Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
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.
Interventions
DEVICEHigh-intensity NPPV
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.
DEVICELow-intensity NPPV
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.
Sponsors
Beijing Chao Yang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of COPD according to the criteria of the Global Initiative for Chronic Obstructive Lung Disease in 2019 2. Presence of acute exacerbation 3. Arterial pH \<7.35 with arterial carbon dioxide tension (PaCO2) \>45 mmHg on room air or supplemental oxygen 4. PaCO2 \>45 mmHg following low-intensity NPPV of ≥6 hours
Exclusion criteria
1. Age \<18 years 2. Excessive amount of respiratory secretions or weak cough 3. Upper airway obstruction 4. Recent oral, facial, or cranial trauma or surgery; recent gastric or esophageal surgery 5. Potential risk factors for restrictive ventilatory dysfunction (eg, consolidation or removal of at least one pulmonary lobe, massive pleural effusion, chest wall deformity, continuous strapping with thoracic or abdominal bandage, and severe abdominal distention) 6. Active upper gastrointestinal bleeding 7. Cardiac or respiratory arrest 8. Arterial oxygen tension/fraction of inspired oxygen \<100 mmHg 9. Pneumothorax 10. Severe ventricular arrhythmia or myocardial ischemia 11. Severe hemodynamic instability despite fluid repletion and use of vasoactive agents 12. Severe metabolic acidosis 13. Refusal to receive NPPV 14. Endotracheal intubation already performed before ICU admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PaCO2 measured at 24 hours after enrollment | 24 hours | PaCO2 measured at 24 hours after enrollment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PaCO2 measured at 6 hours after enrollment | 6 hours | PaCO2 measured at 6 hours after enrollment |
| PaCO2 measured at 48 hours after enrollment | 48 hours | PaCO2 measured at 48 hours after enrollment |
| PaCO2 measured at 72 hours after enrollment | 72 hours | PaCO2 measured at 72 hours after enrollment |
| Glasgow coma scale score | 72 hours | The glasgow coma scale score, ranging from 3 (coma) to 15 (normal consciousness), will be used to assess the consciousness level. |
| ΔPes | 72 hours | Inspiratory esophageal pressure swing |
| Dyspnea score | 72 hours | The dyspnea score will be assessed using a verbal analogue scale with levels from 0 (no dyspnea) to 10 (maximum dyspnea). |
| PaCO2 measured at 2 hours after enrollment | 2 hours | PaCO2 measured at 2 hours after enrollment |
| Plasma level of TNF-α | 72 hours | Plasma level of TNF-α |
| Plasma level of I-1β | 72 hours | Plasma level of IL-1β |
| Plasma level of IL-6 | 72 hours | Plasma level of IL-6 |
| Plasma level of IL-8 | 72 hours | Plasma level of IL-8 |
| Plasma level of IL-10 | 72 hours | Plasma level of IL-10 |
| NPPV tolerance score | 72 hours | 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. |
Countries
China
Outcome results
None listed