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.

Extubation Clinical Trial

— OVNI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04036175
• Other study ID #: 2017-A02838-45
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2018
• Est. completion date: March 6, 2020

Study information

• Verified date: July 2019
• Source: Poitiers University Hospital
• Contact: Arnaud W. THILLE, PUPH
• Phone: +33 5 49 44 38 54
• Email: arnaud.thille[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 6, 2020
• Est. primary completion date: March 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• High-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%

Locations

Country	Name	City	State
France	CHU Poitiers	Poitiers
France	Intensive reanimation	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient respiratory effort and tidal volume (Vt)	Swing of oesophageal pressure and pressure-Time product measured by a nasogastric pressure sensor tidal Volume estimated by electric impedance tomography	1h20
Secondary	Respiratory parameters	respiratory rate (FR bt/min)	"Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Secondary	Respiratory parameters	saturation (SpO2 in %)	"Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Secondary	Respiratory parameters	transcutaneous CO2 pressure (PCO2 in mm Hg)	"Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Secondary	Respiratory parameters	transpulmonary pressure (cm H2O)	"Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Secondary	Hemodynamic parameters	Systolic arterial pressure (PAS in mmHg), Diastolic arterial pressure (PAD in mmHg)	"Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Secondary	Comfort evaluation	comfort evaluation with an visual evaluation scale graduate 0 cm (No discomfort) to 10 cm (maximal discomfort)	"Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"