NCT04044625

Effects of High-intensity Noninvasive Positive Pressure Ventilation in AECOPD

Effects of High-intensity Versus Low-intensity Noninvasive Positive Pressure Ventilation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Beijing Chao Yang Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2019-09-30
• Primary completion: 2021-03-19
• Completion: 2021-06-16
• First posted: 2019-08-05
• Last updated: 2022-05-10

Locations

1 site across 1 country: China