NCT03238014

Brief Summary

High-intensity noninvasive positive pressure ventilation (NPPV), which can well improve the gas exchange and reduce the work of breathing of patients, is a new strategy targeted at maximally reducing arterial carbon dioxide. However, no definitive conclusions have been drawn to decide whether high-intensity NPPV is the best setting for treating patients with chronic hypercapnic COPD. For now, no unified method for setting up high-pressure NPPV has been established. Most of the trials utilized gradually increased inspiratory positive airway pressure depending on the patient's tolerance. However, from a respiratory physiology point of view, excessive inspiratory positive airway pressure may lead to lung hyperinflation, increased intrinsic positive end expiratory pressures, increased oxygen consumption, and ineffective work of breathing.Therefore, seeking a method to establish individualized high-intensity NPPV is of vital importance.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

July 27, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

2.8 years

First QC Date

July 27, 2017

Last Update Submit

February 4, 2020

Conditions

COPDHypercapnic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • Partial pressure of arterial blood carbon dioxide (PaCO2)

    Daytime arterial blood gas samples were taken with patients resting in a sitting position and breathing room air without having used NPPV for at least 1 hour.

    12 weeks

Secondary Outcomes (6)

  • Severe Respiratory Insufficiency (SRI) Questionnaire

    12 weeks

  • Baseline Dyspnea Index/Transition Dyspnea Index

    12 weeks

  • Chromic Respiratory Questionnaire

    12 weeks

  • COPD assessment test

    12 weeks

  • Pulmonary function

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

High-intensity noninvasive ventilation

EXPERIMENTAL

High-intensity noninvasive positive pressure ventilation aims at maximally improving PaCO2.

Device: Noninvasive positive pressure ventilation

Low-intensity noninvasive ventilation

ACTIVE COMPARATOR

Low-intensity noninvasive positive pressure ventilation is a classic setting of noninvasive ventilation.

Device: Noninvasive positive pressure ventilation

Interventions

Noninvasive positive pressure ventilationDEVICE

Noninvasive positive pressure ventilation used assist/control mode treat severe stable chronic obstructive pulmonary disease.

Also known as: Noninvasive ventilation
High-intensity noninvasive ventilationLow-intensity noninvasive ventilation

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically stable with chronic hypercapnic COPD (baseline arterial carbon dioxide pressure (PaCO2) of 50 mmHg or higher, measured resting in a sitting position and breathing room air without having used NPPV for at least 1 hour)

You may not qualify if:

  • other lung/pleural diseases or thoracic deformity
  • severe heart failure (New York Heart Association class IV), severe dysrhythmia
  • unstable angina, or malignant comorbidity
  • obesity (BMI ≥ 35 kg/m²)
  • severe obstructive sleep apnea syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Institute of Respiratory Disease

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveRespiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration Disorders

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Rongchang Chen

    Guangzhou Institute of Respiratory Disease

    STUDY DIRECTOR

Central Study Contacts

Lili Guan

CONTACT

+8613422288665dr_nickguan@163.com

Luqian Zhou

CONTACT

+8613826098411icelucy@126.com

Study Design

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

Study Record Dates

First Submitted

July 27, 2017

First Posted

August 3, 2017

Study Start

August 1, 2017

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

February 5, 2020

Record last verified: 2020-02

Locations

CN(1)