France) every 12 hours until the
discontinuation of ventilator. Each patient will also routinely receive 1 vial of
Combivent (ipatropium bromide 0.5 mg and salbutamol sulfate 2.5 mg) every 6 hours and be
injected with intravenous methylprednisolone 40mg every 8 hours in the initial 3
days.The use of short acting bronchodilator in an as-needed basis is not restricted.
According to the Raw data determined every 8 hours, individualized dosing group will
receive an additional 4 puffs of 25 mcg salmeterol /250 mcg fluticasone plus 4 puffs of
fenoterol if the value is higher than personal target Raw (Once it coincides with
regular dosing period of salmeterol/fluticasone, only fenoterol will be added). No such
extra dose will be given to fixed dosing (control) group regardless of Raw value.
*Statistical Analysis
- Student's t test will be used to compare ∆Raw of both groups. For the comparisons of
other continuous variables without distribution normality, Wilcoxon rank sum test will
be used. When comparing two categorical variables, Chi-square or Fisher's exact test
will be used when appropriate. A P value of less than 0.05 is considered significant.
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