Respiratory Failure With HypoxiaVOLHYPOXNCT03445455
Assessment of Tidal Volume During Non Invasive Oxygenation Techniques
An observational study of Respiratory Failure With Hypoxia, run by Henri Mondor University Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure With Hypoxia
- What is being tested?
- Tidal volume measurement
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2018to 1 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with de novo acute hypoxemic respiratory failure
Who may be able to join
- Respiratory rate > 25 per minute
- PaO2/FiO2 < 200 mmHg
- PaCO2 < 45 mmHg
- Signed consent by patient or relative
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Tidal Volume by Electrical Impendance Tomography During Non Invasive Oxygenation Techniques in de Novo Hypoxemic Acute Respiratory Failure
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.
Read the detailed description
Background : De novo acute respiratory failure with moderate to severe hypoxemia is associated with high intubation and mortality rates. Under non-invasive ventilation (NIV) with a bucco-nasal mask, a high Tidal volume is associated with NIV failure and poor outcome. It is suspected that non-control of the Tidal volume may worsen the prognosis of the patient. Indeed, it is logical to consider that the physiopathological mechanisms that lead to ventilator induced lung injury (VILI) under mechanical ventilation, especially over-distension, can in the same way aggravate pulmonary lesions under NIV and even during spontaneous breathing. The value of the Tidal volume is available in non-invasive ventilation with the bucco-nasal mask, but it is unknown with the use of other non-invasive oxygenation techniques : oxygen therapy with the high concentration mask, non-invasive ventilation with the helmet, and high flow nasal canula.
Objectives : The main objective is to compare the Tidal volume received under different oxygenation techniques (oxygen therapy with high concentration mask, NIV with bucco-nasal mask and with helmet, high flow nasal canula), in patients with de novo acute hypoxemic respiratory failure and moderate to severe hypoxemia.
Methods : All patients admitted in intensive care for de novo acute hypoxemic respiratory failure, non hypercapnic, with moderate to severe hypoxemia (PiO2/FiO2 < 200 mmHg) will be included. Patients with one of the following items will be excluded : chronic respiratory disease, cardiogenic pulmonary edema, hemodynamic instability, coma, contraindication to NIV, indication for immediate intubation.
After inclusion, the Tidal volume will be measured for each technique with the use of electrical impedance tomography, in a random order. Randomisation will be carried out by using sealed envelopes containing a predetermined order. Each technique will be used for 15 minutes. For NIV with the bucco-nasal mask, the inspiratory pressure will be progressively adjusted to maintain the Tidal volume between 6 and 8 ml/kg of ideal body weight without dropping below 7 cm H2O and the positive expiratory pressure will be gradually increased to 5 cm H2O. For NIV with the helmet, the inspiratory pressure will be progressively increase to 12 cm H2O and the positive expiratory pressure will be gradually increased to 5 cm H2O. For high flow nasal canula,the gas flow will be set at 50 L/minute. FiO2 will be adjusted to keep SpO2 above 92%. To convert the thoracic impedance variations into absolute values of Tidal volumes, the airway flow signal will be collected with a pneumotacograph during the NIV with bucco-nasal mask session. The following data will also be collected : respiratory rate, comfort, regional Tidal volume in dependent and non-dependent areas and global inhomogeneity index, Pa02, PaCO2 and pH (If an arterial catheter is present). Signed consent will be required prior to any inclusion.
Expected benefits : This study will provide a better understanding of P-Sili and help define the place each non-invasive oxygenation techniques in the management of de novo acute respiratory failure.
- Conditions
- Respiratory Failure With Hypoxia
- Being tested
- Tidal volume measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tidal volume measurementDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Tidal volume measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal volume
in milliliter
Measured: Averaged value over the last 3 minutes of thoracic impedance recording
Secondary outcomes (7)
pH
Arterial blood gases will be collected only if an arterial catheter will be already inserted
Measured: After 15 minutes of using a non invasive oxygenation device
PaO2
in mm Hg; Arterial blood gases will be collected only if an arterial catheter will be already inserted
Measured: After 15 minutes of using a non invasive oxygenation device
PaCO2
in mm Hg; Arterial blood gases will be collected only if an arterial catheter will be already inserted
Measured: After 15 minutes of using a non invasive oxygenation device
Respiratory rate
in cycle/min
Measured: After 15 minutes of using a non invasive oxygenation device
Comfort
using a semiquantitative scale from 1 (the worst comfort) to 5 (the best comfort)
Measured: After 15 minutes of using a non invasive oxygenation device
Regional Tidal volume
in milliliter
Measured: Averaged value over the last 3 minutes of thoracic impedance recording
Global inhomogeneity index
in percentage
Measured: Averaged value over the last 3 minutes of thoracic impedance recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start1 Mar 2018 (estimated)
- Primary completion30 Jun 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Failure With HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henri Mondor University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Guillaume CARTEAUX, Henri Mondor University Hospital
- Investigators
- Guillaume Carteaux, MD, PhD, Principal investigator, Henri Mondor University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445455
- Sponsor's protocol ID
- 2017-A03560-53
- Acronym
- VOLHYPOX
- Status last verified
- Feb 2018
- First submitted
- 19 Feb 2018
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Tidal Volume by Electrical Impendance Tomography During Non Invasive Oxygenation Techniques in de Novo Hypoxemic Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT03445455
- Acronym / sponsor ID
- VOLHYPOX / 2017-A03560-53
- Conditions
- Respiratory Failure With Hypoxia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Henri Mondor University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background : De novo acute respiratory failure with moderate to severe hypoxemia is associated with high intubation and mortality rates. Under non-invasive ventilation (NIV) with a bucco-nasal mask, a high Tidal volume is associated with NIV failure and poor outcome. It is suspected that non-control of the Tidal volume may worsen the prognosis of the patient. Indeed, it is logical to consider that the physiopathological mechanisms that lead to ventilator induced lung injury (VILI) under mechanical ventilation, especially over-distension, can in the same way aggravate pulmonary lesions under NIV and even during spontaneous breathing. The value of the Tidal volume is available in non-invasive ventilation with the bucco-nasal mask, but it is unknown with the use of other non-invasive oxygenation techniques : oxygen therapy with the high concentration mask, non-invasive ventilation with the helmet, and high flow nasal canula.
Objectives : The main objective is to compare the Tidal volume received under different oxygenation techniques (oxygen therapy with high concentration mask, NIV with bucco-nasal mask and with helmet, high flow nasal canula), in patients with de novo acute hypoxemic respiratory failure and moderate to severe hypoxemia.
Methods : All patients admitted in intensive care for de novo acute hypoxemic respiratory failure, non hypercapnic, with moderate to severe hypoxemia (PiO2/FiO2 < 200 mmHg) will be included. Patients with one of the following items will be excluded : chronic respiratory disease, cardiogenic pulmonary edema, hemodynamic instability, coma, contraindication to NIV, indication for immediate intubation.
After inclusion, the Tidal volume will be measured for each technique with the use of electrical impedance tomography, in a random order. Randomisation will be carried out by using sealed envelopes containing a predetermined order. Each technique will be used for 15 minutes. For NIV with the bucco-nasal mask, the inspiratory pressure will be progressively adjusted to maintain the Tidal volume between 6 and 8 ml/kg of ideal body weight without dropping below 7 cm H2O and the positive expiratory pressure will be gradually increased to 5 cm H2O. For NIV with the helmet, the inspiratory pressure will be progressively increase to 12 cm H2O and the positive expiratory pressure will be gradually increased to 5 cm H2O. For high flow nasal canula,the gas flow will be set at 50 L/minute. FiO2 will be adjusted to keep SpO2 above 92%. To convert the thoracic impedance variations into absolute values of Tidal volumes, the airway flow signal will be collected with a pneumotacograph during the NIV with bucco-nasal mask session. The following data will also be collected : respiratory rate, comfort, regional Tidal volume in dependent and non-dependent areas and global inhomogeneity index, Pa02, PaCO2 and pH (If an arterial catheter is present). Signed consent will be required prior to any inclusion.
Expected benefits : This study will provide a better understanding of P-Sili and help define the place each non-invasive oxygenation techniques in the management of de novo acute respiratory failure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| De novo AHRF | – | Device: Tidal volume measurementAcute 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with de novo acute hypoxemic respiratory failure
Key inclusion criteria (4 listed)
- Respiratory rate > 25 per minute
- PaO2/FiO2 < 200 mmHg
- PaCO2 < 45 mmHg
- Signed consent by patient or relative
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tidal volume measurementRecording 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. | Device | De novo AHRF |
Primary outcome
Tidal volume
Time frame: Averaged value over the last 3 minutes of thoracic impedance recording
in milliliter
7 secondary outcomes
pH
Time frame: After 15 minutes of using a non invasive oxygenation device
PaO2
Time frame: After 15 minutes of using a non invasive oxygenation device
PaCO2
Time frame: After 15 minutes of using a non invasive oxygenation device
Respiratory rate
Time frame: After 15 minutes of using a non invasive oxygenation device
Comfort
Time frame: After 15 minutes of using a non invasive oxygenation device
Regional Tidal volume
Time frame: Averaged value over the last 3 minutes of thoracic impedance recording
Global inhomogeneity index
Time frame: Averaged value over the last 3 minutes of thoracic impedance recording
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Carteaux, MD, PhD principal investigator
Henri Mondor University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure With Hypoxia, run by Henri Mondor University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Carteaux, MD, PhD (+ 33 (0)1 49 8123 91, guilaume.carteaux@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tidal volume (time frame: Averaged value over the last 3 minutes of thoracic impedance recording). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2018.