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High Flow Oxygen and Non Invasive Ventilation for Hypercapnic Respiratory Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03627598
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Nejla Tilouche, University Hospital, Mahdia

Brief Summary:
this study evaluates high flow oxygen therapy in addition to non invasive ventilation (NIV) to treat hypercapnic respiratory failure. Between sessions of NIV, half of participants will have high flow nasal cannula while the others will have standard low flow oxygen therapy.

Condition or disease Intervention/treatment Phase
Hypercapnic Respiratory Failure Device: HFNC Device: standard Not Applicable

Detailed Description:

High Flow Nasal Cannula (HFNC) is a new way of oxygen therapy that has gained interest in the management of patients with acute respiratory failure. It allows reaching a high flow air up to 60 liters / min via a nasal cannula with a humidification and warming of the air administered. It has a number of physiological effects such as wash out of anatomical dead space, generation of a small PEEP and high inspired fraction of oxygen which enhances compliance and reduces inspiratory efforts.

NIV is the corner stone in the treatment of severe COPD exacerbation. Nevertheless, prolonged application of the facial mask expose to local complications and intolerance which can be a cause of failure, so reducing the duration of exposure to this procedure is important.

The role of HFNC in supplementing NIV effect during hypercapnic respiratory failure has not been assessed. Much of the data available on HFNC are about hypoxemic respiratory failure.

Because of its physiological effects, it can be hypothesized that HFNC in addition to NIV can shorten its duration by facilitating carbon dioxide clearance.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Flow Nasal Oxygen in Addition to Non Invasive Ventilation During Hypercapnic Respiratory Failure
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: standard group
NIV alternating with low oxygen therapy at 1 to 4 liters per minute to obtain SpO2 between 88% and 94%.
Device: standard
patients will receive low flow oxygen therapy at 1 to 4 liters per minute

Experimental: HFNC group
NIV alternating with HFNC delivering the equivalent inspired fraction of oxygen (FiO2) with a flow at 30 to 60 liters/min through an Optiflow nasal interface.
Device: HFNC
patients will receive high flow warmed air with low inspired fraction of oxygen between non invasive ventilation sessions




Primary Outcome Measures :
  1. duration of NIV [ Time Frame: 28 days ]
    number of days patients received NIV, and for patients with home NIV: it is the number of days spent to achieve the usual daily NIV hours with clinical and gasometric stability


Secondary Outcome Measures :
  1. Time to obtain NIV withdrawal criteria [ Time Frame: 28 days ]
    the day patients do not have signs of acute respiratory failure and no respiratory acidosis (pH <7.36)

  2. NIV failure [ Time Frame: 28 days ]
    need for intubation or death

  3. ICU length of stay [ Time Frame: 28 days ]
    number of days spent in the ICU for this episode of exacerbation

  4. ICU Mortality [ Time Frame: 28 days ]
    death in the ICU during the recorded episode



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged more than 18 years with a diagnosis of acute-on-chronic respiratory failure and respiratory acidosis requiring NIV.

Exclusion Criteria:

  • Patient included in another study
  • Patients intubated at ICU admission or within 12 hours
  • Contraindication to NIV including: pneumothorax, Hemodynamic instability, GCS less than 12, facial malformation
  • Asthma
  • A do not intubate order
  • Neuromuscular disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627598


Contacts
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Contact: Nejla Tilouche, MD 0021623277911 tilouche.nejla@gmail.com
Contact: souheil elatrous, MD 0021698403053 souheilatrous@gmail.com

Locations
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Tunisia
Intensive Care Unit Recruiting
Mahdia, Tunisia, 5100
Contact: Nejla Tilouche, MD    0021623277911    tilouche.nejla@gmail.com   
Contact: souheil Elatrous, MD    0021698403053    souheilatrous@gmail.com   
Sponsors and Collaborators
University Hospital, Mahdia
Publications of Results:
Other Publications:
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Responsible Party: Nejla Tilouche, medecine doctor, University Hospital, Mahdia
ClinicalTrials.gov Identifier: NCT03627598    
Other Study ID Numbers: 140284
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nejla Tilouche, University Hospital, Mahdia:
high flow oxygen
non invasive ventilation
hypercapnic respiratory failure
Additional relevant MeSH terms:
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Respiratory Insufficiency
Hypercapnia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms