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Comparison of Patient Work of Breathing and Tidal Volumes With High Flow Nasal Cannula Oxygen Therapy and NIV (Non-Invasive Ventilation) After Extubation in the ICU.

Comparison of Patient Work of Breathing and Tidal Volumes With High-flow Nasal Cannula Oxygen Therapy and Non-invasive Ventilation After Extubation in the ICU: a Prospective, Randomized, Controlled Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04036175
Acronym
OVNI
Enrollment
25
Registered
2019-07-29
Start date
2018-03-06
Completion date
2020-03-06
Last updated
2019-07-31

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

Conditions

Extubation, High-Flow Nasal Oxygen Therapy, ICU, Non-invasive Ventilation, Respiratory Effort, Tidal Volume, Work of Breathing

Brief summary

This study is aimed at evaluating patient work of breathing and tidal volumes with three methods of oxygenation: standard oxygen, high-flow oxygen therapy and non-invasive ventilation.

Interventions

DEVICEHigh-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen

Device High Flow Nasal Oxygen: gas flow of 50L:Min and FiO2 adjusted to obtain SpO2\>= 92% Device NIV: Pressure-support level to achieve an expired tidal volume between 6 and 8 ml/kg and PEEP level of 5 cmH2O and FiO2 adjusted for SpO2\>= 92%

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

Inclusion criteria

* Minimum age: 18 years * planned extubation decided by the physician in charge of the patient after success of weaning trial * patients at high risk of reintubation according to the following criteria: patient older than 65 years, or those having any underlying chronic cardiac or lung disease * Hypoxemia defined by PaO2/FiO2 \< 300 mmHg under mechanical ventilation before extubation

Exclusion criteria

* Duration of mechanical ventilation prior to extubation \< 24h * Contraindication to NIV * Contraindication to nasogastric tube * Do-not-reintubated order at time of extubation * People under legal protection * Opposition to participate

Design outcomes

Primary

MeasureTime frameDescription
Patient respiratory effort and tidal volume (Vt)1h20Swing of oesophageal pressure and pressure-Time product measured by a nasogastric pressure sensor tidal Volume estimated by electric impedance tomography

Secondary

MeasureTime frameDescription
Respiratory parametersTime 0,Time 20 min, Time 40 min, Time 60 min, Time 120 minrespiratory rate (FR bt/min)
Hemodynamic parametersTime 0,Time 20 min, Time 40 min, Time 60 min, Time 120 minSystolic arterial pressure (PAS in mmHg), Diastolic arterial pressure (PAD in mmHg)
Comfort evaluationTime 0,Time 20 min, Time 40 min, Time 60 min, Time 120 mincomfort evaluation with an visual evaluation scale graduate 0 cm (No discomfort) to 10 cm (maximal discomfort)

Countries

France

Contacts

Primary ContactArnaud W. THILLE, PUPH
arnaud.thille@chu-poitiers.fr+33 5 49 44 38 54
Backup ContactCéline DELETAGE
celine.deletage@chu-poitiers.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026