This study aims to investigate the effects of high-intensity noninvasive positive pressure ventilation (NPPV), as compared with low-intensity NPPV, on hypercapnia, consciousness, inspiratory muscle effort, dyspnea, NPPV tolerance, inflammatory response, adverse events and other outcomes in patients with acute exacerbation of chronic obstructive pulmonary disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
In the high-intensity NPPV group, patients will undergo pressure-limited NPPV (eg, NPPV in spontaneous/timed mode) at a higher IPAP level. IPAP is initially set at 10 cmH2O and continuously adjusted by increments and decrements of 1-2 cmH2O (typically ranging between 20 and 30 cmH2O), according to patients' tolerance, to obtain a tidal volume (VT) of 10-15 mL/kg. IPAP should be increased as much as possible to decrease PaCO2 to a normal level. However, if PaCO2 decreases to less than 35 mmHg, IPAP should be decreased to achieve normocapnia.
In the low-intensity NPPV group, patients will undergo pressure-limited NPPV (eg, NPPV in spontaneous/timed mode) with a conventional IPAP level. IPAP is initially set to 10 cmH2O and is continuously adjusted by increments and decrements of 1-2 cmH2O (up to 20 cmH2O), according to patients' tolerance, to obtain a VT of 6-10 mL/kg.
Beijing Chao-Yang Hospital
Beijing, China
PaCO2 measured at 24 hours after enrollment
PaCO2 measured at 24 hours after enrollment.
Time frame: 24 hours
PaCO2 measured at 2 hours after enrollment
PaCO2 measured at 2 hours after enrollment
Time frame: 2 hours
PaCO2 measured at 6 hours after enrollment
PaCO2 measured at 6 hours after enrollment
Time frame: 6 hours
PaCO2 measured at 48 hours after enrollment
PaCO2 measured at 48 hours after enrollment
Time frame: 48 hours
PaCO2 measured at 72 hours after enrollment
PaCO2 measured at 72 hours after enrollment
Time frame: 72 hours
Glasgow coma scale score
The glasgow coma scale score, ranging from 3 (coma) to 15 (normal consciousness), will be used to assess the consciousness level.
Time frame: 72 hours
ΔPes
Inspiratory esophageal pressure swing
Time frame: 72 hours
Dyspnea score
The dyspnea score will be assessed using a verbal analogue scale with levels from 0 (no dyspnea) to 10 (maximum dyspnea).
Time frame: 72 hours
NPPV tolerance score
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NPPV tolerance will be recorded on a 4-point scale and then dichotomized into acceptable (score of 2 or 3) or poor (score of 0 or 1) tolerance.
Time frame: 72 hours
Plasma level of TNF-α
Plasma level of TNF-α
Time frame: 72 hours
Plasma level of I-1β
Plasma level of IL-1β
Time frame: 72 hours
Plasma level of IL-6
Plasma level of IL-6
Time frame: 72 hours
Plasma level of IL-8
Plasma level of IL-8
Time frame: 72 hours
Plasma level of IL-10
Plasma level of IL-10
Time frame: 72 hours