High Flow Oxygen and Non Invasive Ventilation for Hypercapnic Respiratory Failure

Hypercapnic Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03627598
• Other study ID #: 140284
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: October 2019

Study information

• Verified date: August 2018
• Source: University Hospital, Mahdia
• Contact: Nejla Tilouche, MD
• Phone: 0021623277911
• Email: tilouche.nejla[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypercapnia
• Hypercapnic Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• HFNC
patients will receive high flow warmed air with low inspired fraction of oxygen between non invasive ventilation sessions
• standard
patients will receive low flow oxygen therapy at 1 to 4 liters per minute

Locations

Country	Name	City	State
Tunisia	Intensive Care Unit	Mahdia

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Mahdia

Country where clinical trial is conducted

Tunisia, 

References & Publications (2)

Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier J — View Citation

Lepere V, Messika J, La Combe B, Ricard JD. High-flow nasal cannula oxygen supply as treatment in hypercapnic respiratory failure. Am J Emerg Med. 2016 Sep;34(9):1914.e1-2. doi: 10.1016/j.ajem.2016.02.020. Epub 2016 Feb 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of NIV	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	28 days
Secondary	Time to obtain NIV withdrawal criteria	the day patients do not have signs of acute respiratory failure and no respiratory acidosis (pH <7.36)	28 days
Secondary	NIV failure	need for intubation or death	28 days
Secondary	ICU length of stay	number of days spent in the ICU for this episode of exacerbation	28 days
Secondary	ICU Mortality	death in the ICU during the recorded episode	28 days