NCT03627598

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 13, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

1.1 years

First QC Date

August 4, 2018

Last Update Submit

August 8, 2018

Conditions

Hypercapnic Respiratory Failure

Keywords

high flow oxygennon invasive ventilationhypercapnic respiratory failure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Time to obtain NIV withdrawal criteria

    28 days

  • NIV failure

    28 days

  • ICU length of stay

    28 days

  • ICU Mortality

    28 days

Study Arms (2)

standard group

ACTIVE COMPARATOR

NIV alternating with low oxygen therapy at 1 to 4 liters per minute to obtain SpO2 between 88% and 94%.

Device: standard

HFNC group

EXPERIMENTAL

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

Interventions

HFNCDEVICE

patients will receive high flow warmed air with low inspired fraction of oxygen between non invasive ventilation sessions

HFNC group
standardDEVICE

patients will receive low flow oxygen therapy at 1 to 4 liters per minute

standard group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Unit

Mahdia, 5100, Tunisia

RECRUITING

Related Publications (2)

  • 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. No abstract available.

    PMID: 26947372BACKGROUND

  • 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 JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.

    PMID: 25981908RESULT

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Reference Standards

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Weights and MeasuresInvestigative Techniques

Central Study Contacts

Nejla Tilouche, MD

CONTACT

0021623277911tilouche.nejla@gmail.com

souheil elatrous, MD

CONTACT

0021698403053souheilatrous@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medecine doctor

Study Record Dates

First Submitted

August 4, 2018

First Posted

August 13, 2018

Study Start

July 1, 2018

Primary Completion

August 1, 2019

Study Completion

October 1, 2019

Last Updated

August 13, 2018

Record last verified: 2018-08

Locations

TU(1)