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Effects of Treatment With High Flow Nasal Cannulas on Respiratory Pattern and Work of Breathing Among Patients.

Effects of Treatment With High Flow Nasal Cannulas on Respiratory Pattern and Work of Breathing Among Patients.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02494154
Acronym
HDWOBPT
Enrollment
16
Registered
2015-07-10
Start date
2015-05-31
Completion date
Unknown
Last updated
2015-07-10

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

Conditions

Respiratory Failure

Brief summary

This study evaluates the work of breathing among patients under various conditions of treatment with high flow nasal cannulas. Sixteen spontaneously breathing patients with respiratory failure (hypercapnic or hypoxemic) will be included. The design of this study is a cross over of four treatment periods with different flow settings.

Detailed description

High flow oxygen therapy (HFOT) is a promising technique increasingly used in the management of acute respiratory failure. In hospitalised hypoxemic patients, recent clinical evidence showed that HFOT can reduce endotracheal intubation and reduce mortality. Physiologically, the HFOT causes a decrease in respiratory rate and minute-ventilation and may be associated with a decrease in PaCO2. It is possible that these effects are associated with decreased work of breathing, which could explain some of the benefits in terms of comfort and efficiency. The objective of this research is to evaluate the impact of a wash-out of anatomical dead space by high flow nasal cannulas on respiratory parameters and on the work of breathing. The investigators will evaluate the baseline status with conventional oxygen therapy methods (low flows), and then compare it with three different levels of high flow oxygen therapy in a randomised order. The primary endpoint will be the work of breathing.

Interventions

DEVICEAirvo 2; Ficher and Paykel HealthCare

High flow nasal cannulas

DEVICEOxygen delivery via conventional nasal mask

Low flow of oxygen delivered through conventional nasal prongs

Sponsors

Laval University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

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

Inclusion criteria

Spontaneously breathing patients exhibiting a respiratory distress defined by a respiratory rate ≥ 20 breaths/min associated with * either hypoxemia (SpO2\<90% with O2≥3L/min) ; * or hypercapnia (PaCO2\>45 mmHg with a respiratory acidosis (pH\<7,38).

Exclusion criteria

* Patients below 18yo, pregnant or breastfeeding women; * Patients enrolled in another study excluding co-enrolment; * History of ear nose and throat disease (i.e. surgery, epistaxis, trauma), eso-gastric disease (i.e. esophageal varices, digestive haemorrhage), rheumatologic or neurologic disease possibly interfering with the design of the study; * Acute respiratory or cardiovascular disease contra-indicating the enrolment in the study protocol (i.e. acute coronary syndrome, pulmonary embolism, pneumothorax); * Need for immediate intubation or for continuous noninvasive ventilation and/or recent (\<6h) arterial blood gases showing a respiratory acidosis with a pH\<7.30; * Patient feeling nauseous or under recent fed condition (\<1h).

Design outcomes

Primary

MeasureTime frameDescription
Work of breathing15 minutesWork of breathing at the end of each period is calculated from the measurement of esophageal pressure and tidal volume (composite outcome)

Secondary

MeasureTime frameDescription
Tidal volume15 minutesMeasured at the end of each period
Comfort of breathing15 minutesSubjective evaluation at the end of each period
Blood gases15 minutesArterial or capillary blood gases at the end of each period
Dyspnea15 minutesEvaluation on a borg scale at the end of each period
Esophageal pressure-time product15 minutesMeasured at the end of each period
Heart rate15 minutesMeasured at the end of each period
End-tidal carbon dioxide15 minutesMeasured at the end of each period
Oxygen saturation15 minutesMeasured at the end of each period
Respiratory rate15 minutesMeasured at the end of each period

Countries

Canada

Contacts

Primary ContactMathieu Delorme, PT, MSc
mathieu.delorme.2@ulaval.ca418-656-8711
Backup ContactFrançois Lellouche, MD, PhD
francois.lellouche@criucpq.ulaval.ca418-656-8711

Outcome results

None listed

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