Effects of High-intensity Noninvasive Positive Pressure Ventilation in AECOPD

Acute Exacerbation of Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04044625
• Other study ID #: BeijingCYH-ICU-007
• Status: Completed
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: June 16, 2021

Study information

• Verified date: May 2022
• Source: Beijing Chao Yang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 16, 2021
• Est. primary completion date: March 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Exacerbation of Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing Chao-Yang Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PaCO2 measured at 24 hours after enrollment	PaCO2 measured at 24 hours after enrollment.	24 hours
Secondary	PaCO2 measured at 2 hours after enrollment	PaCO2 measured at 2 hours after enrollment	2 hours
Secondary	PaCO2 measured at 6 hours after enrollment	PaCO2 measured at 6 hours after enrollment	6 hours
Secondary	PaCO2 measured at 48 hours after enrollment	PaCO2 measured at 48 hours after enrollment	48 hours
Secondary	PaCO2 measured at 72 hours after enrollment	PaCO2 measured at 72 hours after enrollment	72 hours
Secondary	Glasgow coma scale score	The glasgow coma scale score, ranging from 3 (coma) to 15 (normal consciousness), will be used to assess the consciousness level.	72 hours
Secondary	?Pes	Inspiratory esophageal pressure swing	72 hours
Secondary	Dyspnea score	The dyspnea score will be assessed using a verbal analogue scale with levels from 0 (no dyspnea) to 10 (maximum dyspnea).	72 hours
Secondary	NPPV tolerance score	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.	72 hours
Secondary	Plasma level of TNF-a	Plasma level of TNF-a	72 hours
Secondary	Plasma level of I-1ß	Plasma level of IL-1ß	72 hours
Secondary	Plasma level of IL-6	Plasma level of IL-6	72 hours
Secondary	Plasma level of IL-8	Plasma level of IL-8	72 hours
Secondary	Plasma level of IL-10	Plasma level of IL-10	72 hours