Comparison of HFNC With NIV in Weaning COPD

Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation Clinical Trial

Official title:

Comparison of High Flow Nasal Cannula With Noninvasive Ventilation in Facilitating Weaning Chronic Obstructive Pulmonary Disease From Invasive Ventilation: a Prospective Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03458364
• Other study ID #: HFNC-002
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: July 30, 2018

Study information

• Verified date: August 2018
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

High flow nasal cannula (HFNC) has been shown to improve oxygenation and facilitate weaning in hypoxemia patients. Some clinical studies show the benefits of using HFNC in COPD patients, including reducing dead space and work of breathing. However, no clinical study has been to investigate the value of HFNC in weaning COPD patients from invasive ventilation. Thus, we proposed a randomized controlled trial to compare the use of HFNC and noninvasive ventilation (NIV) in weaning COPD.

Description:

High flow nasal cannula (HFNC) provides high concentration oxygen in a high flow, which exceeds patient's inspiratory flow demand, to improve oxygenation. In a recent meta-analysis of seven trials with 1771 patients, HFNC was shown to improve oxygenation and avoid intubation in patients with severe hypoxemia. The high velocity of the gas can rinse the dead space of the upper airway and reduce CO2 rebreathing, reduce COPD patients' work of breathing and improve the dynamic compliance of respiratory system.

Thus, we proposed a randomized controlled trial to investigate the value of high flow nasal cannula in weaning AECOPD patients from invasive ventilation, with comparison of noninvasive ventilation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 30, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

Inclusion Criteria:

• Intubated patients with Chronic obstructive pulmonary disease exacerbation

• Meeting extubation criteria (Pulmonary infection control window)

• Age > 21years and < 90 years

Exclusion Criteria:

• Tracheotomy

• Combined with severe dysfunction of other organs, including heart, brain, liver, and renal failure;

• Hemodynamic instability

• Contraindication to NIV: cannot use mask, such as facial injury, burns or deformities; cannot cooperate with NIV such as delirium; copious secretions with weak cough ability; gastric over distention, and vomiting;

• Contraindication to HFNC: rhinitis, nasal congestion, deformities or blockage.

• Weak cough ability with copious secretions

• Refuse to participate in the study

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• High flow nasal cannula
High-flow nasal cannula (HFNC) oxygen therapy is a recent technique delivering a high flow of heated and humidified gas. HFNC is simpler to use and apply than noninvasive ventilation (NIV) and appears to be a good alternative treatment for hypoxemic acute respiratory failure (ARF). HFNC is better tolerated than NIV, delivers high fraction of inspired oxygen (FiO2), generates a low level of positive pressure and provides washout of dead space in the upper airways, thereby improving mechanical pulmonary properties and unloading inspiratory muscles during ARF.
• Noninvasive ventilation
Non-invasive ventilation (NIV) is the use of airway support administered through a face (nasal) mask instead of an endotracheal tube. Inhaled gases are given with positive end-expiratory pressure often with pressure support or with assist control ventilation at a set tidal volume and rate. Numerous studies have shown this technique to be as effective as, and better tolerated than, intubation and mechanical ventilation in patients with exacerbations of COPD

Locations

Country	Name	City	State
China	Binzhou Medical University Hospital	Yantai	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Jie Li	Binzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

Lv Y, Lv Q, Lv Q, Lai T. Pulmonary infection control window as a switching point for sequential ventilation in the treatment of COPD patients: a meta-analysis. Int J Chron Obstruct Pulmon Dis. 2017 Apr 24;12:1255-1267. doi: 10.2147/COPD.S126736. eCollection 2017. — View Citation

Mauri T, Turrini C, Eronia N, Grasselli G, Volta CA, Bellani G, Pesenti A. Physiologic Effects of High-Flow Nasal Cannula in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2017 May 1;195(9):1207-1215. doi: 10.1164/rccm.201605-0916OC. — View Citation

Rochwerg B, Brochard L, Elliott MW, Hess D, Hill NS, Nava S, Navalesi P Members Of The Steering Committee, Antonelli M, Brozek J, Conti G, Ferrer M, Guntupalli K, Jaber S, Keenan S, Mancebo J, Mehta S, Raoof S Members Of The Task Force. Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur Respir J. 2017 Aug 31;50(2). pii: 1602426. doi: 10.1183/13993003.02426-2016. Print 2017 Aug. Review. — View Citation

Zhu Y, Yin H, Zhang R, Wei J. High-flow nasal cannula oxygen therapy versus conventional oxygen therapy in patients with acute respiratory failure: a systematic review and meta-analysis of randomized controlled trials. BMC Pulm Med. 2017 Dec 13;17(1):201. doi: 10.1186/s12890-017-0525-0. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pH	pH	change from the baseline pH within 48 hours
Primary	PaCO2	PaCO2 in mmHg	change from the baseline PaCO2 within 48 hours
Primary	PaO2/FiO2	partial pressure of oxygen in arterial blood/ fraction of inspired oxygen in mmHg	change from the baseline PaO2/FiO2 within 48 hours
Primary	HR	Heart Rate in beats per minute	change from the baseline HR within 48 hours
Primary	MAP	mean arterial pressure in mmHg	change from the baseline MAP within 48 hours
Primary	RR	respiratory rate in breaths per minute	change from the baseline RR within 48 hours
Secondary	duration of respiratory support	hours of ventilator use	28 days
Secondary	Length of ICU stay	Days of stay in ICU	28 days
Secondary	Mortality		28 days
Secondary	the patients' comfort score	comfort score of using high flow nasal cannula or noninvasive ventilator, ranging from 1 to 10. 1 means very comfortable, 10 means very uncomfortable.	48 hours
Secondary	incidence of nasal trauma		28 days
Secondary	incidence of barotrauma		28 days