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Trial record 12 of 46062 for:    intensity

Effects of High-intensity Noninvasive Positive Pressure Ventilation in AECOPD

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ClinicalTrials.gov Identifier: NCT04044625
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Zujin Luo, 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.

Condition or disease Intervention/treatment Phase
Acute Exacerbation of Chronic Obstructive Pulmonary Disease Device: High-intensity NPPV Device: Low-intensity NPPV Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

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.




Primary Outcome Measures :
  1. PaCO2 measured at 24 hours after enrollment [ Time Frame: 24 hours ]
    PaCO2 measured at 24 hours after enrollment.


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. pH <7.25
  9. Arterial oxygen tension/fraction of inspired oxygen <150 mmHg
  10. Pneumothorax
  11. Severe ventricular arrhythmia or myocardial ischemia
  12. Severe hemodynamic instability despite fluid repletion and use of vasoactive agents
  13. Severe metabolic acidosis
  14. Refusal to receive NPPV
  15. Endotracheal intubation already performed before ICU admission

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04044625


Contacts
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Contact: Zujin Luo, MD 81-10-13810497587 xmjg2002@163.com

Locations
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China
Beijing Chao-Yang Hospital Recruiting
Beijing, China
Contact: Zujin Luo, MD         
Sponsors and Collaborators
Beijing Chao Yang Hospital
Investigators
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Principal Investigator: Zujin Luo, MD Beijing Chao Yang Hospital

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Responsible Party: Zujin Luo, Principal Investigator, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT04044625     History of Changes
Other Study ID Numbers: BeijingCYH-ICU-007
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases