High Flow Nasal Cannula vs NPPV in Moderate Chronic Obstructive Pulmonary Disease Exacerbation

NCT03014869 | Unknown

• 1 other identifier: 2016YFC1304304-2
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 1

Brief Summary

For moderate AECOPD(pH\<7.35), several guidelines have strongly recommended NPPV as standard therapy, which can reduce the rate of intubation and mortality. A few previous studies have shown that HFNC can efficiently improve alveoli ventilation and breathing pattern in some severe AECOPD patients. Therefore, we hypothesize that HFNC is not inferior to NPPV for preventing endotracheal intubation in moderate AECOPD patients. To assess this hypothesis, we performed a multicenter, randomized, noninferiority trial of HFNV vs NPPV in moderate AECOPD patients.

Conditions

COPD Exacerbation

Keywords

COPD Exacerbation; High Flow Oxygen; Noninvasive Positive Ventilation; moderate

Outcome Measures

Primary Outcomes (1)

• endotracheal intubation demand rate

  90days

Secondary Outcomes (1)

• actual endotracheal intubation rate

  90days

Study Arms (2)

High flow nasal cannula

EXPERIMENTAL

High flow nasal cannula(OptiflowTM); Flow 25-60 L/min is set according to patients' comfort; FiO2 is adjusted to maintain peripheral capillary oxygen saturation(SpO2) 90-95%; temperature is set at 37 degree centigrade.

Device: High flow nasal cannula

Noninvasive positive ventilation

NO INTERVENTION

Parameters are set according to NPPV protocols

Interventions

High flow nasal cannula DEVICE

High flow nasal cannula (HFNC) is a new emerging noninvasive respiratory support technology, which mainly includes high flow (15-60 L/min) device, heating humidification device and nasal cannula for high flow. A large number of physiological studies confirmed that HFNC has the following critical physiological effects: promoting airway humidification, improving tolerance of treatment, reducing the physiological dead space on the upper respiratory tract, producing a certain level of positive end expiratory pressure (2-7 cmH2O), decreasing the work of breathing and so on.

Also known as: High flow oxygen

High flow nasal cannula

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AECOPD; 7.35\>pH≥7.25，PaCO2\>50 mmHg

You may not qualify if:

• contraindications for NPPV, such as thick sputum, cough weakness, hemodynamic instability, etc.; need to be intubated immediately; refuse to engage in the study; severe organ dysfunction

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship hospital

Beijing, Beijing Municipality, 100028, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Qingyuan Zhan, M.D.

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingen Xia, Master

CONTACT

13466396561; xiajingen_00632@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of Pulmonary and Critical care medicine ward 4

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 9, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)