NCT04044625

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 30, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2021

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

1.5 years

First QC Date

May 21, 2019

Last Update Submit

May 9, 2022

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • PaCO2 measured at 24 hours after enrollment

    PaCO2 measured at 24 hours after enrollment.

    24 hours

Secondary Outcomes (13)

  • PaCO2 measured at 2 hours after enrollment

    2 hours

  • PaCO2 measured at 6 hours after enrollment

    6 hours

  • PaCO2 measured at 48 hours after enrollment

    48 hours

  • PaCO2 measured at 72 hours after enrollment

    72 hours

  • Glasgow coma scale score

    72 hours

  • +8 more secondary outcomes

Study Arms (2)

High-intensity NPPV

EXPERIMENTAL

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

Device: High-intensity NPPV

Low-intensity NPPV

ACTIVE COMPARATOR

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

Device: Low-intensity NPPV

Interventions

High-intensity NPPVDEVICE

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.

High-intensity NPPV
Low-intensity NPPVDEVICE

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.

Low-intensity NPPV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Chao-Yang Hospital

Beijing, China

Location

Related Publications (1)

  • 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.

    PMID: 35587843DERIVED

Study Officials

  • Zujin Luo, MD

    Beijing Chao Yang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 21, 2019

First Posted

August 5, 2019

Study Start

September 30, 2019

Primary Completion

March 19, 2021

Study Completion

June 16, 2021

Last Updated

May 10, 2022

Record last verified: 2022-05

Locations

CN(1)