Effects of High-intensity Noninvasive Positive Pressure Ventilation in AECOPD

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: High-intensity NPPV; Device: Low-intensity NPPV

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Chao-Yang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: High-intensity NPPV; The patients will receive high-intensity noninvasive positive pressure ventilation.	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.
ACTIVE_COMPARATOR: Low-intensity NPPV; The patients will receive low-intensity noninvasive positive pressure ventilation.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PaCO2 measured at 24 hours after enrollment	PaCO2 measured at 24 hours after enrollment.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PaCO2 measured at 2 hours after enrollment	PaCO2 measured at 2 hours after enrollment	2 hours
PaCO2 measured at 6 hours after enrollment	PaCO2 measured at 6 hours after enrollment	6 hours
PaCO2 measured at 48 hours after enrollment	PaCO2 measured at 48 hours after enrollment	48 hours
PaCO2 measured at 72 hours after enrollment	PaCO2 measured at 72 hours after enrollment	72 hours
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
ΔPes	Inspiratory esophageal pressure swing	72 hours
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
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
Plasma level of TNF-α	Plasma level of TNF-α	72 hours
Plasma level of I-1β	Plasma level of IL-1β	72 hours
Plasma level of IL-6	Plasma level of IL-6	72 hours
Plasma level of IL-8	Plasma level of IL-8	72 hours
Plasma level of IL-10	Plasma level of IL-10	72 hours

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 30, 2019
• Primary Completion (ACTUAL): March 19, 2021
• Study Completion (ACTUAL): June 16, 2021

Study Registration Dates

• First Submitted: May 21, 2019
• First Submitted That Met QC Criteria: August 1, 2019
• First Posted (ACTUAL): August 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: BeijingCYH-ICU-007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No