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.

ClinicalTrials.gov ID

NCT04036175

Lead Sponsor

Poitiers University HospitalOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

25Estimated

Last Update Posted

Jul 31, 2019Actual

Start Date

Mar 6, 2018Actual

Primary Completion Date

Mar 6, 2020Estimated

Completion Date

Mar 6, 2020Estimated

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

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.

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

• High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Crossover Assignment

Masking

None (Open Label)

Lead Sponsor

Poitiers University HospitalOTHER

+33 5 49 44 38 54

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