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Completed

NCT Number: NCT03458364

Comparison of HFNC With NIV in Weaning COPD

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Binzhou Medical University Hospital

Yantai, Shandong, 264003, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Flow Nasal Cannula

Device

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.

Other names: High flow high humidity nasal cannula

Noninvasive Ventilation

Device

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

Other names: Noninvasive positive pressure ventilation; Noninvasive mechanical ventilation

Primary outcomes

  1. pH

    Time frame: change from the baseline pH within 48 hours

    pH

  2. PaCO2

    Time frame: change from the baseline PaCO2 within 48 hours

    PaCO2 in mmHg

  3. PaO2/FiO2

    Time frame: change from the baseline PaO2/FiO2 within 48 hours

    partial pressure of oxygen in arterial blood/ fraction of inspired oxygen in mmHg

  4. HR

    Time frame: change from the baseline HR within 48 hours

    Heart Rate in beats per minute

  5. MAP

    Time frame: change from the baseline MAP within 48 hours

    mean arterial pressure in mmHg

  6. RR

    Time frame: change from the baseline RR within 48 hours

    respiratory rate in breaths per minute

Secondary outcomes

  1. duration of respiratory support

    Time frame: 28 days

    hours of ventilator use

  2. Length of ICU stay

    Time frame: 28 days

    Days of stay in ICU

  3. Mortality

    Time frame: 28 days

  4. the patients' comfort score

    Time frame: 48 hours

    comfort score of using high flow nasal cannula or noninvasive ventilator, ranging from 1 to 10. 1 means very comfortable, 10 means very uncomfortable.

  5. incidence of nasal trauma

    Time frame: 28 days

  6. incidence of barotrauma

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Jie Li

Other

Collaborators

  • Binzhou Medical University

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 8, 2018
Registry last updated
Aug 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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