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.

Not Applicable

• Conditions: Extubation; ICU; High-Flow Nasal Oxygen Therapy; Non-invasive Ventilation; Respiratory Effort; Work of Breathing; Tidal Volume
• Interventions: Device: High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen

• Registration Number: NCT04036175
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-06
• Study First Submitted: 2019-06-17
• Status Verified: 2019-07
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-29
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-07-31
• Primary Completion: 2020-03-06
• Study Completion: 2020-03-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen	Standard oxygen - High-Flow Nasal Oxygen - Non-invasive ventilation - Standard Oxygen (20 minutes for each condition)
Group 2	High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen	Standard oxygen - Non-invasive ventilation - High-Flow Nasal Oxygen - Standard Oxygen (20 minutes for each condition)

Primary Outcome Measures

Name	Time	Method
Patient respiratory effort and tidal volume (Vt)	1h20	Swing of oesophageal pressure and pressure-Time product measured by a nasogastric pressure sensor tidal Volume estimated by electric impedance tomography

Secondary Outcome Measures

Name	Time	Method
Respiratory parameters	"Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"	transpulmonary pressure (cm H2O)
Hemodynamic parameters	"Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"	Systolic arterial pressure (PAS in mmHg), Diastolic arterial pressure (PAD in mmHg)
Comfort evaluation	"Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"	comfort evaluation with an visual evaluation scale graduate 0 cm (No discomfort) to 10 cm (maximal discomfort)

Trial Locations

Locations (2)

CHU Poitiers; 🇫🇷 Poitiers, France

Intensive reanimation; 🇫🇷 Poitiers, France