Ignite Creation Date:
2024-05-06 @ 9:38 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03033251
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2017-01-19
Brief Title:
High Flow Nasal Cannula Versus Non-Invasive Ventilation in Exacerbations of Chronic Obstructive Pulmonary Disease
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
High Flow Nasal Cannula Versus Non-Invasive Ventilation in Exacerbations of Chronic Obstructive Pulmonary Disease and Hypercapnic Respiratory Failure
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HiFOLD
Brief Summary:
Chronic obstructive lung disease is a disabling disease that affects people usually after several years of smoke tobacco exposure and affects millions of patients worldwide The disease is marked by multiples episode of worsening termed exacerbations necessitating frequent hospitalizations During these exacerbations patients present breathless and in the most severe cases are admitted to an Intensive Care Unit ICU for respiratory assistance Currently respiratory assistance is provided by a ventilator via a oronasal mask referred to non-invasive ventilation NIV that helps patients to cope with their breathless The mask is not always well tolerated and the ventilator sessions are delivered intermittently In the past decade a new technique that provides air-oxygen with high flow has been developed This technique called High Flow via Nasal Cannula HFNC can deliver from 21 to 100 heated and humidified air-oxygen at a high flow of gas via simple nasal cannula Recent studies have shown that the technique is very efficient to treat patients presenting with acute respiratory failure who dont have any underlying chronic pulmonary disease Whether the technique would be also efficient in patients with COLD presenting with severe exacerbations has not yet been demonstrated Since HFNC does not require any mask it is thought that the comfort of the patient would be much better in comparison to NIV and could potentially help to treat many patients with the disease The objective of the present study is to study the physiological effect of HFNC as compared to NIV in patients with severe exacerbations of COPD and to show that it is non-inferior to NIV
Detailed Description:
Design Prospective observational cross-over clinical physiologic study of HFNC and NIV in patients with COPD and hypercapnic respiratory failure Intervention Participants will be consecutively ventilated with the two devices ie HFNC and NIV HFNC 30 and 50 Lmin will be applied in a random order sealed opaque envelope HFNC will be set with a temperature at 37C or 34C if perceived as too warm NIV settings will be adjusted based on the clinical assessment of the Respiratory Therapist as per standard practice and will not be modified during the test In both groups FiO2 will be adjusted to achieve a SpO2 of at least 92
Setting The intervention will be applied in the Medical-Surgical ICU of St Michaels Hospital
Duration Each device will be studied for up to 30 minutes The entire study will take place over up to 3 hours There is no additional follow-up thereafter
Procedures The study will start first by recording patients under spontaneous breathing considered as a baseline sequence 1 Under spontaneous breathing patients will be receiving oxygen therapy as it is usually done between 2 NIV sessions Then the patient will have up to 30 minutes to acclimatize to HFNC and select hisher preferred flow rate sequence 2 NIV will be applied sequence 3 The NIV settings will be adjusted based on the clinical assessment of the Respiratory Therapist and will not be modified throughout the study Then according to randomization order sealed envelopes patients will receive a flow corresponding to the preferred flow selected by the patient and a second flow either HFNC 30 Lmin or HFNC 50 Lmin depending on the initial choice sequences 4 and 5 see flow diagram FiO2 will be adjusted to achieve a SpO2 of 90 to 94 Each condition will be studied fup to 30 minutes and will be separated by a 5-minute washout period during which patients will be receiving oxygen therapy The measurements will be collected at baseline under spontaneous breathing and during the last five minutes of each condition In case of clinical intolerance as considered by the attending physician the study will stop In case the patient is considered dependent of NIV by clinicians we will still enroll the patient without doing baseline period after discussion with clinicians
The pulse oximeter SpO2 and transcutaneous CO2 monitor SenTec Digital Monitoring System SDMS will be continuously monitored throughout the study period Exspiron or Electrical Impedance Tomography EIT device will be calibrated to measure minute ventilation Four surface electrodes will be placed bilaterally to record each hemidiaphragm activity using a specific recording system Acqknowledge software Biopac Systems A bedside ultrasound examination will be performed using a SonoSite system Fujifilm equipped with a 10-15 MHz ultrasound linear probe Diaphragm thickness will be measured both at end-inspiration and end-expiration This technique will be applied at the end of each sequence before ventilatory assist under conventional O2 therapy In patients becoming rapidly intolerant to NIV disconnection we will limit this baseline period under O2 to a minimum 5 minutes The thickness and contraction of the intercostal muscles and abdominal muscles will also be assessed
Interpretation of the ultrasound results to determine diaphragm and other muscle thickness will be read at a later time by an individual blinded to the intervention
Setting The intervention will be applied in the Medical-Surgical ICU of St Michaels Hospital
Duration Each device will be studied for up to 30 minutes The entire study will take place over up to 3 hours There is no additional follow-up thereafter
Procedures The study will start first by recording patients under spontaneous breathing considered as a baseline sequence 1 Under spontaneous breathing patients will be receiving oxygen therapy as it is usually done between 2 NIV sessions Then the patient will have up to 30 minutes to acclimatize to HFNC and select hisher preferred flow rate sequence 2 NIV will be applied sequence 3 The NIV settings will be adjusted based on the clinical assessment of the Respiratory Therapist and will not be modified throughout the study Then according to randomization order sealed envelopes patients will receive a flow corresponding to the preferred flow selected by the patient and a second flow either HFNC 30 Lmin or HFNC 50 Lmin depending on the initial choice sequences 4 and 5 see flow diagram FiO2 will be adjusted to achieve a SpO2 of 90 to 94 Each condition will be studied fup to 30 minutes and will be separated by a 5-minute washout period during which patients will be receiving oxygen therapy The measurements will be collected at baseline under spontaneous breathing and during the last five minutes of each condition In case of clinical intolerance as considered by the attending physician the study will stop In case the patient is considered dependent of NIV by clinicians we will still enroll the patient without doing baseline period after discussion with clinicians
The pulse oximeter SpO2 and transcutaneous CO2 monitor SenTec Digital Monitoring System SDMS will be continuously monitored throughout the study period Exspiron or Electrical Impedance Tomography EIT device will be calibrated to measure minute ventilation Four surface electrodes will be placed bilaterally to record each hemidiaphragm activity using a specific recording system Acqknowledge software Biopac Systems A bedside ultrasound examination will be performed using a SonoSite system Fujifilm equipped with a 10-15 MHz ultrasound linear probe Diaphragm thickness will be measured both at end-inspiration and end-expiration This technique will be applied at the end of each sequence before ventilatory assist under conventional O2 therapy In patients becoming rapidly intolerant to NIV disconnection we will limit this baseline period under O2 to a minimum 5 minutes The thickness and contraction of the intercostal muscles and abdominal muscles will also be assessed
Interpretation of the ultrasound results to determine diaphragm and other muscle thickness will be read at a later time by an individual blinded to the intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None