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. (OVNI)

Poitiers University Hospital

Status: Unknown

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

Treatments: Device: High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT04036175

2017-A02838-45

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Group 1

Other group

Description:

Standard oxygen - High-Flow Nasal Oxygen - Non-invasive ventilation - Standard Oxygen (20 minutes for each condition)

Treatment:

Device: High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen

Group 2

Other group

Description:

Standard oxygen - Non-invasive ventilation - High-Flow Nasal Oxygen - Standard Oxygen (20 minutes for each condition)

Treatment:

Device: High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen