Effects of High-intensity Noninvasive Positive Pressure Ventilation in AECOPD

Not Applicable

Completed

• Conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease
• Interventions: Device: High-intensity NPPV; Device: Low-intensity NPPV

• Registration Number: NCT04044625
• Lead Sponsor: Beijing Chao Yang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-21
• Study First Submitted QC: 2019-08-01
• Study First Posted: 2019-08-05
• Study Start: 2019-09-30
• Primary Completion: 2021-03-19
• Study Completion: 2021-06-16
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-09
• Last Update Posted: 2022-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-intensity NPPV	High-intensity NPPV	The patients will receive high-intensity noninvasive positive pressure ventilation.
Low-intensity NPPV	Low-intensity NPPV	The patients will receive low-intensity noninvasive positive pressure ventilation.

Primary Outcome Measures

Name	Time	Method
PaCO2 measured at 24 hours after enrollment	24 hours	PaCO2 measured at 24 hours after enrollment.

Secondary Outcome Measures

Name	Time	Method
PaCO2 measured at 2 hours after enrollment	2 hours	PaCO2 measured at 2 hours after enrollment
PaCO2 measured at 6 hours after enrollment	6 hours	PaCO2 measured at 6 hours after enrollment
PaCO2 measured at 48 hours after enrollment	48 hours	PaCO2 measured at 48 hours after enrollment
PaCO2 measured at 72 hours after enrollment	72 hours	PaCO2 measured at 72 hours after enrollment
Glasgow coma scale score	72 hours	The glasgow coma scale score, ranging from 3 (coma) to 15 (normal consciousness), will be used to assess the consciousness level.
ΔPes	72 hours	Inspiratory esophageal pressure swing
Dyspnea score	72 hours	The dyspnea score will be assessed using a verbal analogue scale with levels from 0 (no dyspnea) to 10 (maximum dyspnea).
NPPV tolerance score	72 hours	NPPV tolerance will be recorded on a 4-point scale and then dichotomized into acceptable (score of 2 or 3) or poor (score of 0 or 1) tolerance.
Plasma level of TNF-α	72 hours	Plasma level of TNF-α
Plasma level of I-1β	72 hours	Plasma level of IL-1β
Plasma level of IL-6	72 hours	Plasma level of IL-6
Plasma level of IL-8	72 hours	Plasma level of IL-8
Plasma level of IL-10	72 hours	Plasma level of IL-10

Trial Locations

Locations (1)

Beijing Chao-Yang Hospital; 🇨🇳 Beijing, China