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

Capital Medical University

Status: Not yet enrolling

Conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Treatments: Device: Low-intensity NPPV; Device: High-intensity NPPV

Study type: Interventional

Funder types: Other

Identifiers

NCT06692023

BeijingCYH-ICU-008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• AECOPD confirmed by the 2019 criteria of the Global Initiative for Chronic Obstructive Lung Disease (GOLD);
• Arterial pH <7.35 and PaCO2 >45 mmHg at screening entry;
• PaCO2 >45 mmHg after a 6-hour trial of low-intensity NPPV.

Exclusion criteria

• Age <18 years
• Excessive respiratory secretions with weak cough
• Upper airway obstruction
• Recent oral, facial, or cranial trauma or surgery
• Recent gastric or esophageal surgery
• Presence of 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, or severe abdominal distension)
• Active upper gastrointestinal bleeding
• Cardiac or respiratory arrest
• Arterial oxygen tension/fraction of inspired oxygen (PaO2/FiO2) <100 mmHg
• Pneumothorax
• Obvious emphysematous bullae confirmed by chest CT scan
• Ventricular arrhythmia or myocardial ischemia
• Severe hemodynamic instability (mean arterial pressure <65 mmHg)
• Severe metabolic acidosis (pH <7.20 and bicarbonate <22 mmol/L)
• Refusal to receive NPPV or give informed consent
• Prior endotracheal intubation or tracheostomy during the current hospitalization
• A do-not-intubate order

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

High-intensity NPPV

Experimental group

Description:

Patients will receive high-intensity NPPV

Treatment:

Device: High-intensity NPPV

Device: Low-intensity NPPV

Low-intensity NPPV

Active Comparator group

Description:

Patients will receive low-intensity NPPV

Treatment:

Device: High-intensity NPPV

Device: Low-intensity NPPV