HFNC vs Nasal Cannula in Mild Chronic Obstructive Pulmonary Disease Exacerbation

NCT ID: NCT03003559

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 328 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2020-12-31

Brief Summary

For AECOPD patients, only 8% patients ventilated by noninvasive and invasive positive pressure ventilation. Nasal cannula is the most common pattern of oxygen therapy in mild AECOPD. As a low flow oxygen therapy, nasal cannula has many disadvantages.Therefore, we design a randomized controlled trial(RCT)to explore whether HFNC would be better than nasal cannula to prevent the aggravation of respiratory failure and endotracheal intubation in mild AECOPD.

Detailed Description

For AECOPD patients, most of patients don't need respiratory support, only 8% patients ventilated by noninvasive and invasive positive pressure ventilation. Nasal cannula is the most common pattern of oxygen therapy in mild AECOPD. As a low flow oxygen therapy, nasal cannula has many disadvantages: discomfort, low humidity and unstable fraction of inspired oxygen(FiO2) in inspiratory gas. Therefore, we design a RCT to explore whether HFNC would be better than nasal cannula to prevent the aggravation of respiratory failure and endotracheal intubation in mild AECOPD.

Conditions

COPD Exacerbation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High flow nasal cannula

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.

Group Type: EXPERIMENTAL

High flow nasal cannula

Intervention Type: 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.

Nasal cannula

Nasal cannula;set oxygen flow to keep SpO2 90-95%

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

High flow nasal cannula

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.

Intervention Type: DEVICE

Other Intervention Names

High flow oxygen

Eligibility Criteria

Inclusion Criteria

• AECOPD; pH≥7.35, PaCO2>45 mmHg

Exclusion Criteria

• Need to be intubated immediately; refuse to engage in the study; severe organ dysfunction

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Qingyuan Zhan

head of Pulmonary and Critical care medicine ward 4

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qingyuan Zhan, M.D.

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Locations

China-Japan Friendship hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jingen Xia, Master

Role: CONTACT

xiajingen_00632@163.com

13466396561 ext. +86

Facility Contacts

Chen Wang, MD

Role: primary

References

Xia J, Yang H, Zhan Q, Fan Y, Wang C. High-flow nasal cannula may prolong the length of hospital stay in patients with hypercapnic acute COPD exacerbation. Respir Med. 2023 Dec;220:107465. doi: 10.1016/j.rmed.2023.107465. Epub 2023 Nov 11.

Reference Type: DERIVED

PMID: 37956934 (View on PubMed)

Xia J, Gu S, Lei W, Zhang J, Wei H, Liu C, Zhang H, Lu R, Zhang L, Jiang M, Hu C, Cheng Z, Wei C, Chen Y, Lu F, Chen M, Bi H, Liu H, Yan C, Teng H, Yang Y, Liang C, Ge Y, Hou P, Liu J, Gao W, Zhang Y, Feng Y, Tao C, Huang X, Pan P, Luo H, Yun C, Zhan Q. High-flow nasal cannula versus conventional oxygen therapy in acute COPD exacerbation with mild hypercapnia: a multicenter randomized controlled trial. Crit Care. 2022 Apr 15;26(1):109. doi: 10.1186/s13054-022-03973-7.

Reference Type: DERIVED

PMID: 35428349 (View on PubMed)

Other Identifiers

2016YFC1304304-1

Identifier Type: -

Identifier Source: org_study_id