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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-intensity NPPV | Experimental | The patients will receive high-intensity noninvasive positive pressure ventilation. |
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| Low-intensity NPPV | Active Comparator | The patients will receive low-intensity noninvasive positive pressure ventilation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-intensity NPPV | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PaCO2 measured at 24 hours after enrollment | PaCO2 measured at 24 hours after enrollment. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| PaCO2 measured at 2 hours after enrollment | PaCO2 measured at 2 hours after enrollment | 2 hours |
| PaCO2 measured at 6 hours after enrollment | PaCO2 measured at 6 hours after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zujin Luo, MD | Beijing Chao Yang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chao-Yang Hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35587843 | Derived | Luo Z, Cao Z, Li Y, Jin J, Sun W, Zhu J, Zhao N, Liu J, Wei B, Hu Y, Zhang Y, Ma Y, Wang C. Physiological effects of high-intensity versus low-intensity noninvasive positive pressure ventilation in patients with acute exacerbation of chronic obstructive pulmonary disease: a randomised controlled trial. Ann Intensive Care. 2022 May 19;12(1):41. doi: 10.1186/s13613-022-01018-4. |
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| Low-intensity NPPV | Device | 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. |
|
| 6 hours |
| PaCO2 measured at 48 hours after enrollment | PaCO2 measured at 48 hours after enrollment | 48 hours |
| PaCO2 measured at 72 hours after enrollment | PaCO2 measured at 72 hours after enrollment | 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. | 72 hours |
| ΔPes | Inspiratory esophageal pressure swing | 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). | 72 hours |
| NPPV tolerance score | 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. | 72 hours |
| Plasma level of TNF-α | Plasma level of TNF-α | 72 hours |
| Plasma level of I-1β | Plasma level of IL-1β | 72 hours |
| Plasma level of IL-6 | Plasma level of IL-6 | 72 hours |
| Plasma level of IL-8 | Plasma level of IL-8 | 72 hours |
| Plasma level of IL-10 | Plasma level of IL-10 | 72 hours |