The physiologic study of high-flow nasal oxygen cannula in patients with chronic obstructive pulmonary disease with acute exacerbation requiring ventilator support
Study ID: TCTR20160902001
Current status: Completed
Last Updated: November 06, 2017
Tracking Information
Date of Registration in Primary Registry: August 31, 2016
Date of First Enrollment: September 01, 2016 (Anticipated)
Target Sample Size: 12
Last Updated Date: November 06, 2017
Primary Outcome(s):
  • Outcome name: Patient's work of breathing
       Metric/method of measurement: Esophageal pressure-time product
       Time point: every 15 minutes
       Safety Issue?: No


  • Key Secondary Outcomes:
  • Outcome name: Respiratory variables
       Metric/method of measurement: Respiratory rate, oxygen saturation, transcutaneous CO2 monitoring
       Time point: every 15 minutes
       Safety Issue?: No


  • Outcome name: Hemodynamic variables
       Metric/method of measurement: Blood pressure, heart rate
       Time point: every 15 minutes
       Safety Issue?: No


  • Outcome name: Dyspnea
       Metric/method of measurement: Dyspnea visual analog scale
       Time point: every 15 minutes
       Safety Issue?: No


  • Descriptive Information
    Public Title: The physiologic study of high-flow nasal oxygen cannula in patients with chronic obstructive pulmonary disease with acute exacerbation requiring ventilator support
    Scientific Title: The physiologic study of high-flow nasal oxygen cannula in patients with chronic obstructive pulmonary disease with acute exacerbation requiring ventilator support
    Brief Summary: Acute hypercapneic respiratory failure frequently occur during acute exacerbation of chronic obstructive pulmonary disease (COPD). Non-invasive ventilation (NIV) is a first-line treatment of such condition. Many studies have been shown that NIV reduced work of breathing, dyspnea, endotracheal intubation and mortality. High-flow nasal oxygen cannula (HFNC) is a relatively new device which provides high flow rate of gas (up to 60 LPM)and constant FiO2 (21-100%). Current evidences demonstrate the benefits of HFNC in patients with acute hypoxemic respiratory failure and after extubation. Regarding the mechanisms of HFNC should also have potential benefits in COPD patients with acute exacerbation who require ventilator support. This physiologic study will focus on the effect of HFNC on patient's work of breathing in COPD patients requiring ventilator support.
    Detailed Description:
    Study Design: Allocation: N/A
    Control: N/A
    Study Endpoint Classification: Safety/Efficacy Study
    Intervention Model: Single Group
    Number of Arms: 1
    Masking: N/A (Masked Roles: )
    Primary Purpose: Treatment
    Study Phase: N/A
    Health Condition(s) or Problem(s) Studied: Patients with chronic ostructive pulmonary disease presented with acute exacerbation and requiring non-invasive ventilation
    Study Arms:
  • Arm: 1
  • Intervention Name: High-flow nasal oxygen cannula
    Type: Experimental
    Classification: Device
    Descriptions: Subjects will receive HFNC starting from flow rate at 10 LPM and gradually increase to 20, 30, 40, 50 and 60 LPM. Each step will take 15 minutes.
    Recruitment Information
    Recruitment Status: Completed
    Estimated Enrollment: 12
    Study Start Date (First enrollment): September 01, 2016
    Primary Completion Date: February 28, 2017
    Inclusion Criteria:
    Inclusion Criteria
    Gender: Both
    Age Limit: Minimum 40 Years : Maximum 85 Years
    1 Age 40 85 years old
    2 Patients who was diagnosed COPD classified by GOLD criteria post bronchodilator FEV1 FVC 70
    3 Acute exacerbation of COPD with indication for NIV use as follows
    Acute respiratory acidosis pH 45 mmHg
    Respiratory rate 24 breaths min
    Accessory muscles use or abdominal paradox breathing
    Exclusion Criteria
    1 pH 7 25
    2 Severe hypoxemia
    3 Alteration of consciousness and uncooperative GCS 8
    4 Hemodynamic instability or serious cardiac problem e g hypotension malignant arrhythmia myocardial ischemia
    5 Facial abnormality or recent facial upper GI tract surgery
    6 Uncontrolled airway or upper GI bleeding
    7 Contraindication for insertion of esophageal balloon catheter ulcer varices tumor recent esophageal gastric surgery bleeding diathesis or allergy to lidocaine
    Accept Healthy Volunteers: No
    Countries of Recruitment Thailand
    Contact for Public Queries:
    Contact for Public Query's Name: Nuttpol Rittayamai
    Phone: +6624197757        Ext: 11
    Email: nuttapol.rit@mahidol.ac.thy
    Postal Address: 2 Prannok Raod
    State/Province: Bangkok        Postal Code: 10700
    Country: Thailand
    Contact for Public Query's Name: Nuttpol Rittayamai
    Phone: +6624197757        Ext: 11
    Email: nuttapol.rit@mahidol.ac.thy
    Postal Address: 2 Prannok Road
    State/Province: Bangkok        Postal Code: 10700
    Country: Thailand
    Administrative Information
    Primary Registry Site: Thai Clinical Trials Registry
    Trial Identification Number: TCTR20160902001
    Secondary Identifying Numbers: Nil known
    Source(s) of Monetary or Material Supports: Faculty of Medicine Siriraj Hospital
    Study Primary Sponsor: Faculty of Medicine Siriraj Hospital
    Study Secondary Sponsor: 1.) N/A
    Contact for Scientific Queries:
    Contact for Scientific Query's Name: Nuttpol Rittayamai
    Phone: +6624197757        Ext: 11
    Email: nuttapol.rit@mahidol.ac.thy
    Postal Address: 2 Prannok Raod
    State/Province: Bangkok        Postal Code: 10700
    Country: Thailand
    Track changes

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