Effects of High-intensity Noninvasive Positive Pressure Ventilation in AECOPD
কীওয়ার্ডস
বিমূর্ত
তারিখ
| সর্বশেষ যাচাই করা হয়েছে: | 09/30/2019 |
| প্রথম জমা দেওয়া: | 05/20/2019 |
| আনুমানিক তালিকাভুক্তি জমা দেওয়া হয়েছে: | 07/31/2019 |
| প্রথম পোস্ট: | 08/04/2019 |
| সর্বশেষ আপডেট জমা দেওয়া হয়েছে: | 10/02/2019 |
| সর্বশেষ আপডেট পোস্ট: | 10/03/2019 |
| আসল অধ্যয়ন শুরুর তারিখ: | 09/29/2019 |
| আনুমানিক প্রাথমিক সমাপ্তির তারিখ: | 09/29/2020 |
| আনুমানিক অধ্যয়ন সমাপ্তির তারিখ: | 12/29/2020 |
অবস্থা বা রোগ
হস্তক্ষেপ / চিকিত্সা
Device: High-intensity NPPV
Device: Low-intensity NPPV
পর্যায়
বাহু গ্রুপ
| বাহু | হস্তক্ষেপ / চিকিত্সা |
|---|---|
| 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. |
যোগ্যতার মানদণ্ড
| বয়স অধ্যয়নের জন্য যোগ্য | 18 Years প্রতি 18 Years |
| লিঙ্গ অধ্যয়নের জন্য যোগ্য | All |
| স্বাস্থ্যকর স্বেচ্ছাসেবীদের গ্রহণ করে | হ্যাঁ |
| নির্ণায়ক | 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 |
ফলাফল
প্রাথমিক ফলাফল ব্যবস্থা
1. PaCO2 measured at 24 hours after enrollment [24 hours]
মাধ্যমিক ফলাফলের ব্যবস্থা
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]
