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NCT Number: NCT04044625

Effects of High-intensity Noninvasive Positive Pressure Ventilation in AECOPD

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.

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Key information

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Chao-Yang Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-intensity NPPV

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

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.

Primary outcomes

  1. PaCO2 measured at 24 hours after enrollment

    Time frame: 24 hours

    PaCO2 measured at 24 hours after enrollment.

Secondary outcomes

  1. PaCO2 measured at 2 hours after enrollment

    Time frame: 2 hours

    PaCO2 measured at 2 hours after enrollment

  2. PaCO2 measured at 6 hours after enrollment

    Time frame: 6 hours

    PaCO2 measured at 6 hours after enrollment

  3. PaCO2 measured at 48 hours after enrollment

    Time frame: 48 hours

    PaCO2 measured at 48 hours after enrollment

  4. PaCO2 measured at 72 hours after enrollment

    Time frame: 72 hours

    PaCO2 measured at 72 hours after enrollment

  5. Glasgow coma scale score

    Time frame: 72 hours

    The glasgow coma scale score, ranging from 3 (coma) to 15 (normal consciousness), will be used to assess the consciousness level.

  6. ΔPes

    Time frame: 72 hours

    Inspiratory esophageal pressure swing

  7. Dyspnea score

    Time frame: 72 hours

    The dyspnea score will be assessed using a verbal analogue scale with levels from 0 (no dyspnea) to 10 (maximum dyspnea).

  8. NPPV tolerance score

    Time frame: 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.

  9. Plasma level of TNF-α

    Time frame: 72 hours

    Plasma level of TNF-α

  10. Plasma level of I-1β

    Time frame: 72 hours

    Plasma level of IL-1β

  11. Plasma level of IL-6

    Time frame: 72 hours

    Plasma level of IL-6

  12. Plasma level of IL-8

    Time frame: 72 hours

    Plasma level of IL-8

  13. Plasma level of IL-10

    Time frame: 72 hours

    Plasma level of IL-10

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 5, 2019
Registry last updated
May 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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