Assessment of Tidal Volume During Non Invasive Oxygenation Techniques

NCT03445455 | Unknown

• 1 other identifier: 2017-A03560-53
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

High Tidal volume is one of the main mechanisms that lead to lung injuries under mechanical ventilation (ventilator induced lung injury: VILI). It could also induce lung damage during spontaneous or assisted ventilation (patient-self inflicted lung injury: P-SILI). Different non invasive oxygenation devices are available to deliver oxygen during acute hypoxemic respiratory failure: high concentration mask, high flow nasal canula and non-invasive ventilation (with bucco-nasal mask or helmet). The investigators hypothesized that the device may influence the tidal volume. Therefore, the objective of this study is to measure and compare the tidal volume during the use of each device. Tidal volume will be measured using Electrical impedence tomography.

Conditions

Respiratory Failure With Hypoxia

Outcome Measures

Primary Outcomes (1)

• Tidal volume

  in milliliter

  Averaged value over the last 3 minutes of thoracic impedance recording

Secondary Outcomes (7)

• pH

  After 15 minutes of using a non invasive oxygenation device

• PaO2

  After 15 minutes of using a non invasive oxygenation device

• PaCO2

  After 15 minutes of using a non invasive oxygenation device

• Respiratory rate

  After 15 minutes of using a non invasive oxygenation device

• Comfort

  After 15 minutes of using a non invasive oxygenation device

Study Arms (1)

De novo AHRF

Acute hypoxemic non hypercapnic respiratory failure with a PaO2/FiO2 ratio \< 200. The following oxygenation devices are used and assessed during routine care: High concentration mask, High flow nasal canula, NIV using buco-nasal mask or Helmet. Electro impedence tomography signal will be recorded throughout this assessement for tidal volume measurement

Device: Tidal volume measurement

Interventions

Tidal volume measurement DEVICE

Recording of thoracic impendance variations during different non-invasive oxygenation techniques. Conversion to Tidal volume after calibration using the airway flow signal recorded during the NIV with bucco-nasal mask.

De novo AHRF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with de novo acute hypoxemic respiratory failure

You may qualify if:

• Respiratory rate \> 25 per minute
• PaO2/FiO2 \< 200 mmHg
• PaCO2 \< 45 mmHg
• Signed consent by patient or relative

You may not qualify if:

• Chronic respiratory disease
• COPD exacerbation
• Acute asthma
• Cardiogenic pulmonary edema
• Hemodynamic instability (systolic blood pressure \< 90 mmHg or mean blood pressure \< 65 mmHg or use of catecholamines)
• Coma (Glasgow coma scale \< 12)
• Contraindication to non-invasive ventilation
• Indication to immediate intubation according to the physician

Sponsors & Collaborators

• Henri Mondor University Hospital: lead

Study Officials

• Guillaume Carteaux, MD, PhD

  Henri Mondor University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume Carteaux, MD, PhD

CONTACT

+ 33 (0)1 49 8123 91; guilaume.carteaux@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: February 26, 2018
• Study Start: March 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: September 1, 2019
• Last Updated: March 2, 2018

Record last verified: 2018-02