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Effects of High-intensity Noninvasive Positive Pressure Ventilation in AECOPD

Primary Purpose

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
High-intensity NPPV
Low-intensity NPPV
Sponsored by
Beijing Chao Yang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Chao-Yang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-intensity NPPV

Low-intensity NPPV

Arm Description

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

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

Outcomes

Primary Outcome Measures

PaCO2 measured at 24 hours after enrollment
PaCO2 measured at 24 hours after enrollment.

Secondary Outcome Measures

PaCO2 measured at 2 hours after enrollment
PaCO2 measured at 2 hours after enrollment
PaCO2 measured at 6 hours after enrollment
PaCO2 measured at 6 hours after enrollment
PaCO2 measured at 48 hours after enrollment
PaCO2 measured at 48 hours after enrollment
PaCO2 measured at 72 hours after enrollment
PaCO2 measured at 72 hours after enrollment
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.
ΔPes
Inspiratory esophageal pressure swing
Dyspnea score
The dyspnea score will be assessed using a verbal analogue scale with levels from 0 (no dyspnea) to 10 (maximum dyspnea).
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.
Plasma level of TNF-α
Plasma level of TNF-α
Plasma level of I-1β
Plasma level of IL-1β
Plasma level of IL-6
Plasma level of IL-6
Plasma level of IL-8
Plasma level of IL-8
Plasma level of IL-10
Plasma level of IL-10

Full Information

First Posted
May 21, 2019
Last Updated
May 9, 2022
Sponsor
Beijing Chao Yang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04044625
Brief Title
Effects of High-intensity Noninvasive Positive Pressure Ventilation in AECOPD
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
March 19, 2021 (Actual)
Study Completion Date
June 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Exacerbation of Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-intensity NPPV
Arm Type
Experimental
Arm Description
The patients will receive high-intensity noninvasive positive pressure ventilation.
Arm Title
Low-intensity NPPV
Arm Type
Active Comparator
Arm Description
The patients will receive low-intensity noninvasive positive pressure ventilation.
Intervention Type
Device
Intervention Name(s)
High-intensity NPPV
Intervention Description
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
Intervention Name(s)
Low-intensity NPPV
Intervention Description
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.
Primary Outcome Measure Information:
Title
PaCO2 measured at 24 hours after enrollment
Description
PaCO2 measured at 24 hours after enrollment.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
PaCO2 measured at 2 hours after enrollment
Description
PaCO2 measured at 2 hours after enrollment
Time Frame
2 hours
Title
PaCO2 measured at 6 hours after enrollment
Description
PaCO2 measured at 6 hours after enrollment
Time Frame
6 hours
Title
PaCO2 measured at 48 hours after enrollment
Description
PaCO2 measured at 48 hours after enrollment
Time Frame
48 hours
Title
PaCO2 measured at 72 hours after enrollment
Description
PaCO2 measured at 72 hours after enrollment
Time Frame
72 hours
Title
Glasgow coma scale score
Description
The glasgow coma scale score, ranging from 3 (coma) to 15 (normal consciousness), will be used to assess the consciousness level.
Time Frame
72 hours
Title
ΔPes
Description
Inspiratory esophageal pressure swing
Time Frame
72 hours
Title
Dyspnea score
Description
The dyspnea score will be assessed using a verbal analogue scale with levels from 0 (no dyspnea) to 10 (maximum dyspnea).
Time Frame
72 hours
Title
NPPV tolerance score
Description
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.
Time Frame
72 hours
Title
Plasma level of TNF-α
Description
Plasma level of TNF-α
Time Frame
72 hours
Title
Plasma level of I-1β
Description
Plasma level of IL-1β
Time Frame
72 hours
Title
Plasma level of IL-6
Description
Plasma level of IL-6
Time Frame
72 hours
Title
Plasma level of IL-8
Description
Plasma level of IL-8
Time Frame
72 hours
Title
Plasma level of IL-10
Description
Plasma level of IL-10
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of COPD according to the criteria of the Global Initiative for Chronic Obstructive Lung Disease in 2019 Presence of acute exacerbation Arterial pH <7.35 with arterial carbon dioxide tension (PaCO2) >45 mmHg on room air or supplemental oxygen PaCO2 >45 mmHg following low-intensity NPPV of ≥6 hours Exclusion Criteria: Age <18 years Excessive amount of respiratory secretions or weak cough Upper airway obstruction Recent oral, facial, or cranial trauma or surgery; recent gastric or esophageal surgery 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) Active upper gastrointestinal bleeding Cardiac or respiratory arrest Arterial oxygen tension/fraction of inspired oxygen <100 mmHg Pneumothorax Severe ventricular arrhythmia or myocardial ischemia Severe hemodynamic instability despite fluid repletion and use of vasoactive agents Severe metabolic acidosis Refusal to receive NPPV Endotracheal intubation already performed before ICU admission
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zujin Luo, MD
Organizational Affiliation
Beijing Chao Yang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Chao-Yang Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
35587843
Citation
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.
Results Reference
derived

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Effects of High-intensity Noninvasive Positive Pressure Ventilation in AECOPD

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