Effects of High-intensity Noninvasive Positive Pressure Ventilation in AECOPD
Keywords
Abstract
Dates
| Last Verified: | 09/30/2019 |
| First Submitted: | 05/20/2019 |
| Estimated Enrollment Submitted: | 07/31/2019 |
| First Posted: | 08/04/2019 |
| Last Update Submitted: | 10/02/2019 |
| Last Update Posted: | 10/03/2019 |
| Actual Study Start Date: | 09/29/2019 |
| Estimated Primary Completion Date: | 09/29/2020 |
| Estimated Study Completion Date: | 12/29/2020 |
Condition or disease
Intervention/treatment
Device: High-intensity NPPV
Device: Low-intensity NPPV
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: High-intensity NPPV The patients will receive high-intensity noninvasive positive pressure ventilation. | Device: High-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. |
| Active Comparator: Low-intensity NPPV The patients will receive low-intensity noninvasive positive pressure ventilation. | Device: Low-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. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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. pH <7.25 9. Arterial oxygen tension/fraction of inspired oxygen <150 mmHg 10. Pneumothorax 11. Severe ventricular arrhythmia or myocardial ischemia 12. Severe hemodynamic instability despite fluid repletion and use of vasoactive agents 13. Severe metabolic acidosis 14. Refusal to receive NPPV 15. Endotracheal intubation already performed before ICU admission |
Outcome
Primary Outcome Measures
1. PaCO2 measured at 24 hours after enrollment [24 hours]
Secondary Outcome Measures
1. PaCO2 measured at 2 hours after enrollment [2 hours]
2. PaCO2 measured at 6 hours after enrollment [6 hours]
3. PaCO2 measured at 48 hours after enrollment [48 hours]
4. PaCO2 measured at 72 hours after enrollment [72 hours]
5. Glasgow coma scale score [72 hours]
6. ΔPes [72 hours]
7. Dyspnea score [72 hours]
8. NPPV tolerance score [72 hours]
9. Plasma level of TNF-α [72 hours]
10. Plasma level of I-1β [72 hours]
11. Plasma level of IL-6 [72 hours]
12. Plasma level of IL-8 [72 hours]
13. Plasma level of IL-10 [72 hours]
