NCT06692023

Impact of HI-NPPV Vs LI-NPPV on Tolerance Among AECOPD Patients

Impact of High-Intensity-NIV Vs Low-intensity-NIV on Subjective Tolerance Amomg Patients with AECOPD : a Randomised Cross-over Pilot Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Beijing Chao Yang Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine whether high-intensity NPPV, compared with low-intensity NPPV, could have an effect on the subjective tolerance in patients with an AECOPD and hypercapnia.

Detailed description

To evaluate the subjective tolerance of high-intensity NPPV and low-intensity NPPV patients in a conscious state by two questionnaire surveys; To assess tolerance of high-intensity NPPV and low-intensity NPPV patients patient in sleeping status by PSG monitoring.

Conditions

• Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DEVICE	High-intensity NPPV	In the high-intensity NPPV group, IPAP is initially adjusted in increments/decrements of 1-2 cmH2O, typically ranging from 20 to 30 cmH2O (or a tolerated maximum), to obtain a VT 10-15 mL/kg PBW and a respiratory rate \<25 breaths/min. Subsequent adjustments to IPAP are based on the results of arterial blood gases (ABGs; up to 30 cmH2O) to achieve normocapnia (if possible), or to maximally decrease PaCO2 toward normocapnia if normocapnia can not be achieved. If PaCO2 decreases to less than 35 mmHg, IPAP will be decreased to achieve normocapnia.
DEVICE	Low-intensity NPPV	In the low-intensity NPPV group, as well as during the 6-hour trial of low-intensity NPPV, IPAP is initially adjusted in increments/decrements of 1-2 cmH2O (up to 20 cmH2O), according to patients' tolerance, to obtain a VT 6-10 mL/kg PBW and a respiratory rate \<25 breaths/min. Subsequent adjustments to IPAP are based on the results of ABGs (up to 20 cmH2O) to achieve a pH of ≥7.35 and to reduce PaCO2 to a level deemed appropriate by the attending physician.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2024-11-18
• Last updated: 2024-11-18

Locations

1 site across 1 country: China