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High Flow Oxygen and Non Invasive Ventilation for Hypercapnic Respiratory Failure

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03627598
Enrollment
100
Registered
2018-08-13
Start date
2018-07-01
Completion date
2019-10-31
Last updated
2018-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercapnic Respiratory Failure

Keywords

high flow oxygen, non invasive ventilation, hypercapnic respiratory failure

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.

Interventions

DEVICEHFNC

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

DEVICEstandard

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

Sponsors

University Hospital, Mahdia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
duration of NIV28 daysnumber 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

MeasureTime frameDescription
Time to obtain NIV withdrawal criteria28 daysthe day patients do not have signs of acute respiratory failure and no respiratory acidosis (pH \<7.36)
NIV failure28 daysneed for intubation or death
ICU length of stay28 daysnumber of days spent in the ICU for this episode of exacerbation
ICU Mortality28 daysdeath in the ICU during the recorded episode

Countries

Tunisia

Contacts

Primary ContactNejla Tilouche, MD
tilouche.nejla@gmail.com0021623277911
Backup Contactsouheil elatrous, MD
souheilatrous@gmail.com0021698403053

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026