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Clinical Trials/NCT03627598
NCT03627598
Unknown
Not Applicable

High Flow Nasal Oxygen in Addition to Non Invasive Ventilation During Hypercapnic Respiratory Failure

University Hospital, Mahdia1 site in 1 country100 target enrollmentJuly 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypercapnic Respiratory Failure
Sponsor
University Hospital, Mahdia
Enrollment
100
Locations
1
Primary Endpoint
duration of NIV
Last Updated
7 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2018
End Date
October 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Mahdia
Responsible Party
Principal Investigator
Principal Investigator

Nejla Tilouche

medecine doctor

University Hospital, Mahdia

Eligibility 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
  • A do not intubate order
  • Neuromuscular disease

Outcomes

Primary Outcomes

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 Outcomes

  • ICU length of stay(28 days)
  • ICU Mortality(28 days)
  • NIV failure(28 days)
  • Time to obtain NIV withdrawal criteria(28 days)

Study Sites (1)

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