Effects of High-intensity Noninvasive Positive Pressure Ventilation in AECOPD

NCT ID: NCT04044625

Last Updated: 2022-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-30
• Study Completion Date: 2021-06-16

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

High-intensity NPPV

The patients will receive high-intensity noninvasive positive pressure ventilation.

Group Type: EXPERIMENTAL

High-intensity NPPV

Intervention Type: DEVICE

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.

Low-intensity NPPV

The patients will receive low-intensity noninvasive positive pressure ventilation.

Group Type: ACTIVE_COMPARATOR

Low-intensity NPPV

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility 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. Arterial oxygen tension/fraction of inspired oxygen <100 mmHg

9. Pneumothorax

10. Severe ventricular arrhythmia or myocardial ischemia

11. Severe hemodynamic instability despite fluid repletion and use of vasoactive agents

12. Severe metabolic acidosis

13. Refusal to receive NPPV

14. Endotracheal intubation already performed before ICU admission

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Chao Yang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zujin Luo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zujin Luo, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Chao Yang Hospital

Locations

Beijing Chao-Yang Hospital

Beijing, , China

Countries

China

References

Luo Z, Cao Z, Li Y, Jin J, Sun W, Zhu J, Zhao N, Liu J, Wei B, Hu Y, Zhang Y, Ma Y, Wang C. Physiological effects of high-intensity versus low-intensity noninvasive positive pressure ventilation in patients with acute exacerbation of chronic obstructive pulmonary disease: a randomised controlled trial. Ann Intensive Care. 2022 May 19;12(1):41. doi: 10.1186/s13613-022-01018-4.

Reference Type: DERIVED

PMID: 35587843 (View on PubMed)

Other Identifiers

BeijingCYH-ICU-007

Identifier Type: -

Identifier Source: org_study_id